Prostate Cancer Molecular Test Grid - Grand Rounds in Urology

3

February 2016

NCCN is a registered trademark of the National Comprehensive Cancer Care Network NCCN does not endorse any therapy or product AUA

is a registered trademark of American Urological Association AUA does not endorse any therapy or product1Adverse pathology is defines as high-grade andor non-organ-confined disease

NCCN Prostate Cancer Guidelines (NCCN Guidelines Version 12015)ldquoMen with clinically localized disease could consider use of a tumor-based molecular assay to stratify better risk of adverse pathology

at radical prostatectomy or chance of biochemical recurrence or disease-specific mortality after radical prostatectomyrdquo

Prostate Cancer Molecular Test Grid

Test Description Validated Endpoint(s)

Biomarker

Selection Specific

for Prostate

Cancer

Specimen Patient Access

Genomic Health

Genomic Prostate

Score (GPS)Predicts the likelihood of

adverse pathology1 using

multiple genetic pathways

Adverse Pathology at RPLikelihood of high-grade disease

Likelihood of non-organ-confined

disease

5-year BCR

NCCN Guidelinesreg

YES

Positive BiopsyNCCN Very Low Low

Low-intermediate risk

GS 3+3 3+4

Medicare Covered for

NCCN Very LowLowFinancial Assistance Available

Patient contacted if out-of-pocket

gt$100

Prolarisreg

Myriad Genetics

Cell Cycle

Progression Score

(CCP)Reports the risk of dying from

untreated disease in 10 years

using a single pathway

In a biopsy setting

10-year Untreated Mortality in a post-RP setting

10-year BCR

Metastasis

NCCN Guidelinesreg

NOProstatectomy

Positive BiopsyAUAreg Low-High Risk

Medicare Reimbursed for

NCCN Very LowLowFinancial Assistance Available


gt$375

ProMarkreg

Metamark

Genetics

ProMark ScorePredicts likelihood of adverse

pathology using protein

staining

Adverse Pathology at RPLikelihood of high-grade disease

Likelihood of non-organ-confined

disease

YES Positive BiopsyGS 3+3 3+4

Financial Assistance Available


gt$350

ConfirmMDxregMDx Health

ConfirmMDx resultPredicts likelihood of

negative repeat biopsy

Negative Repeat Biopsy YESNegative Biopsy

HGPIN Biopsy

Medicare Reimbursed Financial Assistance Available


gt$500

Decipherreg

GenomeDx

Bioscience

Genomic ClassifierPredicts the probability of

metastasis after surgery

5 -year Metastasis YESProstatectomy

pT3 or pT2 wpositive

margin

Medicare Reimbursed Financial Assistance Available


gt$395

4KScorereg

Opko

4KScoreProvides probability of

aggressive cancer

Likelihood of GS 3+4 and

higher at biopsyYES

BloodBiopsy-eligible patients

Financial Assistance is not reported

on website

Focal (non-radical) Therapy Debate- Pro

Innovations Conference

Prostate Cancer Session

Santa Fe NM 9152018

Jeffrey A Jones MD MS FACS FACPM FAsMA

Professor Baylor College of Medicine

Chief of Urology ME DeBakey VAMC

Topics

bull Debate defined

ndash What are we debating today

ndash Why does this topic need debating

bull Localized Disease Therapy Options

ndash Similar issues as that for Salvage (post XRT) Therapy

bull Current Outcome Data for RALP or RRP Cryotherapy HIFU (Descriptions for info)

ndash Trifecta

bull Oncologic control

bull Continence

bull Erectile Function

ndash Operative and Post-operative Complications

bull Discussion Reduce side effects Improve quality of life not just quantity

ndash A little unfair to Dr Davis since I put together and moderating the session and didnrsquot tell Dr Davis about my planhellip

bull But I knew I could not win a traditional argument in that I myself do not believe it

ndash Will not argue that radical prostatectomy is a better oncologic control operation

bull Same is true for radical nephrectomy radical mastectomy etc

ndash The debate from my perspective is can we achieve the desired oncologic outcome while reducing

bull Operative and Post-operative Complications

bull Incontinence

bull Erectile dysfunction

ndash We have learned from other cancer operations that more (radical) is not always better

ndash What is the best surgical strategy to achieve all of our outcome objectives for Prostate Cancer

Debate defined

ndash Active Surveillance Watchful Waiting

ndash Intervention

raquo Invasive

bull RRPRPP

raquo Less Invasive- Minimally Invasive

bull RALP- Robotic Assisted Laparoscopic +- PLND dominates current mgmt

bull EBRTBrachytherapy (HDRLDR) Proton Combination

bull EBRT- Conformal is being supplanted by IMRT

bull Brachy- isotope LDR still dominates

bull Proton- show me the cost effectiveness efficacy side effect data

bull Combination for higher risk and higher stage

bull Cryotherapy

bull Whole Gland Focal

raquo Minimally Invasive - Non-Invasive

bull HIFU - Physics Technique Current amp Future Role in PCA Management

Localized Disease Therapy Options

bull gt 15 published meta-analysis of radical prostatectomy surgical outcomes

bull gt 50 published comparison studies mostly retrospective reviews of single institutional series

bull Only a few prospective studies

bull Bottom line

ndash Improvements in blood loss hospital stay return to work post-op pain with RA

ndash But despite radical excision and robotic assistance

bull gt25 biochemical recurrence

bull 30+ with PP SUI and 10+ severe incontinence

ndash 5 of prostatectomy patients undergo continence surgery

bull 40+ with PP erectile dysfunction

RALP RARP and RP Outcomes

bull Published Series Examples


Author Pts Follow-Up (Months) Potency Rates ()

