Prostate Cancer Metastatic study: PSMA-PET/CT vs Nomogram
Official title Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients
ClinicalTrials.gov ID: NCT05000827
What this study is testing
- What it's testing
- to find out 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%.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Suitable for robot-assisted ePLND and RARP
- Mentally competent and understanding of benefits and potential burden of the study
- Written informed consent
You likely can't join if
- 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)
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Nijmegen, Gelderland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nijmegen, Gelderland, Netherlands. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.