Using PSMA-PET/CT to guide lymph node surgery in prostate cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of Prostate-Specific Membrane Antigen Positron Emission Tomography (PSMA PET/CT) as a tool to determine whether patients with prostate cancer should undergo extended pelvic lymph node dissection (ePLND) during surgery. Patients with biopsy-confirmed prostate cancer and a calculated risk of lymph node involvement greater than 5% will be randomized into two groups: one receiving ePLND based on PSMA PET/CT results and the other undergoing the standard procedure regardless of imaging results. The aim is to reduce unnecessary surgeries, lower healthcare costs, and minimize patient complications while maintaining similar disease outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Biopsy proven adenocarcinoma of the prostate
* Indication for ePLND combined with robot assisted radical prostatectomy (RARP) (MSKCC nomogram \>5%, if not applicable when only MRI targeted biopsies are positive, the Briganti nomogram will be used)
* Suitable for robot-assisted ePLND and RARP
* Mentally competent and understanding of benefits and potential burden of the study
* Written informed consent
* No known allergies for PSMA tracer.

Exclusion Criteria:

* History of prior diagnosed or treated PCa
* Known concomitant malignancies (except Basal Cell Carcinoma of the skin)
* Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RARP
* PSMA non-avid PCa (local tumor activity)
* Presence of distant metastasis (M1)

Where it's running

• Canisius Wilhelmina Ziekenhuis
  Nijmegen, Gelderland, Netherlands Recruiting

Study contacts

• Principal investigator: Jean-Paul A. van Basten — Canisius-Wilhelmina Hospital
• Study coordinator: Lieke Wever
• Email: l.wever@antoniusziekenhuis.nl
• Phone: 0681806668

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Epidemiology, diagnosis, and treatment patterns of prostate cancer in Algeria

  This project collects medical and treatment information to see how prostate cancer is diagnosed and managed in Algerian men with confirmed disease.

  Recruiting at 21 sites Société Algérienne de Formation et Recherche en Oncologie · Adrar, Algeria and 23 other locations · NCT07484971

• Treatment for advanced prostate cancer using Pluvicto

  This study is testing if a new treatment called Pluvicto can help men with advanced prostate cancer that has spread to their bones feel better and improve their quality of life.

  Recruiting Phase 2 Excel Diagnostics and Nuclear Oncology Center · Houston, Texas · NCT06972628

• 7-day water-only fasting for metastatic prostate cancer

  This study will test whether a 7-day water-only fast (with a ketogenic very low-calorie option) is safe and doable for people with metastatic prostate cancer.

  Recruiting Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT06826924

• Treatment for HER2-Positive Metastatic Castration-Resistant Prostate Cancer

  This study is testing a new drug called Enhertu to see if it can help people with a specific type of advanced prostate cancer who haven't had success with other treatments.

  Recruiting Phase 2 Washington D.C. Veterans Affairs Medical Center · Washington D.C., District of Columbia · NCT06610825

• Using a new type of PET scanner for imaging prostate cancer and related conditions

  This study is testing a new type of PET scanner to see if it can better detect early signs of prostate cancer and related conditions in patients.

  Recruiting Jagiellonian University · Krakow · NCT06242119

• Evaluating frailty and side effects in older men with metastatic prostate cancer receiving hormone therapy

  This study is trying to find out what makes older men with advanced prostate cancer feel weaker and have side effects while they are on hormone therapy.

  Recruiting University of Chicago · Chicago, Illinois · NCT06215508

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.