BNS UNS NNS Total McCammon et al[51] 203 42 452 305 167

Geary et al[52] 459 12 319 133 11 mdash

Penson et al[12] 1288 18 44 414 344 mdash

Catalona and Basler[32] 295 12 63 41 mdash

Leandri et al[53] 106 12 mdash mdash mdash 71

Drago et al[54] 151 mdash mdash mdash mdash 66

Walsh et al[7] 64 18 mdash mdash mdash 86

Kao et al[9] 1069 gt6 mdash mdash mdash 116

Guillonneau et al[14] 40 6 mdash mdash __ 45

Salomon et al[15] 143 12 875 50 30 56 __

Su et al[55] 177 12 76 mdash mdash 48

Outcome of interest No of studies Noof patientsRARPRRP ORWMD(95CI) dagger p-value Study heterogeneity

Chi2 df I2 p-value

Operation time min 10 15231435 4443[8018084] dagger 002 116656 9 99 lt00001

Estimated blood loss ml 8 10801102 -49341[-67209- 31474] dagger lt0001 21736 7 97 lt00001

Transfusion rate 18 162497209 016[009028] lt0001 11644 17 85 lt00001

Remove the catheter day 3 1173735 -178[-250-106] dagger lt0001 1952 2 90 lt00001

Hospital stay day 6 15681117 -075[-126-024] dagger 0004 7572 5 93 lt00001

Overall complications 14 27822767 050 [027 092] 003 15813 13 92 lt00001

Urinary continence-3mo 7 945818 121[074198] 045 1333 6 55 004

Urinary continence- 12mo 4 9421409 097[078120] 079 1089 6 45 009

Potent recovery-3mo 4 722685 450[1911062] lt0001 1764 3 83 lt0001

Potent recovery-12mo 4 9421409 158[105236] 003 1033 3 71 002

RALPRARP Outcomes

Readmission rate 4 28503025 053[023121] 013 2410 3 88 lt0001

Pathologic T stage

lepT2a 10 17251871 102[083126] 083 702 9 0 063

pT2b 9 16751821 099[080121] 090 807 8 1 043

gepT2c 12 19792212 098[079121] 084 948 11 0 058

Pathological Gleason score

le6 27 58476576 099[087113] 088 4537 26 43 001

7 27 58476576 114[102128] 002 4680 26 44 0007

ge8 27 58476576 079[067092] 0003 3831 26 32 006

PSM 39 1399217806 087[076099] 004 12338 37 70 lt0001

PSM for T2 16 66497986 071[053095] 002 5153 15 71 lt0001

PSM for T3 12 14231713 139[119163] lt0001 938 11 0 059

Mean LN yield 2 375275 377[-5871341] dagger 044 10654 1 99 lt0001

Positive lymph node 10 26683684 069[052090] 0006 931 9 3 041

BCR for free survival 5 11921797 116[071189] 055 2376 4 83 lt0001

RALP RARP Outcomes

bull Up to ~ 60 of patients with PCA are potentially candidates for alternative local treatment

ndash PCA who do not wish to remain on active surveillance due to up-grading up-staging or PSA rise ldquostressrdquo

ndash Localized disease who are not RALP candidates

ndash Localized disease who refuse RALPRRP due to concern for side effects

ndash Localized disease who are concerned about XRT effects

ndash Failed XRT for localized disease- next discussion

Candidates for Cryotherapy or HIFU

Cryotherapy Technique

Ice ball control varies by probe Endocare vs Galil

Cryotherapy Technique continued

Focal Cryotherapy Results

bull Not all HIFU is created equally

bull 2 major manufacturers

ndash EDAP-

bull Ablatherm

bull Focus One

ndash Sonacare-

bull Sonoblate

bull Sonotherm

HIFU- High Intensity Focused UltrasoundTechnique device comparison- technical features

Device (Focal One-FO Sonablate-SB) FO SB

Size of Rx Focal Zone (mm) 5 11

Tissue Change Monitoring - +

Power Control Adjustment - +

Duty Cycle Options - +

RIM box monitoring (Reflectivity Ind) - +

Automatic Margin around Target - +

Reference US for assessment - +

Auto-Overlapping Treatment Zones - +

Multi-modality with other probes - +

BU Probe provided - +

HIFU- High Intensity Focused UltrasoundTechnique device comparison- outcomes

References

Ahmed SCM 2016

Mortezim Swiss Urol 2017

Perez-Reggeti Acta Urol Esp 2017

Physics of Ultrasound HIFU- Effect

Diagnostic 1 ndash 20MHz

Therapeutic ndash HIFU 1-5MHz

Ablative Lesion-

3 x 3 x 12mm

Ultrasound energy is absorbed and converted to

heat in the focal zone- Temperature elevation

melts lipid membranes denatures proteins

produces vascular endothelial cell damage and

ultimately leads to coagulative necrosis

A New Management Paradigm

TargetFocal Ablation offers a clinical option between Surveillance and Surgery

SurgerySurveillance TargetFocal

Ablation

Earlier cancer diagnosis calls for surgeons to

expand their treatment paradigm

Sonablate HIFU System

bull 65 MHz imaging

bull 40 MHz transducer for treatment

bull Can be used with standard operating table

bull Single treatment protocol

bull Real-time power modulation control by the physician

bull Tissue change monitoring measures RF backscatter

bull Rectal wall cooling and rectal wall auto measurement

bull Reflex Index Monitoring for HIFU reverberation

bull Automatic rectal wall distance measurement

bull 3x2x12mm HIFU lesion

bull 40mm anterior to posterior (AP) reach

bull MRI fusion with several vendors ndash Phillips Eigen MiMrsquos UroNav

Imaging Crystal Therapy Crystal

40 mm geometric focus


bull 2-4 hour outpatient ldquoSurgery Center Basedrdquo procedure

bull Non-invasive transrectal probe using sound to create heat

bull 1-2 hour recovery

bull Most patients resume normal

lifestyle within a few days

bull Lower side effectives

bull Options for targeted ablation

bull Repeatable procedure

Sonablate Prostate HIFU Procedure

Robert Pugach MD

TCM is a unique quantitative software module that displays real-time

changes in prostate tissue destruction resulting from the HIFU ablation

Sonablate Real-Time Tracking

Tissue Change Monitoring (TCM)

