Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients

NARecruitingINTERVENTIONAL
Enrollment

706

Participants

Timeline

Start Date

July 28, 2021

Primary Completion Date

July 31, 2025

Study Completion Date

August 31, 2026

Conditions
Prostate Cancer MetastaticProstate CancerLymph Node Metastases
Interventions
DEVICE

PSMA-PET/CT

In the intervention arm patients will only undergo ePLND in addition to robot-assisted radical prostatectomy (RARP) in case of suspected LNI on PSMA PET/CT (miN1), whereas ePLND will be omitted in those without PSMA positive lymph nodes (miN0).

OTHER

Nomogram

Current standard of care includes performing extended pelvic lymph node dissection (ePLND) in all patients with primary prostate cancer and a nomogram-based risk of LNI \>5%

Trial Locations (1)

6532 SZ

RECRUITING

Canisius Wilhelmina Ziekenhuis, Nijmegen

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

Canisius-Wilhelmina Hospital

OTHER