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NCT Number: NCT06675357

Using FAPI PET/MRI to Evaluate 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.

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Key information

Conditions

Prostate Cancer Metastatic Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancers Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FAPI

Radiation

5 +/- 2 mCi of Ga-FAPI-46

Positron Emission Tomography (PET)

Procedure

Undergo PET scan

Magnetic Resonance Imaging

Procedure

Undergo MRI scan

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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