A Phase 2 interventional study of FAPI and Positron Emission Tomography (PET) in Prostate Cancer Metastatic Disease and Prostate Cancers, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Diagnostic
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 30 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FAPI radiotracer will be used during PET
Radiation: FAPI · Procedure: Positron Emission Tomography (PET) · Procedure: Magnetic Resonance Imaging
5 +/- 2 mCi of Ga-FAPI-46
Undergo PET scan
Undergo MRI scan
Performance of FAPI for lesion detection
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).
Time frame: Duration of scan, up to 80 minutes
Lesion FAPI uptake on PET
FAPI uptake as measured by SUV will be correlated against tissue FAP positivity on immunohistochemistry and FAP expression on qPCR, using linear regression.
Time frame: Duration of scan, up to 80 minutes
Total FAPI-positive tumor volume change
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.
Time frame: Duration of scan, up to 80 minutes
Plan to share: Yes — De-identified data with GE Healthcare: images, diagnosis, image quality scores, quantitative PET/MR measurements, BMI, weight, height, age and gender. The Department of Radiology Medical Imaging Research Support (MIRS) Radius team will serve as an honest broker for the sharing of de-identified data.
No publications or documents are linked to this record.
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University of Wisconsin, Madison