Résumé
Background: radical prostatectomy (RP) is one of reference treatment for localized prostate cancer. Robot-assisted radical prostatectomy (RARP) is widely performed nowadays although there is no high-grade evidence of its superiority over open retropubic prostatectomy (ORP).Objective: to report functional and oncological outcomes between ORP and RARP with a 24 month follow-up. Design, setting, and participants: this was a prospective and observational study. Between November 26, 2012 and April 21, 2016, we recruited 90 men (45 in each group), aged 45 to 75 with localized prostate cancer in 3 different French centers. Patients were matched on age and D’Amico risk group.Outcome measurements and statistical analysis: the economic endpoints will be published later. The dataset is currently being analyzed. We compared erectile dysfunction (ED) and urinary symptoms, respectively estimated by a generalized linear mixed-effect model on IIEF-15 and QLQ-PR25 scores collected at inclusion (before surgery) and month 1, 6, 12 and 24 after surgery, between RARP versus ORP techniques. Oncological outcomes compared are positive margins at 1 month and biological recurrence within 24 months using a mixed logistic regression model.Results and limitation: ED score showed no significant difference between groups at any time with majority of severe erectile dysfunction after surgery. Positive margins rate did not differ significantly between procedures (32.6% for RARP vs 20.5% for ORP, p=0.2311). There was no difference in biological recurrence within 24 months between groups (25.9% for RARP vs 40% for ORP, p=1). Urinary symptoms did not differ significantly between techniques within 24 months (Median PRURI score=12.5 at 24 months for RARP vs 8.33 for ORP, p=0.711). Main limitations are absence of randomization and small sample size.Conclusions: our study showed similar results for carcinologic control and functional outcomes between the two surgical approaches. We believe it would be interesting to carry out a medico-economic study to help clarify the real benefits of robotic surgery.Patient summary: for prostate cancer surgery, both open and robotic approaches are efficient. However, radical prostatectomy has a strong impact on the functional results, particularly erectile function.