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Evaluating Prostate Cancer with FAPI PET/MRI

This study is looking at how a special imaging agent called FAPI (fibroblast activation protein inhibitor) can help doctors better diagnose and track prostate cancer. You might be able to join if you are 18 or older, have a known prostate cancer diagnosis, and have recently had or are scheduled for a standard PSMA PET scan. The researchers want to see how well FAPI helps find cancer spots and how much FAPI is taken up by these spots during a PET/MRI scan. They will also measure changes in the total volume of FAPI-positive tumors. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 30 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo two PET/MRI scans during two research visits, each lasting up to 2.5 hours.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, such as lesion detection and FAPI uptake, are measured during the scan, up to 80 minutes.

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NCT06675357

Using FAPI PET/MRI to Evaluate Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
University of Wisconsin, Madison
~30 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:FAPIPositron Emission Tomography (PET)Magnetic Resonance Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Performance of FAPI for lesion detection
Measured over Duration of scan, up to 80 minutes
+2 more outcomes measured

Conditions

Prostate Cancer Metastatic Disease
Prostate Cancers

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Ali Pirasteh, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Radiology Studies
[email protected]
608-282-8349
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Performance of FAPI for lesion detectionDuration 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 PETDuration 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 changeDuration 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.