Study Results
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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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2026-02-28
2027-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Fibroblast activation protein inhibitor (FAPI)
FAPI radiotracer will be used during PET
Positron Emission Tomography (PET)
Undergo PET scan
Magnetic Resonance Imaging
Undergo MRI scan
FAPI
5 +/- 2 mCi of Ga-FAPI-46
Interventions
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Positron Emission Tomography (PET)
Undergo PET scan
Magnetic Resonance Imaging
Undergo MRI scan
FAPI
5 +/- 2 mCi of Ga-FAPI-46
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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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