STATE OF THE ART: SURGICAL TREATMENT OF LOCALISED DISEASE

Bob Djavan, Professor of Urology,

Chairman Department of Urology, Rudolfiner Foundation Hospital Vienna,

Executive Board ESOU Chairman Regional office of the EAU

HISTORY REVISITED !

Actuarial PSA Progression-free and Cancer Specific Survival after RP

Number of Patients at risk For Ca Specific Survival 1716 1225 915 359

63 for PSA Recurrence 1716 1115 724 214

38

PSA Progression

Ca Specific Survival

77% 75%

96% 93%

Swindle et al. J Urol;174(3):903-7, 2005

CONTINENCE at 1 year

Author N % Author N %

Ravery 567 79 Geary 458 80Rassweiler 500 84 Rassweiler 219 90Salomon 100 90 Steiner 593 94Bollens 275 94+ Leandri 620 95+

Total USA 79 -94ESRPE 82-96

+ 1 safety padDjavan et al, BJU, 2007

Time Kinetics of Continence

Time Range (%)

3 Months 51 - 63 6 Months 70 - 81 12 Months 91 - 9624 Months 92 - 97

Potency rates at 1 yr (bilateral NS)

Author N % Author N %

Salomon 17 59 Huland 366 56Rassweiler 41 67 Catalona 798 68Roumeguere 26 63 Roumeguere 33 55Eden 58 64 Walsh 64 86+

Total USA 59-67ESRPE 56-86

Open and Laparoscopic RPE

• Oncological results (R0 Margins) • Continence • Preservation of sexual function • Pain & QoL

Suture of dorsal vein complexOpen RPE

Suture of dorsal vein complex Laparoscopic RPE

Suture of dorsal vein complex Robotic RPE

Djavan 2009/211/B277

Incision Length

•Lap. RPE 7.9 cm

•Open RPE 8.6 cm

Postoperative Pain

• Comparison of 314 open and 154 robotic RP • Patient-reported pain scores were similar • Perioperative narcotic use was similar

• Authors concluded that outcomes other than pain and early convalescence will ultimately determine the role of lap/robotic RP

Webster et al. J Urol 174: 912, 2005

Bhayani, et al. Urology 61: 612-616, 2003.

Lap vs open RP : QOL studies

I Hara, J Urol, 169. 2045. 2003

LAP vs Open

• Oncologial results: No Difference • Continence: No Diference • Potency: No Difference • Pain & QoL: No Difference • Surgical Technique maters and not the

Approach • SUO, AUA, 2008

Eastham et al, J Urol , 2006

Overall potency results

Eastham et al, J Urol A, 2006

Touijer StudyJ Urol, May 179:1811, 2008

• No difference in oncological oucome • Less blood loss with laparoscopic approach • BUT higher number of post OP visits • Higher readmission rates • Continence better with open approach • Potency quicker with laparoscopy

Oncological outcome

The Early Studies

Open/Lap/Robotic RPE

2000-2010

One surgeon with 2 approaches Outcome measures

Open surgery (N=160)

Robotic laparoscopy (N=160)

Body mass index 27 26Operating time (hours) 3.6 3.9Positive margins (%) 12% 10%Blood loss (mL) 418 103*

Transfusion rate: % 1% 0%Hospital stay (days) 2.2 1.1*

Catheterisation time (days) 9 7Complications 10% 6.7%Continence at 3 months 75% 76%N = 120; * P < 0.05

Ahlering et al. Urol;63:819-22, 2005

Schroek Study BJU int Jul, 102:28, 2008

• Robot vs open RPE • N = 797 patients • No difference in oncological outcome • No difference in PSA recurence free survival • No difference in clinical and pathological

features, SM

Frotta & Gill Study Int Br J Urol, Jun;34(3):259 2008

• Robot vs open RPE vs LAP • Literature analysis 1982-2007 • G square ANALYSIS • No difference in oncological outcome • No difference in functional outcome • Equivalent in intermediate follow up

