Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Evaluating prostate cancer using FAPI PET/MRI scans

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

Run by University of Wisconsin, Madison · NCT06675357 · Data updated 2026-11-12

This study is testing if a special type of scan can help doctors better diagnose and monitor prostate cancer in patients who already have the disease.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorUniversity of Wisconsin, Madison
Academic / other
Locations1 site (Madison, Wisconsin)
StatusRecruiting
StartedFebruary 27, 2026
Main results expectedJanuary 2027
Study endsJanuary 2027
Registry record updatedJune 10, 2026
Trial IDNCT06675357 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with a known diagnosis of prostate cancer and established or suspected non-osseous, non-nodal metastases.

Probably not a fit

Patients who are unable to undergo PET/MRI or those whose treatment would be delayed by participation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to investigate how FAPI (fibroblast activation protein inhibitor) binds to specific cells in tumor tissue to enhance the diagnosis and monitoring of prostate cancer. Participants will undergo two PET/MRI scans during separate research visits, each lasting up to 2.5 hours. The study focuses on patients with known prostate cancer and aims to gather data on non-osseous, non-nodal metastases to improve clinical outcomes.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnosis and tracking of prostate cancer, potentially improving patient management.

How similar studies have gone: While this approach is innovative, similar studies using advanced imaging techniques have shown promise in improving cancer diagnostics.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of Wisconsin
    Madison, Wisconsin, United States
    Recruiting

Study contacts

  • Principal investigator: Ali Pirasteh, MD — University of Wisconsin, Madison
  • Study coordinator: Radiology Studies
  • Email: Radstudy@uwhealth.org
  • Phone: 608-282-8349

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.