Validation of TCM with Real-Time Thermometry

During HIFU in PCa Patients

83 ORANGE ( gt 75degC)

17 YELLOW (60-75degC)

Sonablate Prostate Ablation

Whole Gland Ablation

bull Sonablate ultrasound image guided HIFU ablation allows for a customizable ablation plan tailored to each patientrsquos prostate

bull This tailored ablation plan allows the user to ablate a whole or partial prostatic tissue

Hemi Gland Ablation Focal Gland Ablation

Prostate Multiparametric MRI

Diffusion Weighted (DWI)

Dynamic Contrast Enhancement

TMRI 2-Weighted

MR Spec

Post MRI Processing

Prostatic Margin Section

ROI Annotation

Anatomical Annotation

PIRAD Rating

Target Biopsy Systems

UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)

MRI Ultrasound Fusion

TRUS Surface

MRI Contours

TRUS Contours

MRI Surface

Sonablate Ultrasound

Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration

Prostate Technology Workflow

Sonablatebull DynaCAD-MRUS Fusion

bull HIFU Planning

bull HIFU Prostate Ablation

(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec

UroNavbull DynaCAD-MRUS Fusion

bull Bx Navigation

bull Bx Reporting

DynaCADbull Segmentation

bull ROI

Annotation

bull PIRADrsquos

Seamless platform for precise

diagnostics ablation and systematic

follow-up

Sonablate Focal HIFU AblationWith DynaCADUS Fusion

DynaCAD is a proprietary MRI post processing software from Invivo Inc A DynaCAD-MRI data set can be fused with

ultrasound within the UroNav Target Biopsy System and the Sonablate Prostate HIFU Ablation System







Prostate Tissue Ablation

bull Ultrasound image guided HIFU ablation allows for a customizable ablation plan tailored to each patientrsquos prostate

bull This tailored ablation plan allows the user to ablate a whole or partial prostatic tissueWhole Gland Ablation


Sonablate Study

Improved Outcomes with

Advancements in High

Intensity Focused Ultrasound

Devices for the Treatment of

Localized Prostate Cancer

Toyoaki Uchida Tetsuro Tomonaga Hakushi Kim

Mayura Nakano

Sunao Shoji Yoshihiro Nagata and Toshiro Terachi

From the Department of Urology Tokai University

Hachioji Hospital (TU TT HK MN SS YN)

Hachiojiand Department of Urology Tokai University

Isehara (TT) Japan

0022-5347151931-01030THE JOURNAL OF UROLOGYregcopy 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH INC

bull A total of 918 patients

bull Three different Sonablate models

bull Median follow up by Sonablate model

SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months

2 SB500(TCM) 271 47 months

Sonablate Study Overview

Improved Outcomes with Advancements in High Intensity Focused Ultrasound Devices for the Treatment of Localized Prostate Cancer Toyoaki Uchida Tetsuro

Tomonaga Hakushi Kim Mayura Nakano Sunao Shoji Yoshihiro Nagata and Toshiro Terachi

Sonablate Study Highlights






SB500(TCM)




SB500(TCM)



Medium-term Outcomes after Whole-gland High-intensity

Focused Ultrasound for the Treatment of Nonmetastatic

Prostate Cancer from a Multicenter Registry Cohort

L Dickinson M Arya N Afzal P Cathcart SC Charman A Cornaby R Hindley H Lewi N

McCartan CM Moore S Nathan C Ogden R Persad J van der Meulen S Weir M

Emberton Hashim U Ahmed Division of Surgery and Interventional Sciences University College London London UK Department of Urology UCLH

NHS Foundation Trust London UK Department of Urology Princess Alexandra Hospital NHS Trust Harlow UK Department of Urology Dorset County Hospital Dorchester UK

Department of Health Services Research and Policy London School of Hygiene and Tropical Medicine London UK Clinical Effectiveness Unit The Royal College of Surgeons of

England London UK Department of Urology Basingstoke Hospital Hampshire Hospitals NHS Foundation Trust Hampshire UK Department of Urology Broomfield Hospital Mid

Essex NHS Trust Chelmsford UK Department of Academic Urology The Royal Marsden Hospital NHS Foundation Trust London UK Department of Urology North Bristol NHS

Trust Bristol UK wwwsciencedirectcom journal homepage wwweuropea nurologycom Article history Accepted February 18 2016

Abstract- Background High-intensity focused ultrasound (HIFU) is a minimally-invasive treatment for

nonmetastatic prostate cancer Objective To report medium-term outcomes in men receiving primary

whole-gland HIFU from a national multi-center registry cohort Design setting and participants 569

patients at eight hospitals were entered into an academic registry Intervention Whole-gland HIFU

(Sonablate 500) for primary nonmetastatic prostate cancer Redo-HIFU was permitted as part of the

intervention Outcome measurements and statistical analysis Our primary failure-free survival outcome

incorporated no transition to any of the following (1) local salvage therapy (surgery or radiotherapy) (2)

systemic therapy (3) metastases or (4) prostate cancer-specific mortality Secondary outcomes included

adverse events and genitourinary function Results and limitations Mean age was 65 yr (47ndash87 yr)

Median prostate-specific antigen was 70 ngml (interquartile range 44ndash102) National Comprehensive

Cancer Network low- intermediate- and high-risk disease was 161 (28) 321 (56) and 81 (14)

respectively 163 569 (29) required a total of 185 redo-HIFU procedures Median follow-up was 46

(interquartile range 23ndash61) mo Failure-free survival at 5 yr after first HIFU was 70 (95 confidence

interval [CI] 64ndash74) This was 87 (95 CI 78ndash93) 63 (95 CI 56ndash70) and 58 (95 CI 32ndash77) for

National Comprehensive Cancer Network low- intermediate- and high-risk groups respectively 58 754

(77) had one urinary tract infection 22574 (29) a recurrent urinary tract infection 22754 (3)

epididymo-orchitis 227754 (30)

