Using PSMA-PET/CT to guide lymph node surgery in prostate cancer patients
Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET/CT for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients
This study is testing if using a special imaging technique called PSMA-PET/CT can help doctors decide if prostate cancer patients need extra lymph node surgery to avoid unnecessary procedures and complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 706 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Canisius-Wilhelmina Hospital Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT05000827 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men with biopsy-proven prostate cancer, no distant metastasis, and a risk of lymph node involvement greater than 5%.
Not a fit: Patients with a history of treated prostate cancer or those with distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer invasive surgeries and reduced healthcare costs for prostate cancer patients.
How similar studies have performed: Other studies have shown promising results using imaging techniques like PSMA PET/CT for similar purposes, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nijmegen, Gelderland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.