NCT05000827 Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients
| NCT ID | NCT05000827 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Canisius-Wilhelmina Hospital |
| Condition | Prostate Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 706 participants |
| Start Date | 2021-07-28 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 706 participants in total. It began in 2021-07-28 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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%.
Eligibility 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)
Contact & Investigator
Jean-Paul A. van Basten
PRINCIPAL INVESTIGATOR
Canisius-Wilhelmina Hospital
Frequently Asked Questions
Who can join the NCT05000827 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05000827 currently recruiting?
Yes, NCT05000827 is actively recruiting participants. Contact the research team at l.wever@antoniusziekenhuis.nl for enrollment information.
Where is the NCT05000827 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT05000827 clinical trial?
NCT05000827 is sponsored by Canisius-Wilhelmina Hospital. The principal investigator is Jean-Paul A. van Basten at Canisius-Wilhelmina Hospital. The trial plans to enroll 706 participants.
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