Robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy yielded similar domain-specific quality-of-life or pathologic outcomes at 12 weeks in men with newly diagnosed, clinically localized prostate cancer, according to the results of a randomized phase III trial reported by John W. Yaxley, MBBS, FRACS, of Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia, and colleagues in The Lancet. Longer-term follow-up in these patients is ongoing.
A total of 326 men with newly diagnosed, clinically localized prostate cancer were enrolled in this phase III randomized controlled trial. These men were recruited and managed throughout at the Royal Brisbane and Women’s Hospital, with referrals to the public clinics from general practice and the private practices of urologists in Southeast Queensland in Australia.
Inclusion criteria were no history of head injury, dementia, or psychiatric illness; no other concurrent cancer; an estimated life expectancy of 10 years or more; and age between 35 and 70 years. Patients were excluded from the study if they had evidence of nonlocalized prostate cancer clinically; a prostate-specific antigen (PSA) level greater than 20 ng/mL; previous laparoscopic hernia repair, pelvic radiotherapy, or major pelvic surgery; and another malignancy within the past 5 years (with the exception of nonmelanoma skin cancer).
Patients were randomly assigned to receive either radical retropubic prostatectomy (163 patients) or robot-assisted laparoscopic prostatectomy (163 patients). (A total of 18 patients [12 assigned to the open approach and 6 assigned to the laparoscopic approach] withdrew from the study.) Study investigators involved in data analysis were blinded to each patient’s condition, and a masked central pathologist assessed the biopsy and radical prostatectomy specimens.
Scheduled assessment points were at baseline, 24 hours (for pain), 1 week (for pain), 6 weeks, 12 weeks, 6 months, 12 months, and 24 months. Primary outcomes were urinary function (urinary domain of the Expanded Prostate Cancer Index Composite [EPIC]) and sexual function (sexual domain of EPIC and the International Index of Erectile Function Questionnaire [IIEF]) and oncologic outcome (positive surgical margin status and biochemical and imaging evidence of disease progression at 24 months). Secondary outcomes were pain (assessed with the Surgical Pain Scale), physical and mental functioning (Short Form 36 Health Survey [SF-36]), fatigue (vitality domain of SF-36), preference-based utility scores (Assessment of Quality of Life [AQoL]-8D), bowel function (EPIC), cancer-specific distress (Revised Impact of Events Scale), psychological distress (Hospital Anxiety and Depression Scale), and time to return to work.
Similar Outcomes at 12 Weeks
There were no significant differences in urinary function scores between the open and laparoscopic groups at 6 weeks after surgery (74.50 vs 71.10; P = .09) or 12 weeks after surgery (83.80 vs 82.50; P = .48). Nor were there significant differences in sexual function scores between the open and laparoscopic groups at 6 weeks after surgery (30.70 vs 32.70; P = .45) or 12 weeks after surgery (35.00 vs 38.90; P = .18). In addition, at 12 weeks, no significant differences were noted in physical and mental quality of life as well as bowel quality of life.
Although equivalence analyses performed for the proportion of positive surgical margins could not establish equivalency between the two surgical approaches, a superiority test showed that the two proportions were not significantly different (P = .21).
The investigators concluded: “This randomised phase 3 trial of robot-assisted laparoscopic prostatectomy versus radical retropubic prostatectomy standardised for all relevant parameters did not find a difference in domain-specific quality of life or pathological outcomes at 12 weeks for the two surgical approaches.” Until the findings of 2-year follow-up have been published, the authors “encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than choose a specific surgical approach.”
The study was funded by Cancer Council Queensland.