Clinical Trial · NCT06634173

The Diagnostic Value of FAPI PET/CT in Staging of Newly Diagnosed Prostate Cancer

Overview

This study aims to investigate the diagnostic value of FAPI PET/CT, relative to standard-of-care imaging using PSMA PET/CT, in staging of newly diagnosed PCa. FAPI PET/CT will be visually and quantitatively correlated to PSMA PET/CT resulting in detection rates and target-to-background ratios. If available, histopathology of resected specimens will serve as reference test for operated patients in order to determine diagnostic accuracy. All outcomes are descriptive and serve as pilot for a potential subsequent larger prospective diagnostic study.

Sponsor

The Netherlands Cancer Institute

Phase

N/A

Contacts

Evelien Schouten, MSc (CONTACT)

ev.schouten@nki.nl

+3120-5129140

ClinicalTrials.gov

NCT06634173

Eligibility

Inclusion

Biopsy-proven newly diagnosed PCa;
Increased risk of nodal metastases according to the Briganti 2019 nomogram (Briganti ≥40%) \[22\];
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):
Scheduled for (laparoscopic) prostatectomy including ePLND.
PSMA PET/CT with PSMA-avid primary tumor with no PSMA-avid loco-regional or distant metastases;
WHO performance status 0, 1 or 2;

Exclusion

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.