Using FAPI PET/MRI to Evaluate Prostate Cancer

University of Wisconsin (UW)

Status and phase

Enrolling

Phase 2

Conditions

Prostate Cancers

Prostate Cancer Metastatic Disease

Treatments

Procedure: Positron Emission Tomography (PET)

Radiation: FAPI

Procedure: Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT06675357

UW24045 (Other Identifier)

Protocol Version 8/4/25 (Other Identifier)

A539300 (Other Identifier)

Prostate SPORE (Other Identifier)

2024-0747

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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