Using FAPI PET/MRI to Evaluate Prostate Cancer

Phase 2

Recruiting

• Conditions: Prostate Cancer Metastatic Disease; Prostate Cancers

• Registration Number: NCT06675357
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

The goal of this clinical trial is to gain more information about how FAPI (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. The main question it aims to answer is how this information can be used to better diagnose and track prostate cancer.

Participants will undergo two PET/MRI scans during two research visits, each of which may last up to 2.5 hours.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Study Start: 2025-05
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age 18 years or older
• Able and willing to provide informed consent
• Known diagnosis of prostate cancer with established or suspected non-osseous, non-nodal metastases
• Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET
• Optional: Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases.
• Willing and able to undergo PET/MRI as part of this research

Exclusion Criteria

• Unable or unwilling to provide informed consent
• Contraindication(s) to or inability to undergo PET/MRI
• Participants for whom PET/MRI will delay timely delivery of treatment
• Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
• Have their own prescription for the medication
• The informed consent process is conducted prior to the self-administration of this medication
• Come to the research visit with a driver

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Performance of FAPI for lesion detection	Duration of scan, up to 80 minutes	Sensitivity and specificity for lesion detection on FAPI will be compared with that of PSMA PET, using a composite reference standard (all available histology, follow up clinical/standard of care imaging, serum PSA).
Lesion FAPI uptake on PET	Duration of scan, up to 80 minutes	FAPI uptake as measured by SUV will be correlated against tissue FAP positivity on immunohistochemistry and FAP expression on qPCR, using linear regression.
Total FAPI-positive tumor volume change	Duration of scan, up to 80 minutes	The total FAPI-positive tumor volume between pre- and post-treatment exams will be measured and compared to PSMA-response, other standard-of-care imaging response, and overall survival when available, using odds ratios for treatment response and Kaplan-Meier curve for survival.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States