Actively Recruiting
Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients
Led by Canisius-Wilhelmina Hospital · Updated on 2025-02-21
706
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
C
Canisius-Wilhelmina Hospital
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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%.
CONDITIONS
Official Title
Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven adenocarcinoma of the prostate
- Indication for extended pelvic lymph node dissection combined with robot-assisted radical prostatectomy (nomogram risk >5%)
- Suitable for robot-assisted extended pelvic lymph node dissection and radical prostatectomy
- Mentally competent and understands the benefits and potential burdens of the study
- Provides written informed consent
- No known allergies to PSMA tracer
You will not qualify if you...
- History of prior diagnosed or treated prostate cancer
- Known other cancers except basal cell carcinoma of the skin
- Unwilling or unable to undergo PSMA PET/CT and/or extended pelvic lymph node dissection and radical prostatectomy
- Prostate cancer that does not show PSMA activity
- Presence of distant metastasis (M1)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands, 6532 SZ
Actively Recruiting
Research Team
L
Lieke Wever
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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