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).
- Conditions
- Prostate Cancer
- Registration Number
- 2024-518171-59-00
- Lead Sponsor
- Canisius Wilhelmina Ziekenhuis
- Brief Summary
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%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Male
- Target Recruitment
- 742
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
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemical recurrence rate within two years after surgery, defined as a PSA > 0.2 ng/ml. Biochemical recurrence rate within two years after surgery, defined as a PSA > 0.2 ng/ml.
- Secondary Outcome Measures
Name Time Method - Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs, costs of complication-related interventions and associated (prolonged) hospital stay. - Biochemical persistence, defined as PSA >0.1 within half a year after surgery - Surgical complications within 6 months after surgery. - Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template. The necessity for a second PSMA PET / CT. - Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs, costs of complication-related interventions and associated (prolonged) hospital stay. - Biochemical persistence, defined as PSA >0.1 within half a year after surgery - Surgical complications within 6 months after surgery. - Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template. The necessity for a second PSMA PET / CT.
Trial Locations
- Locations (17)
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
🇳🇱Amsterdam, Netherlands
Catharina Ziekenhuis Stichting
🇳🇱Eindhoven, Netherlands
Isala Klinieken Stichting
🇳🇱Zwolle, Netherlands
Rijnstate Ziekenhuis Stichting
🇳🇱Arnhem, Netherlands
Maasstad Ziekenhuis Stichting
🇳🇱Rotterdam, Netherlands
Reinier de Graaf Groep
🇳🇱Delft, Netherlands
Amsterdam UMC Stichting
🇳🇱Amsterdam, Netherlands
Jeroen Bosch Ziekenhuis Stichting
🇳🇱'S-Hertogenbosch, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
Zuyderland Medisch Centrum Stichting
🇳🇱Heerlen, Netherlands
Scroll for more (7 remaining)Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting🇳🇱Amsterdam, NetherlandsPim van LeeuwenSite contact+31205121139pj.v.leeuwen@nki.nl