Elsevier

The Lancet

Volume 388, Issue 10049, 10–16 September 2016, Pages 1057-1066
The Lancet

Articles
Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study

https://doi.org/10.1016/S0140-6736(16)30592-XGet rights and content

Summary

Background

The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology. We aimed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks.

Method

In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, were able to read and speak English, had no previous history of head injury, dementia, or psychiatric illness or no other concurrent cancer, had an estimated life expectancy of 10 years or more, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women's Hospital (Brisbane, QLD). Participants were randomly assigned (1:1) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patient's condition. Further, a masked central pathologist reviewed the biopsy and radical prostatectomy specimens. Primary outcomes were urinary function (urinary domain of EPIC) and sexual function (sexual domain of EPIC and IIEF) at 6 weeks, 12 weeks, and 24 months and oncological outcome (positive surgical margin status and biochemical and imaging evidence of progression at 24 months). The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months. We report here the early outcomes at 6 weeks and 12 weeks. The per-protocol populations were included in the primary and safety analyses. This trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12611000661976.

Findings

Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group. 121 assigned to radical retropubic prostatectomy completed the 12 week questionnaire versus 131 assigned to robot-assisted laparoscopic prostatectomy. Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (74·50 vs 71·10; p=0·09) or 12 weeks post-surgery (83·80 vs 82·50; p=0·48). Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (30·70 vs 32·70; p=0·45) or 12 weeks post-surgery (35·00 vs 38·90; p=0·18). Equivalence testing on the difference between the proportion of positive surgical margins between the two groups (15 [10%] in the radical retropubic prostatectomy group vs 23 [15%] in the robot-assisted laparoscopic prostatectomy group) showed that equality between the two techniques could not be established based on a 90% CI with a Δ of 10%. However, a superiority test showed that the two proportions were not significantly different (p=0·21). 14 patients (9%) in the radical retropubic prostatectomy group versus six (4%) in the robot-assisted laparoscopic prostatectomy group had postoperative complications (p=0·052). 12 (8%) men receiving radical retropubic prostatectomy and three (2%) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events.

Interpretation

These two techniques yield similar functional outcomes at 12 weeks. Longer term follow-up is needed. In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than a specific surgical approach.

Funding

Cancer Council Queensland.

Introduction

Prostate cancer is the second most common malignancy in men (excluding keratinocyte cancers) behind lung cancer, with more than 1 million cases estimated to be diagnosed worldwide in 2012.1 Historically, surgery has been the dominant approach for the treatment of localised disease; however, the high incidence of iatrogenic morbidities associated with open radical retropubic prostatectomy has led to the search for less invasive treatments to improve both oncological and quality of life outcomes. Since the first reported robot-assisted laparoscopic prostatectomy by Binder and Kramer2 in 2001, rapid adoption of this surgical technique has been made such that in many countries robot-assisted laparoscopic prostatectomy is becoming the dominant surgical approach for prostatectomy. Advocates of robot-assisted laparoscopic prostatectomy claim benefits of the technology lead to improved quality of life and oncological outcomes. Radical retropubic prostatectomy enthusiasts highlight the paucity of high-quality evidence for robot-assisted laparoscopic prostatectomy and contend that radical retropubic prostatectomy remains the gold standard technique. This creates confusion for men with localised prostate cancer who are presented with several management options and perspectives from various sources. Perhaps no other topic in the current era of urology has attracted so much attention, controversy, and debate in our community as has robot-assisted laparoscopic prostatectomy versus radical retropubic prostatectomy.3

Research in context

Evidence before this study

Robotic-assisted radical prostatectomy was introduced without high level evidence. The published literature so far has consisted of non-randomised longitudinal studies of robotically assisted and open prostatectomies (considered the gold standard in terms of treatment) alone or collated in meta-analyses, although there is randomised controlled trial evidence comparing robotically assisted and laparoscopic prostatectomy showing improved functional results for the robotically assisted procedure.

Added value of this study

To the best of our knowledge, this is the first published randomised controlled trial to compare robotic-assisted with open prostatectomy and shows no significant difference in outcome for standard oncological and quality of life parameters at 12 weeks.

Implications of all the available evidence

Over the past 2 decades, patients and clinicians have embraced robotic-assisted prostatectomy in the belief that this approach will result in better patient outcomes. If the short-term findings from this study are maintained with longer follow-up results, this could have implications for patient choice and for health provider decision making.

Building on previous research,4, 5, 6 we aimed to assess clinical and quality of life outcomes in radical retropubic prostatectomy compared with robot-assisted laparoscopic prostatectomy.

Section snippets

Study design and participants

In this phase 3 randomised controlled trial, men were recruited and managed throughout at the Royal Brisbane & Women's Hospital (RBWH) with referrals to the public clinics from general practice and the private practices of urologists in SE Queensland in Australia (see Gardiner and colleagues7 for the published protocol). The trial commenced 18 months after the introduction of robotic surgery to our institution, which was the only public centre with a robotic facility in our state. Only one

Results

Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group. The first patient underwent surgery in

Discussion

A meta-analysis showed improved early functional outcomes for robot-assisted laparoscopic prostatectomy compared with radical retropubic prostatectomy.22, 23 Our study does not support this finding, with no significant differences noted at any time up to 12 weeks between the groups with regard to the quality of life parameters of return of early urinary and sexual function. A recent prospective, controlled, non-randomised trial comparing robot-assisted laparoscopic prostatectomy with radical

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