Prostate cancer
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Male, aged >= 18 years; - WHO performance status 0, 1 or 2; - Written informed consent; - Biopsy-proven newly diagnosed PCa; - International Society of Urological Pathology (ISUP) grade group (GG) >= 3 and/or PSA >= 20 ng/ml and/or >=cT3a. If all of the criteria above are met, a subject must also meet all of the following subgroup specific criteria: Group 1 (n=15): - PSMA PET/CT with PSMA-avid primary tumor with PSMA-avid loco-regional and/or distant metastases. Group 2 (n=15): - PSMA PET/CT with PSMA-avid primary tumor with no PSMA-avid loco-regional or distant metastases; - Increased risk of nodal metastases according to the Briganti 2019 nomogram (Briganti >=40%) - Scheduled for (laparoscopic) prostatectomy including ePLND.
Exclusion criteria
Exclusion criteria: - Known second malignant disease that may complicate image interpretation. - Inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The added diagnostic value of FAPI PET/CT, relative to PSMA PET/CT, in staging of newly diagnosed PCa. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: the diagnostic accuracy of FAPI PET/CT by correlating FAPI PET/CT findings to clinical follow-up and histopathological and/or laboratory findings. | — |
Countries
Netherlands
Outcome results
None listed