Medium Term Outcomes Following Focal HIFU for the

Treatment of Non-Metastatic Prostate Cancer a UK Registry

Analysis of 625 Cases

Guillaumier S1 Hamid S1 Charman S

C1 van der Meulen J1 McCartan N1

Shah K1 Hindley R3 Nigam R4

Dudderidge T4 Afzal N6 Cornaby A6

Lewi H7 Persad R8 Moore CM12

Arya M1 Emberton M12 Ahmed

HU12

UK Registry Study Overview of 625 Cases

Study Protocol-

bull UK prospective academic HIFU registry 2004 to 2015 (11 years)

bull 625 with T1aN0M0 to T3aN0M0 prostate cancer were treated with focal-HIFU (Sonablate)

bull 8 UK centres

bull Disease located via mpMRI followed by transperineal mapping biopsies andor MR-targeted

biopsies

bull Intermediate and high-risk cases underwent radioisotope bone-scan andor cross-sectional

CT

bull Focal-HIFU according to disease location involving hemi-ablation quadrant or focal lesion

ablation

bull Follow-up consisted of serial PSA readings repeat MRI and biopsies if clinically indicated

bull Positive biopsies of the contralateraluntreated area are defined as lsquoout-of-fieldrsquo recurrence

and are not considered to as treatment failure but as metachronous disease development

A B

UK Registry Data Results of 625 Cases

20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)

0 1 2 3 4 5 6Time since Focal HIFU (years)

625 586 497 433 374 252 126 Number at risk

Kaplan-Meier curve showing Metastases-free survival 95 Kaplan-Meier curve showing salvage-free survivial

at 3 years 95 and at 5 years 91

UK Registry Study Results of 625 Cases

Salvage Scenarios

Salvage Prostate Cancer Treatment Landscape

Primary Prostate Cancer Radiation Therapy

Conformal EBRT IMRT Proton Beam

PCa Failure Following Radiation up to 30

Rising PSA+ biopsy

Local recurrence amenable to control

Salvage (post XRT) Treatment Options [NCCN]ndash Salvage Radical Prostatectomy- RALPRRPRPP

ndash Salvage Brachytherapy (Focal vs Whole Gland)

ndash Cryotherapy (Focal vs WG)

ndash HIFU- High Intensity Focused Ultrasound (Focal vs WG)

ndash +- Lymph Node Dissection- PLNDePLNDRPLND

Multi-Institutional Salvage RP Data

Chade DC et al Salvage RP for radiation-recurrent prostate cancer Eur Urol (2011) 60205-10

Salvage RP Outcomes

Chade DC et al Cancer control and functional outcomes of salvage RP Eur Urol (2012) 61961-71

Perioperative

Conversion to open 0

Rectal injury 1

Ureteral injury 0 (0)

Vascular injury 0 (0)

OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23

MP45 - 1218Abstract 13-

1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12

30-day Complications

Salvage robot-assisted radical prostatectomy for

recurrent prostate cancer

Results


1796

Results


recurrent prostate cancer safety and feasibility

Functional outcomes

SHIM gt 21 11

Continence (no pad) 48

Oncologic outcomes

Biochemical failure (PSAgt02)

28

BF free-survival 1 y2 y3 y

716359

Multivariable analysis for BF OR 95 CI p

PSA ngml 1044 1004 ndash 1085 0029

Pathology Gleason (8 - 10 vs 6 - 7) 2890 1020 ndash 8191 0045

Median 13 months follow up

Rationality for Salvage Focal Therapy

bull In the lsquosalvagersquo setting after radiation failure

bull Recurrent Pca is more likely to occur at the same site as the primary dominant tumour

ndash thus lsquosuggesting supplementary focal therapy aimed at enhancing local tumor control would be a rational addition to managementrsquo

bull Step-section specimens of 46 salvage RPsndash 72 had a single unilateral focus

ndash Total cancer volume of 068 cm3

ndash Total cancer volume of 343 cm3 (278 cm3 for the index tumour and 018 cm3 for secondary tumours) naiumlve tumors

bull Recurrent cancer ndash Less volume

ndash More likely to be a single unilateral focus

ndash More amenable to targeted focal therapy than is lsquoprimary treatment-nai versquo PCa

bull Arrayeh E et al Does local recurrence of prostate cancer after radiation therapy occur at the site of primary tumor Results of a longitudinal MRI and MRSI study Int J Radiat Oncol Biol Phys 2012 82 e787ndash93

bull Pucar D et al Clinically significant prostate cancer local recurrence after radiation therapy occurs at the site of primary tumor magnetic resonance imaging and step-section pathology evidence Int J Radiat Oncol Biol Phys 2007 69 62ndash9

bull Huang WC et al The anatomical and pathological characteristics of irradiated prostate cancers may influence the oncological efficacy of salvage ablative therapies J Urol 2007 177 1324ndash9 quiz 1591

Salvage Cryotherapy

Finley D and A Belldegrun Curr Urol Rep (2011) 12209-215

Salvage Cryo Functional Outcomes

Study Patients Follow-up Age y Incontinence Baseline Potency Rectal Ureth UTI Hematuria LUTS Per pain AUR 2oPr

(mo) ED 6mo fistula Sx

Ng et al 18 NR 709 Mi-mod37 NR NR 2 0 10 11 Transient 39 14 21 8

Severe 3 Persistent 10

Pisters etal 279 216 700 Any pads 44 692 NR 12 NR NR NR NR NR 68 32

any leakage102

Perrotte 150 167 680 64ge1 pad 59 152 NR NR NR NR NR 44 NR NR

72 any leak

Donnelly 46 NR 689 65 persistent 804 556 22 0 8 7 2 2 4 3 217 65 217

Ismail et al 100 335 668 ge 1 pad 13 78 429 1 0 NR NR 16 4 2 NR

Yin et al 100 24 NR 30 NR 56 6 NR NR 6 NR 23 22 25

Bahn et al 59 823 675 43 NR NR 34 NR NR NR NR NR NR NR

Eisenberg 15 18 71 67 pads NR 40 0 6 7 NR NR NR NR NR NR

a Among prepotent men

b Hemiablation

AUR acute urinary retention ED erectile dysfunction LUTS lower urinary tract symptoms NR not reported UTI urinary tract infection

