Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT07115992
Brief Summary:
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
Study:
NCT07115992
Study Brief:
Protocol Section:
NCT07115992