Ten-Years functional and oncological outcomes of a prospective randomised controlled trial comparing laparoscopic versus robot-assisted radical prostatectomy Running title: RARP vs LRP after 10 years of follow-up

Abstract Background: The aim of this study was to present oncological, functional and quality of life data after 10 years of follow-up of a prospective RCT comparing RARP vs LRP. Methods: This is a single center prospective parallel two arms randomized control trial for patients with localized PCa, who underwent LRP or RARP between January 2010 and January 2011. Functional (continence and potency) and oncological (PSA, biochemical recurrence [BCR] and BCR free survival [BCRFS] variables were evaluated. BCRFS curves were estimated by the Kaplan- Meier method and compared using the log-rank test. Furthermore, machine learning PLS-DA was tested as supervised multivariate data analysis to identify the variables that characterize more the patients who underwent RARP or LRP. Results and Limitations: of the 120 patients enrolled, 75 patients remained on follow-up for 10 years; 40 (53%) underwent RARP and 35 (47%) LRP. Long term data did not find significant advantages in terms of continence and potency recovery, despite a Δ12% for continence and Δ8% for potency in favour of robotic approach (p=0.068 and p=0.56 respectively). PLS-DA revealed that LRP was characterized by worst functional related outcomes analyzing the entire follow-up period. 4 (10%) and 6 (17%) patients experienced BCR in RARP and LRP Group respectively (p= 0.36) with an overall 10-yr BCR free survival of 88% and 78% (p=0.16). No differences were found at EPIC 45 and EPIC 1 questions at the end of the follow-up period (p = 0.30 and p = 0.57) respectively. Conclusions: Similar continence and potency rate were found between RARP and LRP at 10 years of follow-up. However, better quality of micturition and sexual outcomes at the end of long term follow-up was reached with a higher rate of totally dry patients and better erections in terms of IIEF-5 score in RARP cohort. Similar oncological outcomes reported.