Curr Urol Rep (2011) 12209ndash215

Salvage Brachytherapy

Allen GW et al Cancer (2007) 1101405-16

Radiother Oncol 2012 Nov105(2)198-202 Epub 2012 Oct 12

Locally recurrent prostate cancer after initial radiation therapy early salvage

high-intensity focused (HIFU) ultrasound improves oncologic outcomesCrouzet S Murat FJ Pommier P Poissonnier L Pasticier G Rouviere O Chapelon JY Rabilloud M Belot A

Megravege-Lechevallier F Tonoli-Catez H Martin X Gelet A Edouard Herriot Hospital Lyon France

METHODS AND MATERIALS A total of 290 men with biopsy-confirmed locally radio-recurrent

PCa underwent S-HIFU DAmico risk group before external beam radiotherapy (EBRT)

Prostate Specific Antigen (PSA) estimated Gleason score prior HIFU and post HIFU biopsies

were analyzed for predictive utility of local cancer control cancer-specific metastasis free and

progression free survival rates (PFSR)

RESULTS Local cancer control with negative biopsy results was obtained in 81 of the 208

patients who underwent post-S-HIFU biopsies Median PSA nadir was 014 ngml and 127

patients did not require androgen deprivation therapy (ADT) The mean follow up was 48

months for cancer-specific survival rates The cancer-specific and metastasis-free survival rates

at 7 years were 80 and 796 respectively The PFSR was significantly influenced by the

pre-HIFU PSA level (hazard ratio (HR) 109 95 CI 104-113) a Gleason score ge8 versus le6

(HR 117 95 CI 103-13) and a previous ADT (HR 128 95 CI 109-146) The rates of

recto-urethral fistula (04) and grade IIIII incontinence (195) indicate significant

reduction in serious side effects with use of dedicated post-radiation acoustic parameters

compared with standard parameters

CONCLUSION S-HIFU is an effective curative option for radio-recurrent PCa with acceptable

morbidity for localized radio-recurrent PCa but should be initiated early following EBRT failure

Use of prognostic risk factors can optimize patient selection

Salvage Focal HIFU

bull Focal salvage high-intensity focused ultrasound in radiorecurrentprostate cancer

ndash N = 150

ndash 35 months follow up

bull Kanthabalan A et al BJU Int 2017 Aug120(2)246-256

bull Salvage high-intensity focused ultrasound (HIFU) for locally recurrent prostate cancer after failed radiation therapy Multi -institutional analysis of 418 patients

ndash Whole gland

ndash 35y follow up

ndash Crouzet S et al BJU Int 2017 Jun119(6)896-904

Salvage Outcomes Meta-analysisEur Urol Focus 2016 Jun2(2)158-171 doi 101016jeuf201509004 Epub 2015 Oct 4

Comparative Oncologic and Toxicity Outcomes of Salvage Radical Prostatectomy Versus

Nonsurgical Therapies for Radiorecurrent Prostate Cancer A Meta-Regression AnalysisPhilippou Y Parker RA Volanis D Gnanapragasam VJ Dept Surgery Basildon and Thurrock University Hospital Essex UK

Health Services Research University Edinburgh Edinburgh UK Dept Urology Addenbrookes University Hospital Cambridge U

ABSTRACT

Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement We included 63

articles in the analysis (25 on salvage radical prostatectomy (SRP) 8 on salvage high-intensity focused

ultrasound (SHIFU) 16 on salvage cryotherapy (SCT) 14 on salvage brachytherapy (SBT))

EVIDENCE SYNTHESIS Median values of the following variables were extracted from each study patient age

length of follow-up prostate-specific antigen (PSA) before radiotherapy (RT) PSA before salvage therapy

Gleason score before RT and time interval between RT and salvage therapy Functional toxicity and

oncologic outcomes were measured according to rates of impotence incontinence fistula formation urethral

strictures and biochemical recurrence Meta-regression adjusting for confounders found no significant

difference in oncologic outcomes between SRP and nonsurgical salvage modalities SBT SCT and

SHIFU appeared to have better continence outcomes than SRP No significant difference in toxicity

outcomes between modalities was found although limitations such as reporting selection and

publication bias and between-study heterogeneity must also be considered with these conclusions

CONCLUSIONS Oncologic outcomes are comparable for SRP and all three nonsurgical salvage modalities

We found no significant differences in toxicity outcomes among modalities however SRP appears to be

associated with worse rates of urinary incontinence than SBT SCT and SHIFU

PATIENT SUMMARY We performed a meta-regression analysis to compare oncologic functional and toxicity

outcomes between salvage radical prostatectomy and nonsurgical salvage modalities Oncologic and toxicity

outcomes appear to be similar however all nonsurgical salvage modalities may be associated with

better continence outcomes

HIFU as salvage first-line treatment for palpable TRUS-

evidenced biopsy-proven locally recurrent prostate

cancer after radical prostatectomy a pilot study

Asimakopoulos AD Miano R Virgili G Vespasiani G Finazzi Agrograve E Div Urology Univ Tor

Vergata Rome Italy

METHODS Nineteen patients with palpable TRUS-evidenced biopsy-proven local

recurrence of CaP after RP unwilling to undergo salvage radiotherapy (SRT) underwent

HIFU as a single-session procedure

RESULTS Median follow-up 48 months All cases overnight procedures No urethrorectal

fistula or anastomotic stricture was observed Two cases urinary retention were resolved

with urethral catheterization Four cases SUI 2 (mild incontinence) were resolved after

pelvic floor exercises within 6 mos 2 cases severe incontinence required surgical minimally

invasive treatment 1719 patients (89) were classified as success Two patients failed

to show a PSA nadir lt01 ngml During follow-up 817 patients (47) were classified as

failure with consequent total rate of failures 1019 (526) A statistically significant

difference was observed in pre-HIFU median PSA (2 vs 545 ngml respectively P = 0013)

and Gleason score of the RP specimen (P = 001) between the success and failure group

