Using FAPI PET/MRI to Evaluate Prostate Cancer

NCT ID: NCT06675357

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Metastatic Disease Prostate Cancers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fibroblast activation protein inhibitor (FAPI)

FAPI radiotracer will be used during PET

Group Type EXPERIMENTAL

Positron Emission Tomography (PET)

Intervention Type PROCEDURE

Undergo PET scan

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI scan

FAPI

Intervention Type RADIATION

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

Interventions

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Positron Emission Tomography (PET)

Undergo PET scan

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MRI scan

Intervention Type PROCEDURE

FAPI

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Pirasteh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Radiology Studies

Role: CONTACT

608-282-8349

Other Identifiers

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A539300

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 8/4/25

Identifier Type: OTHER

Identifier Source: secondary_id

UW24045

Identifier Type: OTHER

Identifier Source: secondary_id

Prostate SPORE

Identifier Type: OTHER

Identifier Source: secondary_id

2024-0747

Identifier Type: -

Identifier Source: org_study_id

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