John W Yaxley1, Geoffrey D Coughlin1, Suzanne K Chambers2, Stefano Occhipinti3, Hema Samaratunga4, Leah Zajdlewicz5, Nigel Dunglison1, Rob Carter6, Scott Williams7, Diane J Payton8, Joanna Perry-Keene8, Martin F Lavin9, Robert A Gardiner10. 1. Department of Urology, Royal Brisbane & Women's Hospital, Brisbane, QLD, Australia. 2. Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia; The University of Queensland Centre for Clinical Research, Brisbane, QLD, Australia; Edith Cowan University, Perth, WA, Australia; Cancer Council Queensland, Brisbane, QLD, Australia; Prostate Cancer Foundation of Australia, Sydney, NSW, Australia. 3. Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia. 4. The University of Queensland Centre for Clinical Research, Brisbane, QLD, Australia; Aquesta Specialized Uropathology, Brisbane, QLD, Australia; Princess Alexandra Hospital, Brisbane, QLD, Australia. 5. Cancer Council Queensland, Brisbane, QLD, Australia. 6. Deakin University, Melbourne, VIC, Australia. 7. Peter Macallum Cancer Centre, Melbourne, VIC, Australia. 8. Queensland Pathology, Brisbane, QLD, Australia. 9. The University of Queensland Centre for Clinical Research, Brisbane, QLD, Australia. 10. Department of Urology, Royal Brisbane & Women's Hospital, Brisbane, QLD, Australia; The University of Queensland Centre for Clinical Research, Brisbane, QLD, Australia; Edith Cowan University, Perth, WA, Australia. Electronic address: f.gardiner@uq.edu.au.
Abstract
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 toradical 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 theradical retropubic prostatectomy group versus six (4%) in the robot-assisted laparoscopic prostatectomy group had postoperative complications (p=0·052). 12 (8%) men receivingradical retropubic prostatectomy and three (2%) men receivingrobot-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.
RCT Entities:
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.
Authors: Robert Steven Gerhard; Dattatraya Patil; Yuan Liu; Kenneth Ogan; Mehrdad Alemozaffar; Ashesh B Jani; Omer N Kucuk; Viraj A Master; Theresa W Gillespie; Christopher P Filson Journal: Urol Oncol Date: 2017-01-12 Impact factor: 3.498
Authors: Martin Nyberg; Jonas Hugosson; Peter Wiklund; Daniel Sjoberg; Ulrica Wilderäng; Sigrid V Carlsson; Stefan Carlsson; Johan Stranne; Gunnar Steineck; Eva Haglind; Anders Bjartell Journal: Eur Urol Oncol Date: 2018-06-11
Authors: J L Donovan; F C Hamdy; J A Lane; D E Neal; M Mason; C Metcalfe; E Walsh; J M Blazeby; T J Peters; P Holding; S Bonnington; T Lennon; L Bradshaw; D Cooper; P Herbert; J Howson; A Jones; N Lyons; E Salter; P Thompson; S Tidball; J Blaikie; C Gray; P Bollina; J Catto; A Doble; A Doherty; D Gillatt; R Kockelbergh; H Kynaston; A Paul; P Powell; S Prescott; D J Rosario; E Rowe; M Davis; E L Turner; R M Martin Journal: N Engl J Med Date: 2016-09-14 Impact factor: 91.245