Using FAPI PET/MRI to Evaluate Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Have their own prescription for the medication
Trial design
Design model
Single group
Treatments tested in this trial
FAPI
Radiation5 +/- 2 mCi of Ga-FAPI-46
Positron Emission Tomography (PET)
Procedure/SurgeryUndergo PET scan
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI scan
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Fibroblast activation protein inhibitor (FAPI)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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 minutes2
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 minutes3
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 minutesSponsors and contacts
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Source ClinicalTrials.gov