Parsons Metanalysis Urology, Aug, 72:412, 2008

• No difference in pos surgical margins (SM) • No difference in erection status (slightly

better with open and robot than lap) • No difference in continence status • Less blood loss with lap and robotic

ESOU Hamburg 2012

37 comparative studies - 16 prospective studies - one single PRT

Meta-analysis Eur Urol 2009

ED

Incont

GU compl

Strictures

Misc surg compl

Resp compl

BT

LOS

0,0 % 7,5 % 15,0 % 22,5 % 30,0 %

2,0 %

2,7 %

4,3 %

4,3 %

5,8 %

4,7 %

15,9 %

26,8 %

3,0 %

20,8 %

6,6 %

5,6 %

14,0 %

2,1 %

12,2 %

19,2 %

RRPMIRP

The Newer Studies

open/Lap/Robotic RPE

2010-2017

Medicare Study Barry et al., JCO, 30(5), 513, 2012

• Medicare patients 2008 • 685 patients • No difference in erection status • No difference in continence status • Patients should not expect fewer adverse

events following robotic prostatectomy

ONCOLOGIC OUTCOME

79 selected papersNovara et al. Eur Urol 62 (2012) 382-404

■ BIOCHEMICAL RECURRENCE FREE SURVIVAL • Very few papers with a follow-up duration >5 yr demonstrated 7-yr BCR-free survival

estimates of approximately 80%

■ COMPARISON BETWEEN RARP AND OTHER APPROACHES • SIMILAR PSMs rates (overall and pT2) and BCR-free survival estimates

Open vs Robotic assisted RPEin HIGH RISK

▪ UCSF Study ▪ 177 vs 233 patients ▪ Is RALP suitable in high risk? ▪ RALP less Blood loss and more Bilat Nerv

sparing cases ▪ Higher Postive Margins with RALP early on ▪ Equal recurrence rates at 2 and 4 yrs FU!

Punnen and Carroll, BJU Int, march, 2013

PASADENA CONSENSUS PANEL

PASADENA CONSENSUS PANEL

■ RARP is EQUIVALENT to RRP in terms of biochemical disease-free survival:

95.1% at 1 yr; 90.6% at 3 yr; 86.6% at 5 yr; 81.0% at 7 yr

■ RARP may be used in patients with high-risk cancers

■ PSMs rates after RARP are EQUIVALENT to those reported after RRP and LRP

Average rate of PSMs: in pT2= 8–10%; in pT3= 37%

■ When appropriately performed, RARP DOES NOT expose patients to an increased risk of adjuvant therapies

Open vs Lap vs Robotic assisted RPE

▪ UK NHS study ▪ Higher Costs with the Robot ▪ Growing evidence for lower surgical margins

and better potency results ▪ But: need > 150 cases to achieve better results

with the Robot. ▪ If < 150 cases: Open better!

Close et al, Eur Urol, march, 2013

Open vs Lap vs Robotic assisted METANALYSIS

▪ MED and EMBASE ▪ Random effect metanalysis ▪ Robotics better than Laparoscopy! ▪ In pT2: PSM and Potency better with Robotics

than with Open at 12 months !!

Moran PS et al, Int J Urol, march, 2013

Conclusions:

Lower overall likelihood of PSMs and adjuvant therapy with RARP versus ORP.

