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).
Key facts
- Where
- 'S-Hertogenbosch, Almelo, Amersfoort, Amsterdam, Arnhem, Breda, Delft, Eindhoven, Heerlen, Leeuwarden, Nieuwegein, Nijmegen, Roosendaal, Rotterdam és Zwolle, HollandiaSee the 17 sites
- Phase
- 4. fázis
Where in Hollandia
- Jeroen Bosch Ziekenhuis Stichting'S-Hertogenbosch, HollandiaNo longer taking part
- Ziekenhuisgroep Twente StichtingAlmelo, HollandiaNo longer taking part
- Meander Medisch CentrumAmersfoort, HollandiaNo longer taking part
- Amsterdam UMC StichtingAmsterdam, HollandiaNo longer taking part
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, HollandiaNo longer taking part
- Rijnstate Ziekenhuis StichtingArnhem, HollandiaNo longer taking part
- Amphia HospitalBreda, HollandiaNo longer taking part
- Reinier de Graaf GroepDelft, HollandiaNo longer taking part
- Catharina Ziekenhuis StichtingEindhoven, HollandiaNo longer taking part
- Máxima Medisch CentrumEindhoven, HollandiaNo longer taking part
- Zuyderland Medisch Centrum StichtingHeerlen, HollandiaNo longer taking part
- Medisch Centrum Leeuwarden B.V.Leeuwarden, HollandiaNo longer taking part
- Sint Antonius Ziekenhuis StichtingNieuwegein, HollandiaNo longer taking part
- Canisius Wilhelmina ZiekenhuisNijmegen, HollandiaNo longer taking part
- Bravis ZiekenhuisRoosendaal, HollandiaNo longer taking part
- Maasstad Ziekenhuis StichtingRotterdam, HollandiaNo longer taking part
- Isala Klinieken StichtingZwolle, HollandiaNo longer taking part
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 Ziekenhuis
- Trial code
- EU 2024-518171-59-00
- Record updated
- 2025. július 31.
- 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 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%.Read full original descriptionShow less
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%.
Inclusion: 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.
Exclusion: 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).