CONCLUSIONS Salvage first-line HIFU for palpable TRUS-evidenced biopsy-proven local

recurrence of CaP is a feasible minimally invasive day-case procedure with an acceptable

morbidity profile Fiar cancer control in the short- and mid-term Patients with lower pre-

HIFU PSA level and favorable pathologic Gleason score had better oncologic outcomes

Concomitant

Salvage Left-Hemi HIFU + Robotic (Xi) ePLND

Concomitant


Concomitant

Salvage Right-Hemi HIFU + Robotic (Si) PLND

Side docking

Case Presentations

CASE 1

bull JC ndash 57 YO plastic surgeon

bull PSA ndash 102

bull ~ 35 G prostate ndash felt benign

bull NBP ndash 512 cores ndash Gleason 4+4

bull ( - ) bone scan

bull ( - ) CT ndash abdomenpelvis

CASE 1 ( 2 )

bull Elected radical prostatectomy ( open )

bull Pelvic exploration ndash suspicious LN ndash Lt side

bull Frozen section ndash positive for metastatic

adenocarcinoma

bull Proceed with prostatectomy

bull Abort the procedure

CASE 1 ( 3 )

bull Had radical prostatectomy ndash 92006

bull Path Gl 4+4

18 cm ndash largest diameter

( + ) ECE

( + ) SVI

( + ) SM

( + ) LN ndash 10 cm in diameter

CASE 1 ( 4 )

bull Was started on ADT post-op

bull Continued on ADT x total of 8 months

bull Had XRT to the prostate bed ndash 6 months post-op

bull Followed since

CASE 1 ( 5 )

bull Last FU ndash 92017

bull Now 11 years since his operation

bull PSA - lt 0006 T ndash 487

bull Potent ( with viagra )

bull Continent ndash 0-1 padsday

CASE 2

bull RM ndash 70 yo real estate agent

bull PSA 267 30 free

bull DRE - ~ 35 G prostate cw T3 Rt gt Lt

bull NBP ndash Rt side ndash all cores GL 5+4 4+5

Lt side ndash GL 4+4 amp 4+3

bull Bone scan ndash ( - )

bull CT ndash Enlarged LNrsquos ndash Internal Iliac

CASE 2 ( 2 )

bull Elected multi ndash modal therapy

bull Had RALP + PLND 52017

bull Path 41 G prostate 65 replaced by tumor

bull GL 4+5 = 9

bull (+) SVI

bull (+) SM ndash Rt side amp apex

bull (+) LNrsquos ndash 28 ndash 21 mm largest diameter

bull Started ADT immediately post-op

mp-MRI + PSMA PETCT + TRUSFusion guided prostate biopsy

MRITarget

PETCT Target

Case 3

bull 80 YO male

bull 2004 PSA 55ngmL Gleason 3+3 212 cores

bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)

bull Bx 032016 Gleason 3+4 4+4 4+5 50 511 cores LB LM LA

bull History of

ndash Urinary retention

ndash Radiation cystitis

ndash CICrsquos 2-3xday and void on own 3xday

bull SHIM 1025 ndash sexually active w PDEI

Case 3

Case 3

bull TRUS (62016) Prostate volume 18 cc

bull NaF BonePET DJD changes no definitive mets

bull CT AP No metastases

Case 3

MRI- Asymmetry in diffusion and perfusion on the left- No SV involvement- No metastases

Salvage treatment options for

curative intentbull NCCN

ndashRadical prostatectomy + PLND

ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy

Salvage Right-Hemi HIFU +

Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs

bull Complications No

bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting

ndash Not concomitant

bull sHIFU first

ndash R lateral decubitus

bull Change to lithotomy

ndash Prep + Ports + Docking hellip

bull Robotic PLND

Follow-up at 4 monthsbull PSA 1098 (22016) 06 (112016) 103 (12017)

Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)


MRI targets orange and red All targeted and systematic BxPSMA PETCT target yellow

Adenocarcinoma of the prostate ASAP in the Right Base Only PSMA PET targeted Bx showed PCa

Prostatic adenocarcinoma with radiation associated changes

Salvage HIFU

Reference N FU (mos) Metric DFS ()

