Comparing Extended Pelvic Lymph Node Removal to No Removal During Radical Prostatectomy in Men with High-Risk Prostate Cancer and Negative PSMA PET Scans

What this Trial Is About

This research aims to determine whether performing an extended pelvic lymph node dissection ePLND during radical prostatectomy benefits men with high-risk prostate cancer. The study investigates if ePLND improves cancer staging and removes undetectable cancer cells that standard imaging techniques like PSMA-PET might miss, potentially leading to better treatment outcomes. The trial is a multicenter, randomized phase III study sponsored by University Hospital, Basel, Switzerland. Participants will be randomly assigned to one of two groups radical prostatectomy with extended pelvic lymph node dissection or radical prostatectomy without the extended lymph node dissection. Extended PLND involves removing more lymph nodes than the standard procedure, aiming for better detection of cancer spread. The study compares outcomes between these two approaches, while considering surgery time and complication risks, which may be slightly higher with ePLND. During the study, participants will be monitored over a long-term period of up to 10 to 15 years. Researchers will measure prostate-specific antigen PSA persistence about 3 months after surgery and track biochemical recurrence-free survival within 24 months. Secondary measures include time to recurrence, metastasis, survival rates, complications, adverse events related to ePLND, and patient-reported outcomes. This comprehensive follow-up includes assessments during surgery, postoperatively, and over many years to evaluate the overall impact of the surgical approaches.

Extended vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy. DISSECTION 2.0.