Oncological results of PROPENLAP, prospective multicentric trial comparing open to mini-invasive radical prostatectomy (with and without robotic assistance)

Purpose: to report 3-years oncological results of PROPENLAP, a prospective multicenter trial comparing open to laparoscopic (with or without robotic assistance) radical prostatectomy Methods: PROPENLAP was a prospective, controlled, non randomized trial of patients undergoing radical prostatectomy in 13 centres using open or laparoscopic with or without robotic assistance radical prostatectomy. Inclusion criteria were: age < 70 years, having a biopsy-proven prostate cancer, clinical stage T1c, PSA < 20 ng/ml Specimen of radical prostatectomy were analysed according to the Stanford protocol; double centralized examination by anatomopathologist experts in prostate cancer and blinded from type of surgery No adjuvant treatment was given without biological progression defined by PSA >0.2 ng/ml and increasing. The primary end-point was a 3-year BCR rate defined as postoperative PSA level > 0.2 ng/ml, without any adjuvant treatment. The secondary end-points were positive surgical margins, operative time, blood transfusion, lymnphadenectomy results, peri and post operative morbidity. Results: From December 2008 to April 2011, 586 of 612 eligible patients, were included in the study, 240 for open retropubic approach (OR), 346 for laparoscopic approach (LP), 246 without robotic assistance (PLR) and 110 with robotic assistance (RLP) Patients from the open retropubic group were less likely to have comorbidities, had a higher percentage of positive biopsy results, were more likely to have a PSA level >10, and had more intermediate d’Amico risk relative to the laparoscopic group. Regarding pathological results, there were no significant differences between the groups in term of prostatectomy Gleason score or pathological stage. Operating time was shorter with robot assisted laparoscopy prostatectomy, blood loss was less important with mini-invasive surgery, specifically with robot-assisted laparoscopy procedure. There were 78 (13.3%) biochemical progression. There were no statistically significative difference in 36 months biological free survival between the three approaches and between open retropubic group and the laparoscopy group and between the open retropubic group and the laparoscopy group according to pathogical staging. As regard to secondary outcomes, no significant differences were observed in terms of positive surgical margins, operative time, blood transfusion, post operative complications according to Clavien’s classification, or hospital stay. Regarding the laparoscopic groups, in a multivariate Cox model, a trend towards a lower BCR rate was observed in the robot-assisted group (HR, 0.38, 95% CI [0.13-1.08], P = 0.07). Patients from the non-assisted laparoscopy group with a pT2 stage were more likely to have positive surgical margins, while no difference was observed for pT3. Non-assisted laparoscopic procedure was longer relative to the robot-assisted laparoscopic procedure with more important blood loss and blood transfusions. Conclusion: Laparoscopic (with or without robotic assistance) radical prostatectomy is non inferior to open retropubic radical prostatectomy in term of 3-year carcinological results. Laparoscopic with robotic assistance seems to offer oncological advantages in comparison with laparoscopic without robotic assistance radical prostatectomy.