Randomized Comparison between Laparoscopic and Robot-Assisted Nerve-Sparing Radical Prostatectomy Anastasios D. Asimakopoulos, MD,* Clovis T. Pereira Fraga, MD, † Filippo Annino, MD, ‡ Patrizio Pasqualetti, MD, § Adriano A. Calado, MD, ¶ and Camille Mugnier, MD** *Department of Surgery, Division of Urology, University of Tor Vergata, Policlinico Tor Vergata, Rome, Italy; † Serviço de Urologia do Instituto de Medicina Integral Prof. Fernando Figueira—IMIP—Recife/PE, Brazil; ‡ Department of Urology, University of Modena & Reggio Emilia, Modena, Italy; § Medical Statistics and Information Technology, Fatebenefratelli Association for the Research, Isola Tiberina, Rome, Italy; ¶ Departamento de Urologia, Hospital Universitário Oswaldo Cruz/Universidade de Pernambuco, Recife/PE, Brazil; **Department of Urology, Clinique Saint Augustin, Bordeaux, France DOI: 10.1111/j.1743-6109.2011.02215.x ABSTRACT Introduction. Lack of randomized controlled trials (RCTs) that compare pure laparoscopic radical prostatectomy (LRP) with robot-assisted laparoscopic radical prostatectomy (RALRP) is an important gap of the literature related to the surgical treatment of the clinically localized prostate cancer (PCa). Aim. To provide the first prospective randomized comparison on the functional and oncological outcomes of LRP and RALRP for the treatment of the clinically localized PCa. Methods. Between 2007 and 2008, 128 consecutive male patients were randomized in two groups and treated by a single experienced surgeon with traditional LRP (Group I-64 patients) or RALRP (Group II-64 patients) in all cases with intent of bilateral intrafascial nerve sparing. Main Outcome Measures. Primary end point was to compare the 12 months erectile function (EF) outcomes. Complication rates, continence outcomes, and oncological results were also compared. The sample size of our study was able, with an adequate power (1-beta > 0.90), to recognize as significant large differences (above 0.30) between incidence proportions of considered outcomes. Results. No statistically significant differences were observed for operating time, estimated blood loss, transfusion rate, complications, rates of positive surgical margins, rates of biochemical recurrence, continence, and time to continence. However, the 12-month evaluation of capability for intercourse (with or without phosphodiesterase type 5 inhibitors) showed a clear and significant advantage of RALRP (32% vs. 77%, P < 0.0001). Time to capability for intercourse was significantly shorter for RALRP. Rates of return to baseline International Index of Erectile Function (IIEF-6) EF domain score questionnaires (questions 1–5 and 15) (25% vs. 58%) and to IIEF-6 > 17 (38% vs. 63%) were also significantly higher for RALRP (P = 0.0002 and P = 0.008, respectively). Conclusions. Our study offers the first high-level evidence that RALRP provides significantly better EF recovery than LRP without hindering the oncologic radicality of the procedure. Larger RCTs are needed to confirm if a new gold-standard treatment in the field of RP has risen. Asimakopoulos AD, Pereira Fraga CT, Annino F, Pasqual- etti P, Calado AA, and Mugnier C. Randomized comparison between laparoscopic and robot-assisted nerve-sparing radical prostatectomy. J Sex Med 2011;8:1503–1512. Key Words. Prostate Cancer; Prostatectomy; Robot-Assisted Prostatectomy; Laparoscopic Prostatectomy; Erectile Function Outcome of Prostate Cancer Surgery; Potency Introduction R adical prostatectomy (RP) is a recognized and validated treatment for localized prostate cancer (PCa) in patients with a life expectancy of at least 10 years [1]. The number of RPs has been increasing annually, and currently, many patients are treated at younger ages [2]. Erectile dysfunction 1503 © 2011 International Society for Sexual Medicine J Sex Med 2011;8:1503–1512