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

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer; Prostate Cancer Metastatic
• Interventions: Diagnostic Test: FAPI PET/CT

• Registration Number: NCT06634173
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-20
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Study Start: 2024-12-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FAPI PET/CT	FAPI PET/CT	Patients will undergo an additional diagnostic FAPI PET/CT scan within four weeks after PSMA PET/CT and within four weeks before planned treatment.

Primary Outcome Measures

Name	Time	Method
detection rates and target-to-background ratios of FAPI PET/CT in patients with hormone-sensitive PCa.	within four weeks after PSMA PET/CT and within four weeks before planned treatment.

Secondary Outcome Measures

Name	Time	Method
Diagnostic value of FAPI PET/CT, relative to PSMA PET/CT, in staging of newly diagnosed PCa	within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Correlate histopathological findings after robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND) to FAPI PET/CT findings to determine its diagnostic accuracy for staging of newly diagnosed PCa.	within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Correlate laboratory parameters (prostate specific antigen (PSA) levels) after treatment to FAPI PET/CT findings to determine its diagnostic accuracy.	within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Obtain preliminary data on the FAP overexpression in primary prostate tumor and lymph node metastases by immunohistochemical staining.	within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Correlate immunohistochemical staining with FAPI uptake measured on PET/CT	within four weeks after PSMA PET/CT and within four weeks before planned treatment.