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| ID | Type | Description | Link |
|---|---|---|---|
| A539300 | Other Identifier | UW Madison | |
| Protocol Version 8/4/25 | Other Identifier | UW Madison | |
| UW24045 | Other Identifier | UWCCC OnCore ID | |
| Prostate SPORE | Other Identifier | UW Madison |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibroblast activation protein inhibitor (FAPI) | Experimental | FAPI radiotracer will be used during PET |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAPI | Radiation | 5 +/- 2 mCi of Ga-FAPI-46 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | Duration of scan, up to 80 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radiology Studies | Contact | 608-282-8349 | Radstudy@uwhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Ali Pirasteh, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53705 | United States |
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.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Positron Emission Tomography (PET) |
| Procedure |
Undergo PET scan |
|
| Magnetic Resonance Imaging | Procedure | Undergo MRI scan |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |