Preoperative PSMA PET/CT as Triage for ePLND in Patients Scheduled for RALP (PrePSMA) — PrePSMA  

Prostate Cancer Clinical Trial

Official title: Preoperative PSMA PET/CT as Triage for Extended Pelvic Lymph Node Dissection (ePLND) in Patients Scheduled for Robot-Assisted Laparoscopic Radical Prostatectomy (RALP)

Status Recruiting

Clinical Trial Summary

Extended pelvic lymph node dissection (ePLND) is considered the gold standard for nodal staging in men with prostate cancer (PCa). The aim of this project is to determine if preoperative prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomograpy (CT) can safely replace ePLND as a staging method in PCa patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP).

Clinical Trial Description

Eligible for the study is patients scheduled for RALP and ePLND according to current practice. Patients will be randomized between RALP and ePLND (Arm A) and PSMA PET/CT (arm B). If PSMA PET/CT detect suspicious pelvic nodes, the patient will undergo ePLND comcomitant with RALP. If PSMA PET/CT is negative, only RALP will be performed.

Primary outcome measures:

Difference in biochemical recurrence (BCR) rate between arm A and arm B within 2 years after initiation of primary treatment (BCR ≥ 0.2 ng/ml).

Secondary outcome measures:

Difference between Arm A and Arm B for surgical complications, persistent PSA after RALP and initiation of salvage therapy ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT06398613
• Study type: Interventional
• Source: Oslo University Hospital
• Contact: Viktor Berge, PhD
• Phone: +4791599615
• Email: vikber@ous-hf.no
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2024
• Completion date: December 31, 2029