Gelet 71 148 BxPSA 44

Murat 167 181 BxPSA 42-53

Zacharakis 31 74 PSA(Bx) 71

Challacomb 12 21 PSA 25

Berge 46 9 PSA 61

Uchida 21 36 PSA 52

Ahmed 84 198 PSABx 43

Focal (non-radical) Therapy Debate- Pro

Innovations Conference

Prostate Cancer Session

Santa Fe NM 9152018

Jeffrey A Jones MD MS FACS FACPM FAsMA

Professor Baylor College of Medicine

Chief of Urology ME DeBakey VAMC

Topics

bull Debate defined






ndash Trifecta


bull Continence










bull Incontinence




Debate defined


ndash Intervention

raquo Invasive

bull RRPRPP








bull Cryotherapy








bull Bottom line












Geary et al[52] 459 12 319 133 11 mdash








Salomon et al[15] 143 12 875 50 30 56 __



Chi2 df I2 p-value











RALPRARP Outcomes


Pathologic T stage

lepT2a 10 17251871 102[083126] 083 702 9 0 063

pT2b 9 16751821 099[080121] 090 807 8 1 043

gepT2c 12 19792212 098[079121] 084 948 11 0 058


le6 27 58476576 099[087113] 088 4537 26 43 001

7 27 58476576 114[102128] 002 4680 26 44 0007

ge8 27 58476576 079[067092] 0003 3831 26 32 006

PSM 39 1399217806 087[076099] 004 12338 37 70 lt0001

PSM for T2 16 66497986 071[053095] 002 5153 15 71 lt0001

PSM for T3 12 14231713 139[119163] lt0001 938 11 0 059




RALP RARP Outcomes














ndash EDAP-

bull Ablatherm

bull Focus One

ndash Sonacare-

bull Sonoblate

bull Sonotherm














References

Ahmed SCM 2016






Ablative Lesion-

3 x 3 x 12mm









Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Topics

bull Debate defined






ndash Trifecta


bull Continence










bull Incontinence




Debate defined


ndash Intervention

raquo Invasive

bull RRPRPP








bull Cryotherapy








bull Bottom line












Geary et al[52] 459 12 319 133 11 mdash








Salomon et al[15] 143 12 875 50 30 56 __



Chi2 df I2 p-value











RALPRARP Outcomes


Pathologic T stage

lepT2a 10 17251871 102[083126] 083 702 9 0 063

pT2b 9 16751821 099[080121] 090 807 8 1 043

gepT2c 12 19792212 098[079121] 084 948 11 0 058


le6 27 58476576 099[087113] 088 4537 26 43 001

7 27 58476576 114[102128] 002 4680 26 44 0007

ge8 27 58476576 079[067092] 0003 3831 26 32 006

PSM 39 1399217806 087[076099] 004 12338 37 70 lt0001

PSM for T2 16 66497986 071[053095] 002 5153 15 71 lt0001

PSM for T3 12 14231713 139[119163] lt0001 938 11 0 059




RALP RARP Outcomes














ndash EDAP-

bull Ablatherm

bull Focus One

ndash Sonacare-

bull Sonoblate

bull Sonotherm














References

Ahmed SCM 2016






Ablative Lesion-

3 x 3 x 12mm









Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52








bull Incontinence




Debate defined


ndash Intervention

raquo Invasive

bull RRPRPP








bull Cryotherapy








bull Bottom line












Geary et al[52] 459 12 319 133 11 mdash








Salomon et al[15] 143 12 875 50 30 56 __



Chi2 df I2 p-value











RALPRARP Outcomes


Pathologic T stage

lepT2a 10 17251871 102[083126] 083 702 9 0 063

pT2b 9 16751821 099[080121] 090 807 8 1 043

gepT2c 12 19792212 098[079121] 084 948 11 0 058


le6 27 58476576 099[087113] 088 4537 26 43 001

7 27 58476576 114[102128] 002 4680 26 44 0007

ge8 27 58476576 079[067092] 0003 3831 26 32 006

PSM 39 1399217806 087[076099] 004 12338 37 70 lt0001

PSM for T2 16 66497986 071[053095] 002 5153 15 71 lt0001

PSM for T3 12 14231713 139[119163] lt0001 938 11 0 059




RALP RARP Outcomes














ndash EDAP-

bull Ablatherm

bull Focus One

ndash Sonacare-

bull Sonoblate

bull Sonotherm














References

Ahmed SCM 2016






Ablative Lesion-

3 x 3 x 12mm









Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52



ndash Intervention

raquo Invasive

bull RRPRPP








bull Cryotherapy








bull Bottom line












Geary et al[52] 459 12 319 133 11 mdash








Salomon et al[15] 143 12 875 50 30 56 __



Chi2 df I2 p-value











RALPRARP Outcomes


Pathologic T stage

lepT2a 10 17251871 102[083126] 083 702 9 0 063

pT2b 9 16751821 099[080121] 090 807 8 1 043

gepT2c 12 19792212 098[079121] 084 948 11 0 058


le6 27 58476576 099[087113] 088 4537 26 43 001

7 27 58476576 114[102128] 002 4680 26 44 0007

ge8 27 58476576 079[067092] 0003 3831 26 32 006

PSM 39 1399217806 087[076099] 004 12338 37 70 lt0001

PSM for T2 16 66497986 071[053095] 002 5153 15 71 lt0001

PSM for T3 12 14231713 139[119163] lt0001 938 11 0 059




RALP RARP Outcomes














ndash EDAP-

bull Ablatherm

bull Focus One

ndash Sonacare-

bull Sonoblate

bull Sonotherm














References

Ahmed SCM 2016






Ablative Lesion-

3 x 3 x 12mm









Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52





bull Bottom line












Geary et al[52] 459 12 319 133 11 mdash








Salomon et al[15] 143 12 875 50 30 56 __



Chi2 df I2 p-value











RALPRARP Outcomes


Pathologic T stage

lepT2a 10 17251871 102[083126] 083 702 9 0 063

pT2b 9 16751821 099[080121] 090 807 8 1 043

gepT2c 12 19792212 098[079121] 084 948 11 0 058


le6 27 58476576 099[087113] 088 4537 26 43 001

7 27 58476576 114[102128] 002 4680 26 44 0007

ge8 27 58476576 079[067092] 0003 3831 26 32 006

PSM 39 1399217806 087[076099] 004 12338 37 70 lt0001

PSM for T2 16 66497986 071[053095] 002 5153 15 71 lt0001

PSM for T3 12 14231713 139[119163] lt0001 938 11 0 059




RALP RARP Outcomes














ndash EDAP-

bull Ablatherm

bull Focus One

ndash Sonacare-

bull Sonoblate

bull Sonotherm














References

Ahmed SCM 2016






Ablative Lesion-

3 x 3 x 12mm









Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52






Geary et al[52] 459 12 319 133 11 mdash








Salomon et al[15] 143 12 875 50 30 56 __



Chi2 df I2 p-value











RALPRARP Outcomes


Pathologic T stage

lepT2a 10 17251871 102[083126] 083 702 9 0 063

pT2b 9 16751821 099[080121] 090 807 8 1 043

gepT2c 12 19792212 098[079121] 084 948 11 0 058


le6 27 58476576 099[087113] 088 4537 26 43 001

7 27 58476576 114[102128] 002 4680 26 44 0007

ge8 27 58476576 079[067092] 0003 3831 26 32 006

PSM 39 1399217806 087[076099] 004 12338 37 70 lt0001

PSM for T2 16 66497986 071[053095] 002 5153 15 71 lt0001

PSM for T3 12 14231713 139[119163] lt0001 938 11 0 059




RALP RARP Outcomes














ndash EDAP-

bull Ablatherm

bull Focus One

ndash Sonacare-

bull Sonoblate

bull Sonotherm














References

Ahmed SCM 2016






Ablative Lesion-

3 x 3 x 12mm









Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52



Chi2 df I2 p-value











RALPRARP Outcomes


Pathologic T stage

lepT2a 10 17251871 102[083126] 083 702 9 0 063

pT2b 9 16751821 099[080121] 090 807 8 1 043

gepT2c 12 19792212 098[079121] 084 948 11 0 058


le6 27 58476576 099[087113] 088 4537 26 43 001

7 27 58476576 114[102128] 002 4680 26 44 0007

ge8 27 58476576 079[067092] 0003 3831 26 32 006

PSM 39 1399217806 087[076099] 004 12338 37 70 lt0001

