Tag Archive for: randomized controlled trials

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Article of the Week: Comparing LRP and RARP to ORP to treat PCa

Every Week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Laparoscopic and robot‐assisted vs open radical prostatectomy for the treatment of localized prostate cancer: a Cochrane systematic review

 

Dragan Ilic*, Sue M. Evans, Christie Ann Allan*, Jae Hung Jung§¶, Declan Murphy** and Mark Frydenberg††

 

*Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Centre of Research Excellence in Patient Safety, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic., Australia, Department of Urology, Yonsei University Wonju College of Medicine, Wonju, Korea, §Department of Urology, University of Minnesota, Urology Section, Minneapolis VA Health Care System, Minneapolis, MN, USA, **Cancer Surgery, Peter MacCallum Cancer Centre, and ††Department of Surgery, Monash University, Melbourne, Vic., Australia

 

Abstract

Objective

To determine the effects of laparoscopic radical prostatectomy (LRP), or robot‐assisted radical prostatectomy (RARP) compared with open radical prostatectomy (ORP) in men with localized prostate cancer.

Materials and Methods

We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE) and abstract proceedings, with no restrictions on the language of publication or publication status, up until 9 June 2017. We included all randomized or pseudo‐randomized controlled trials that directly compared LRP and RARP with ORP. Two review authors independently examined full‐text reports, identified relevant studies, assessed the eligibility of studies for inclusion, extracted data and assessed risk of bias. We performed statistical analyses using a random‐effects model and assessed the quality of the evidence according to Grading of Recommendations Assessment, Development and Evaluation (GRADE). The primary outcomes were prostate cancer‐specific survival, urinary quality of life and sexual quality of life. Secondary outcomes were biochemical recurrence‐free survival, overall survival, overall surgical complications, serious postoperative surgical complications, postoperative pain, hospital stay and blood transfusions.

Results

We included two unique studies in a total of 446 randomized participants with clinically localized prostate cancer. All available outcome data were short‐term (up to 3 months). We found no study that addressed the outcome of prostate cancer‐specific survival. Based on one trial, RARP probably results in little to no difference in urinary quality of life (mean difference [MD] −1.30, 95% confidence interval [CI] −4.65 to 2.05; moderate quality of evidence) and sexual quality of life (MD 3.90, 95% CI: −1.84 to 9.64; moderate quality of evidence). No study addressed the outcomes of biochemical recurrence‐free survival or overall survival. Based on one trial, RARP may result in little to no difference in overall surgical complications (risk ratio [RR] 0.41, 95% CI: 0.16−1.04; low quality of evidence) or serious postoperative complications (RR 0.16, 95% CI: 0.02–1.32; low quality of evidence). Based on two studies, LRP or RARP may result in a small, possibly unimportant improvement in postoperative pain at 1 day (MD −1.05, 95% CI: −1.42 to −0.68; low quality of evidence) and up to 1 week (MD −0.78, 95% CI: −1.40 to −0.17; low quality of evidence). Based on one study, RARP probably results in little to no difference in postoperative pain at 12 weeks (MD 0.01, 95% CI: −0.32 to 0.34; moderate quality of evidence). Based on one study, RARP probably reduces the length of hospital stay (MD −1.72, 95% CI: −2.19 to −1.25; moderate quality of evidence). Based on two studies, LRP or RARP may reduce the frequency of blood transfusions (RR 0.24, 95% CI: 0.12–0.46; low quality of evidence). Assuming a baseline risk for a blood transfusion to be 8.9%, LRP or RARP would result in 68 fewer blood transfusions per 1,000 men (95% CI: 78–48 fewer).

Conclusions

There is no evidence to inform the comparative effectiveness of LRP or RARP compared with ORP for oncological outcomes. Urinary and sexual quality of life appear similar. Overall and serious postoperative complication rates appear similar. The difference in postoperative pain may be minimal. Men undergoing LRP or RARP may have a shorter hospital stay and receive fewer blood transfusions.

