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

Netherlands Cancer Institute (NKI)

Status

Not yet enrolling

Conditions

Prostate Cancer Metastatic

Prostate Cancer

Treatments

Diagnostic Test: FAPI PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT06634173

M22PFI

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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%) [22];
Scheduled for (laparoscopic) prostatectomy including ePLND.

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.