URINARY CONTINENCE

51 selected papers

■ PREVALENCE AND RISK FACTORS FOR URINARY INCONTINENCE POST-RARP = no pad! 12-mo urinary incontinence rates: mean value 16% (4%-31%) • Increasing age • BMI >30 • Prostate volume (cut-off value: 70-80 cm3) • Comorbidities • LUTS severity • Surgeon experience

Ficarra et al. Eur Urol 62 (2012) 405-417

URINARY CONTINENCE■ SURGICAL TECHNIQUES ABLE TO IMPROVE URINARY CONTINENCE RECOVERY Posterior musculofascial reconstruction (with or without anterior reconstruction):

slight advantage in terms of 1-mo urinary continence recovery

Significant ADVANTAGES for RARP in comparison with RRP/LRP in terms of 12-mo urinary continence rates

POTENCY RATES

31 selected papers

■ PREVALENCE AND POTENTIAL RISK FACTORS OF ERECTILE DYSFUNCTION POST-nerve sparing RARP

12-mo erectile dysfunction: 10%-46% 24-mo: 6%-37%

• Age at surgery • Baseline erectile function • Nerve-sparing extension and techniques

Ficarra et al. Eur Urol 62 (2012) 418-430

POTENCY RATES■ SURGICAL TECHNIQUES ABLE TO IMPROVE POTENCY RECOVERY Interfascial VS intrafascial dissection: inconclusive results Athermal dissection: significant advantages in terms of early potency recovery

Significant ADVANTAGES for RARP in comparison with RRP in terms of 12-mo potency rates

Non statistically significant trend in favor of RARP in comparison with LRP

Complications of Robotic RPE

• Migration of cases to low volume centers • Significantly higher CR in low volume

centers 14.7% vs 5.7% • Reduction in quality of patient care • Increase in Costs (vs highvolume centers)

Sammon et Menon, BJU Int, march, 2015

Cost comparison of robotic, laparoscopic and open radical prostatectomy

RALP LRP openRPE

OR Time (median) 235 225 198 0.001 Length of stay (median) 1 2 2 <0.001 Direct Cost (median, $) 6623 5636 3631 <0.001 OR Service Cost (median, $) 3175 2111 1260 <0.001 Surgical Supply Cost (median, $) 1314 1488 246 <0.001 Anesthesia Cost (median, $) 419 365 234 <0.001 Medication Cost (median, $) 296 271 270 0.001 Room and Bed Cost (median, $) 514 699 708 <0.001 Lab Cost (median, $) 295 386 657 <0.001

Gupta, Caddedu et al, Eur Urol, A 973, 2009

+150/+280%

Yaxley et al. – Lancet 2016• RCT, open (163) versus robot (163) prostatectomy • Localized prostate cancer, Brisbane, 2 surgeons

Urinary function

Sexual function

6 weeks

P=0.09 P=0.45

12 weeks

P=0.48 P=0.18

Open

Robot

Positive margins 10% 15% P=0.21Complications 9% 4% P=0.052

Beginners learn much faster the robot than laparsocopy or…

Virtual Surgery

Flight Simulator LUFTHANSAFlugsimulatoren wurden 1939 von Edward Link eingeführt um

Piloten auf schwierige Situationen vorzubereiten

Laguna, M. P., Hatzinger, M., and Rassweiler, J.: Simulators and endourological training. Curr Opin Urol, 12: 209, 2002

Oncological outcome

Urinary continence

Potency

CLINICAL PRACTICE

TotalRARP

ORP

DO OPEN SURGEONS BENEFIT FROM ROBOTIC EXPERIENCE?

• Open Survey of senior open surgeons having had robotic training and performed > 50 RALP cases

• n= 24 senior urologists with >500 cases each

• 6 countries • 15/24 believe they have changed significantly the open procedure

• 6/24 believe they have changed moderately • 3/24 have not changed

Conclusions• Robotic RPE better if high volume center only!

•Benefits: slight earlier recovery of continence and potency and May be oncological benefit

•“Robot assisted Open Surgery”

• Robotic exposure seems to improve the open technique

• Basis: 1) better perception of the anatomy 2) changing the technical approach

ESOU Hamburg 2012

„A Fool with a Tool is still….a

Fool…“

Me and Konfuzius

The Rudolfinerhaus Foundation Hospital

First oRPE by Theodor Billroth In 1867

My Message

Even if you don’t have a Robot, go and get robotic training/exposure, It will improve your open technique