Efficacy and Safety of Radical Prostatectomy (RP) With or Without Salvage Radiotherapy Versus RP With Extended Pelvic Lymph Node Dissection for Localized Intermediate- and High-risk Prostate Cancer With a Briganti Nomogram≥7%

The goal of this clinical trial is to evaluate efficacy and safety of radical prostatectomy (RP) with or without salvage radiotherapy versus RP with extended pelvic lymph node dissection (ePLND) in males who have localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%. The main questions this study aim to answer are: 1. Is RP with or without salvage radiotherapy non-inferior to RP with ePLND in efficacy for patients with localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%? 2. Will complication rates of RP with or without salvage radiotherapy be significantly lower than those of RP with ePLND? Researchers will compare the experimental arm (robot-assisted laparoscopic radical prostatectomy with or without salvage radiotherapy) versus the control arm (robot-assisted laparoscopic radical prostatectomy with ePLND) to see if differences exist in oncological efficacy and safety outcomes. Participants will: 1. Undergo one of the following surgical interventions: 1. Robot-assisted laparoscopic radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND), OR 2. RARP alone, followed by salvage radiotherapy only if biochemical recurrence occurs postoperatively 2. Complete scheduled monitoring activities: 1. Serum PSA testing: Monthly or every 3 months within 2 years after surgery 2. PSMA PET/CT scans: Annually until study completion 3. Report all treatment-related complications within 24 hours of onset

NCT Number	NCT07115992
Lead Sponsor	Ruijin Hospital
Conditions	Prostate Cancer, Prostate Adenoma
Enrollment	270 participants
Start Date	2025-07-30
Primary Completion	2028-02-29 (estimated)
Study Completion	2028-02-29 (estimated)
Updated on ClinicalTrials.gov	2025-08-26