2024-518171-59-00Active, not recruitingPhase 4
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 (PSMA-SELECT).
Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Jul 2025
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 pelvic 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 (non-inferior) 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)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 742 (estimated)
- First submitted
- 23 Nov 2024
- Start date
- 23 Jan 2025
- Lead sponsor
- Canisius Wilhelmina Ziekenhuis
- Diseases
- Prostate cancer
- EU CT number
- 2024-518171-59-00
- EudraCT number
- 2021-002055-12
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 742
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. History of prior diagnosed or treated PCa 2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin) 3.Unwillingness or inability to undergo PSMA PET/CT and/or ePLND 4. PSMA non-avid PCa (local tumor activity) 5. Presence of distant metastasis (M1)
Who the study is looking for
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Age ≥18 years 2. Biopsy proven adenocarcinoma of the prostate 3. Indication for ePLND combined with RARP 4. Suitable for robot-assisted ePLND + RARP 5.. Mentally competent and understanding of benefits and potential burden of the study 6. Written informed consent
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuisgroep Twente Stichting | Almelo | Netherlands | Active, not recruiting |
| Meander Medisch Centrum | Amersfoort | Netherlands | Active, not recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting | Amsterdam | Netherlands | Active, not recruiting |
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Active, not recruiting |
| Rijnstate Ziekenhuis Stichting | Arnhem | Netherlands | Active, not recruiting |
| Amphia Hospital | Breda | Netherlands | Active, not recruiting |
| Reinier de Graaf Groep | Delft | Netherlands | Active, not recruiting |
| Catharina Ziekenhuis Stichting | Eindhoven | Netherlands | Active, not recruiting |
| Máxima Medisch Centrum | Eindhoven | Netherlands | Active, not recruiting |
| Zuyderland Medisch Centrum Stichting | Heerlen | Netherlands | Active, not recruiting |
| Medisch Centrum Leeuwarden B.V. | Leeuwarden | Netherlands | Active, not recruiting |
| Sint Antonius Ziekenhuis Stichting | Nieuwegein | Netherlands | Active, not recruiting |
| Canisius Wilhelmina Ziekenhuis | Nijmegen | Netherlands | Active, not recruiting |
| Bravis Ziekenhuis | Roosendaal | Netherlands | Active, not recruiting |
| Maasstad Ziekenhuis Stichting | Rotterdam | Netherlands | Active, not recruiting |
| Jeroen Bosch Ziekenhuis Stichting | 'S-Hertogenbosch | Netherlands | Active, not recruiting |
| Isala Klinieken Stichting | Zwolle | Netherlands | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.