Extraperitoneal SINgle-site rObotic-assisted radical prostatectomy (RARP) versus transperitoneal multi-site RARP in the Treatment Of Prostate cancer (SINO-TOP): a multicenter, non-inferiority, randomized controlled trial study design

Background Radical Prostatectomy is the standard treatment for localized prostate cancer. Compared to open or laparoscopic approaches, multi-site robotic-assisted radical prostatectomy (msRARP) has been proved to improve postoperative functional recovery, tumor control and fewer surgical complications. With advancements in robotic surgical hardware and technology, single-site Vattikuti Institute Prostatectomy (VIP) (ss-RARP) enables the preservation of potency and reduction of surgical trauma through a single small incision and extraperitoneal access, thus achieving more satisfying clinical outcomes. Consequently, ssRARP is currently being widely promoted for application. However, its definitive clinical value requires rigorous validation. Therefore, our study is designed to clarify the non-inferiority of ssRARP over msRARP in terms of functional recovery, key perioperative indicators and tumor control by conducting a large-scale randomized controlled trial (RCT). Methods This study is designed as a multicenter and non-inferiority randomized controlled trial. Centers with an annual caseload of > 100 RARP volume are qualified to include patients after informed consent has been given. Surgeons must have ample experience performing RARP, including an annual caseload of 40 ssRARP procedures. A total of 480 (2 × 240) patients will be enrolled from 5 participating centers, and each center will randomly allocate patients to either the ssRARP group or the msRARP group at a 1:1 ratio. Patients’ baseline, clinical, and surgical data will be closely recorded, and follow-up visits will be scheduled at 1, 3, 6 and 12 months postoperatively. During each follow-up visit, the patients’ clinical outcomes were recorded. The impact on the functional recovery rate and PSA level will be calculated as the average difference between the groups with 95% confidence intervals. Conclusion This study is designed to clarify the clinical value of robotic radical prostatectomy with VIP techniques and to contribute to the development of evidence-based guidelines concerning surgical management for localized prostate cancer. Trial registration: Clinical trial identification number: NCT06238713. Registered on 2 February 2024.