Using FAPI PET/MRI to Evaluate Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FAPI, Positron Emission Tomography (PET), Magnetic Resonance Imaging.
- Who it may be relevant to
- Registry conditions: Prostate Cancer Metastatic Disease, Prostate Cancers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Novel FAP-targeted Approach to Imaging Patients With or High-risk for Metastatic Prostate Cancer
Overview
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.
Interventions
- Radiation FAPI
5 +/- 2 mCi of Ga-FAPI-46 - Procedure Positron Emission Tomography (PET)
Undergo PET scan - Procedure Magnetic Resonance Imaging
Undergo MRI scan
Primary outcome measures
- Performance of FAPI for lesion detection [Time frame: Duration of scan, up to 80 minutes]
- Lesion FAPI uptake on PET [Time frame: Duration of scan, up to 80 minutes]
- Total FAPI-positive tumor volume change [Time frame: Duration of scan, up to 80 minutes]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Wisconsin — Madison
Identifiers
NCT: NCT06675357 · 2024-0747 · A539300 · Protocol Version 8/4/25 · UW24045 · Prostate SPORE