PSMA scan to guide lymph node surgery in newly diagnosed prostate cancer
Tests a PSMA scan to decide who needs lymph node removal.
Plain-language title generated from the registry record
Registry title: Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients
Key facts
- Where
- Nijmegen, NetherlandsSee the site
Where in Netherlands
- Canisius Wilhelmina ZiekenhuisNijmegen, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Canisius-Wilhelmina Hospital
- Trial code
- NCT05000827
- Record updated
- 21 February 2025
- Original description
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%.Read full original descriptionShow less
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
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%.
Inclusion: 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: 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).