NCT05000827Recruiting
Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy 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
Source: ClinicalTrials.gov · Last updated 21 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) as a selection tool for performing extended lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs, lower patient burden in terms of intervention-related complications and morbidity, with comparable disease prognosis, compared to the current European Guideline-recommended standard practice which includes performing ePLND in PCa patients who are candidates for active treatment with a nomogram-calculated lymph node involvement (LNI) risk \>5%.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 706 (estimated)
- First submitted
- 28 Jul 2021
- Start date
- 28 Jul 2021
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Canisius-Wilhelmina Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT05000827
What you commit to
- Study type: Interventional
- Planned participants: 706
- From 28 Jul 2021 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior diagnosed or treated PCa
- Known concomitant malignancies (except Basal Cell Carcinoma of the skin)
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Canisius Wilhelmina Ziekenhuis Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.