Using FAPI PET/MRI to Evaluate Prostate Cancer

June 9, 2026 updated by: University of Wisconsin, Madison

Novel FAP-targeted Approach to Imaging Patients With or High-risk for Metastatic Prostate Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin
        • Sub-Investigator:
          • Glenn Liu, MD
        • Principal Investigator:
          • Ali Pirasteh, MD
        • Sub-Investigator:
          • Joshua Lang, PhD
        • Sub-Investigator:
          • Diego Hernando, PhD
        • Sub-Investigator:
          • Steven Cho, MD, PhD
        • Sub-Investigator:
          • Alan McMillan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Able and willing to provide informed consent
  • Known diagnosis of prostate cancer
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fibroblast activation protein inhibitor (FAPI)
FAPI radiotracer will be used during PET
Procedure: Magnetic Resonance Imaging
Undergo MRI scan
Radiation: FAPI
5 +/- 2 mCi of Ga-FAPI-46
Procedure: Positron Emission Tomography (PET)
Undergo PET scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of FAPI for lesion detection
Time Frame: 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).
Duration of scan, up to 80 minutes
Lesion FAPI uptake on PET
Time Frame: 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.
Duration of scan, up to 80 minutes
Total FAPI-positive tumor volume change
Time Frame: 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.
Duration of scan, up to 80 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Ali Pirasteh, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0747
  • A539300 (Other Identifier: UW Madison)
  • UW24045 (Other Identifier: UWCCC OnCore ID)
  • Prostate SPORE (Other Identifier: UW Madison)
  • Protocol Version 8/4/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data with GE Healthcare: images, diagnosis, image quality scores, quantitative PET/MR measurements, BMI, weight, height, age and gender. The Department of Radiology Medical Imaging Research Support (MIRS) Radius team will serve as an honest broker for the sharing of de-identified data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer Metastatic Disease

Clinical Trials on Magnetic Resonance Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe