NCT06675357 · University of Wisconsin, Madison
Using FAPI PET/MRI to Evaluate Prostate Cancer
What this study is about
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.
View original scientific description
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
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).
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations