Prostate Cancer Metastatic Disease, Prostate Cancers
Conditions
Brief summary
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
RADIATIONFAPI
5 +/- 2 mCi of Ga-FAPI-46
PROCEDUREPositron Emission Tomography (PET)
Undergo PET scan
PROCEDUREMagnetic Resonance Imaging
Undergo MRI scan
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of FAPI for lesion detection | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTRadiology Studies
PRINCIPAL_INVESTIGATORAli Pirasteh, MD
University of Wisconsin, Madison
Outcome results
None listed