Robot-assisted laparoscopic prostatectomy (RALP) results in similar functional outcomes at 12 weeks to open radical retropubic prostatectomy, according to new randomized study results published in The Lancet.
For the phase 3 trial, 163 men with clinically localized prostate cancer (aged 35 to 70) from the Royal Brisbane & Women’s Hospital in Queensland, Australia, were randomly assigned to RALP and 163 to open prostatectomy. To minimize heterogeneity, the same surgeon performed all RALP and another all open procedures from 2010 to 2015. In the 12 weeks after surgery, 131 and 121 men, respectively, completed questionnaires, such as the Expanded Prostate Cancer Index Composite (EPIC) and International Index of Erectile Function (IIEF).
Results showed that urinary function scores did not differ significantly between groups at 12 weeks after prostatectomy (83.8 vs 82.5 for open and RALP, respectively). Sexual function scores also appeared similar between groups (35.0 vs 38.9, respectively).
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Neither procedure proved superior in the short-term in the proportion of patients with positive surgical margins.
Not surprisingly, RALP patients appeared to have better perioperative outcomes, such as shorter operation time, fewer adverse events, less blood loss, fewer complications, and shorter hospital stay. Fourteen patients (9%) in the open surgery group and 6 (4%) in the RALP group had post-operative complications and 8% and 2% of men, respectively, experienced intraoperative adverse events. These outcomes did not translate into an earlier return to work, however.
These early findings are not expected to alter current practice. “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,” study author John W. Yaxley, MBBS, and colleagues concluded. The investigators look forward to reporting 1 and 2 year outcomes once the data becomes available for all patients.
The findings should be viewed as positive, “showing the innovation has preserved the intended and well established purpose of surgical intervention, such as good oncological outcomes balanced against acceptable functional side-effects,” remarked Erik Mayer, MBBS, PhD, clinical senior lecturer in urology, and Ara Darzi, MD, professor of surgery, both of Imperial College London in the UK, in an accompanying editorial. The editorialists also noted an important study limitation. Since the study did not fully accrue, it might have insufficient power to detect important differences in oncologic outcomes, such as biochemical recurrence and adjuvant treatment.
Sources
1. 1. Yaxley JW, Coughlin GD, Chambers SK, et al. Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study. Lancet. 2016 Jul 26. doi: 10.1016/S0140-6736(16)30592-X. [Epub ahead of print]
2. 2. Mayer E and Darzi A. Innovation and surgical clinical trials. Lancet. 2016 Jul 26. doi:10.1016/S0140-6736(16)30588-8. [Epub ahead of print]
