Gozetotide for Prostate cancer

Inclusion criteria

• {"criterion_text":"- 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 criteria

• {"criterion_text":"- 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)"}

Primary endpoints

• {"endpoint_text":"- Biochemical recurrence rate within two years after surgery, defined as a PSA > 0.2 ng/ml.","definition_or_measurement_approach":"Defined as a PSA > 0.2 ng/ml measured within two years after surgery."}

Secondary endpoints

• {"endpoint_text":"- 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.\n- Biochemical persistence, defined as PSA >0.1 within half a year after surgery\n- Surgical complications within 6 months after surgery.\n- Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template.\n- The necessity for a second PSMA PET / CT.","definition_or_measurement_approach":"1) Count and health-economic evaluation of performed ePLNDs and PSMA PET/CTs and associated intervention-related costs and prolonged hospital stay (method not further specified).\n2) Biochemical persistence: defined as PSA >0.1 within half a year after surgery.\n3) Surgical complications: recorded within 6 months after surgery.\n4) Total number of nodes resected and number positive/negative within and outside standard ePLND template (counts from pathology reports).\n5) Necessity for a second PSMA PET/CT (recorded as occurrence/count)."}

Netherlands

Earliest CTIS Part Ii Submission Date

13-12-2024

Latest Decision Or Authorization Date

23-01-2025

Processing Time Days

41

Number Of Sites

17

Number Of Participants

742

Primary sponsor

Full Name

Canisius Wilhelmina Ziekenhuis

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"NOVARTIS EUROPHARM LIMITED","duties_or_roles":"Marketing authorisation holder for Locametz (kit for radiopharmaceutical preparation) as listed in product information","organisation_type":"Pharmaceutical company"}