PSM for T2 16 66497986 071[053095] 002 5153 15 71 lt0001

PSM for T3 12 14231713 139[119163] lt0001 938 11 0 059




RALP RARP Outcomes














ndash EDAP-

bull Ablatherm

bull Focus One

ndash Sonacare-

bull Sonoblate

bull Sonotherm














References

Ahmed SCM 2016






Ablative Lesion-

3 x 3 x 12mm









Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52



Pathologic T stage

lepT2a 10 17251871 102[083126] 083 702 9 0 063

pT2b 9 16751821 099[080121] 090 807 8 1 043

gepT2c 12 19792212 098[079121] 084 948 11 0 058


le6 27 58476576 099[087113] 088 4537 26 43 001

7 27 58476576 114[102128] 002 4680 26 44 0007

ge8 27 58476576 079[067092] 0003 3831 26 32 006

PSM 39 1399217806 087[076099] 004 12338 37 70 lt0001

PSM for T2 16 66497986 071[053095] 002 5153 15 71 lt0001

PSM for T3 12 14231713 139[119163] lt0001 938 11 0 059




RALP RARP Outcomes














ndash EDAP-

bull Ablatherm

bull Focus One

ndash Sonacare-

bull Sonoblate

bull Sonotherm














References

Ahmed SCM 2016






Ablative Lesion-

3 x 3 x 12mm









Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52















ndash EDAP-

bull Ablatherm

bull Focus One

ndash Sonacare-

bull Sonoblate

bull Sonotherm














References

Ahmed SCM 2016






Ablative Lesion-

3 x 3 x 12mm









Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52



References

Ahmed SCM 2016






Ablative Lesion-

3 x 3 x 12mm









Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52





Ablative Lesion-

3 x 3 x 12mm









Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52





Ablation




bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52



bull 65 MHz imaging
























Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52











Robert Pugach MD

















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


















TMRI 2-Weighted

MR Spec

Post MRI Processing


ROI Annotation


PIRAD Rating


UroNav Invivo

Artemis Eigen

Symphony MiMS

Koelis (Q4 2016)


TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52



TRUS Surface

MRI Contours

TRUS Contours

MRI Surface


Dataset Contours

MRI Dataset

Section Annotation

MRIUSRegistration



bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52




bull HIFU Planning


(TCM)

mpMRIbull T2W

bull DWI

bull DCE

bull Spec


bull Bx Navigation

bull Bx Reporting


bull ROI

Annotation

bull PIRADrsquos



follow-up














Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52















Sonablate Study







Mayura Nakano





Isehara (TT) Japan





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52





SB Model n FU

1 SB200500 408 108 months

1 SB500(v4) 239 83 months











SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52








SB500(TCM)




SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


SB500(TCM)








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52








































HU12


Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52



Study Protocol-



bull 8 UK centres


biopsies


CT


ablation




A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


A B


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


20

60

40

80

10

0

0

Meta

sta

sis

-fre

e S

urv

iva

l (

) (9

5

CI)


625 586 497 433 374 252 126 Number at risk




Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Salvage Scenarios





Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52






Rising PSA+ biopsy









Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52




Salvage RP Outcomes


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Perioperative


Rectal injury 1



OpT (min) 166

EBL (ml) 118

Blood transfusion 0

LOS (days) 23


1796

Results N = 88

Clavien grade

I - II 8

III - IV 4

Total 12




Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Results


1796

Results



Functional outcomes

SHIM gt 21 11


Oncologic outcomes


28


716359


PSA ngml 1044 1004 ndash 1085 0029
















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52















Salvage Cryotherapy








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52








any leakage102


72 any leak







b Hemiablation



























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


























Salvage Focal HIFU


ndash N = 150




ndash Whole gland

ndash 35y follow up






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52






ABSTRACT
























Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52






Vergata Rome Italy

















Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Concomitant


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Concomitant


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Concomitant


Side docking

Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Case Presentations

CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


CASE 1


bull PSA ndash 102





CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


CASE 1 ( 2 )




adenocarcinoma



CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


CASE 1 ( 3 )


bull Path Gl 4+4


( + ) ECE

( + ) SVI

( + ) SM


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


CASE 1 ( 4 )




bull Followed since

CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


CASE 1 ( 5 )






CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


CASE 2








CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


CASE 2 ( 2 )




bull GL 4+5 = 9

bull (+) SVI





MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52



MRITarget

PETCT Target

Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Case 3

bull 80 YO male


bull 2010 EBRT

bull PSA 032 (2012) 38 (42014) 60 (42015) 48 (102015) 1098 (22016)


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


bull History of





Case 3

Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Case 3




Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Case 3





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52





ndashCryoablation

ndashHIFU + PLND

ndashBrachytherapy


Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52



Robotic PLND

bull PLND

ndash Right 09

ndash Left 06

bull ORT 5hs


bull LOS 1 day

Pre L sHIFU

Post L sHIFU


Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52



Robotic PLND

bull Same setting


bull sHIFU first




bull Robotic PLND


Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52



Follow-up at 1 year

PSA 1098 (22016) 06 (112016) 103 (12017) 114 (52017) 123 (82017)





Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52






Salvage HIFU






Berge 46 9 PSA 61

Uchida 21 36 PSA 52


Prostate Cancer Molecular Test Grid - Grand Rounds in Urology

Documents

Transcript of Prostate Cancer Molecular Test Grid - Grand Rounds in Urology