Editorial: RARP and a Parachute

Radical prostatectomy is probably the most scrutinized, debated and re‐invented procedure in the field of urology. This is with good reason. Dr Hugh Hampton Young gave the first formal account of a radical treatment for prostate cancer in 1905. It was a procedure performed perineally with the prime intention of total cancer extirpation. The oncological results were tremendous given the nascency of the procedure. Functional outcomes, however, were less so, with only ~25% of the patients achieving urinary continence and almost none achieving potency 1. Seminal studies undertaken by Drs Patrick C. Walsh and Pieter J. Donker in the 1980s led to the next major advance in technique: nerve‐sparing. It lead to dramatic improvements in sexual and urinary function preservation, with urinary continence achieved in upwards of 90% and potency in upwards of 60% of patients 23. Nerve‐sparing retropubic radical prostatectomy was rapidly adopted by urologists across the world. No randomized trial was conducted as the operation ‘made sense’, and it would have been unethical to offer patients an alternative, inferior operation. Retropubic radical prostatectomy, however, remained a morbid operation that was difficult to master; 1 200 mL blood loss and 20% incontinence, 15% stricture and 60–90% erectile dysfunction rates were the norm. Robot‐assisted surgery changed much of this. This surgery was perfected and popularized by Dr Mani Menon and his team at the Henry Ford Hospital. Blood loss dropped to ~100 mL, and incontinence and stricture rates today are ~1–5% with potency rates between 70% and 80% 4.

In the systematic review by Ilic et al. 5 trials that compared open with minimally invasive radical prostatectomy were evaluated. The authors are commended for combing through vast quantities of data to arrive at the final sample of two clinical trials (one laparoscopic, one robot‐assisted). The authors found no data on oncological endpoints. With respect to functional outcomes, the data reported in their systematic review are essentially from the recent Yaxley trial. It is true that randomized controlled trials form the backbone of medical progress, but they must be interpreted with care. The Yaxley trial has been criticized for comparing surgeons of vastly varying surgical expertise (1 500‐case experience for open prostatectomies, 200‐case experience for robot‐assisted prostatectomies), having a small sample size (~150 patients in each arm) and having a limited follow‐up (3 months). In line with this, Dr Gordon Smith has eloquently argued about the judicious use of randomized trials in evidence‐based medicine in his classic paper on parachutes and gravitational challenge 6. It is our sincere belief that robot‐assisted radical prostatectomy is a procedure in the service of the patients, and we believe that anyone who has performed both an open radical prostatectomy and a robot‐assisted radical prostatectomy would agree. Operating deep in the pelvis and being able to visualize the anatomy up‐close with robotic assistance ‘makes sense’, much like the anatomical radical prostatectomy did in the 1980s 23.

‘If it ain’t broke, don’t fix it’, the old saying goes. In case of radical prostatectomy, the converse has been true, for the most part. The procedure is still not perfect, and nuances need to be worked out. Nonetheless, over the last century, radicalprogress has been made in the surgery for prostate; the two issues that now remain to be solved are: improving potency and improving cost‐effectiveness. With the potential arrival of competing robotic systems and improvements in technology, the costs associated with robotic surgery may become less of an issue in the future. With regard to potency, focal therapies, whether surgical or otherwise, hold promise.

Akshay SoodFiras Abdollah, and Mani Menon
Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA

 

 

References
  • Young HH. The cure of cancer of the prostate by radical perineal prostatectomy (prostato‐seminal Vesiculectomy): History, Literature and Statistics of Young’s Operation1J Urol 194553: 188–252

 

 

 

  • Menon M, Dalela D, Jamil M et al. Functional recovery, oncologic outcomes and postoperative complications after robot‐assisted radical prostatectomy: an evidence‐based analysis comparing the Retzius sparing and standard approachesJ Urol 2018199: 1210–7

 

  • Ilic D, Evans SM, Allan CA, Jung JH, Murphy D, Frydenberg M. Laparoscopic and robot‐assisted vs open radical prostatectomy for the treatment of localized prostate cancer: a Cochrane systematic reviewBJU Int 2018121: 845–53

 

  • Smith GC, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trialsBMJ 200320: 1459–61

 

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