Evaluating prostate cancer using FAPI PET/MRI scans
Novel FAP-targeted Approach to Imaging Patients With or High-risk for Metastatic Prostate Cancer
This study is testing if a special type of scan can help doctors better diagnose and monitor prostate cancer in patients who already have the disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06675357 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate how FAPI (fibroblast activation protein inhibitor) binds to specific cells in tumor tissue to enhance the diagnosis and monitoring of prostate cancer. Participants will undergo two PET/MRI scans during separate research visits, each lasting up to 2.5 hours. The study focuses on patients with known prostate cancer and aims to gather data on non-osseous, non-nodal metastases to improve clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a known diagnosis of prostate cancer and established or suspected non-osseous, non-nodal metastases.
Not a fit: Patients who are unable to undergo PET/MRI or those whose treatment would be delayed by participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnosis and tracking of prostate cancer, potentially improving patient management.
How similar studies have performed: While this approach is innovative, similar studies using advanced imaging techniques have shown promise in improving cancer diagnostics.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madison, Wisconsin
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Ali Pirasteh, MD — University of Wisconsin, Madison
- Study coordinator: Radiology Studies
- Email: Radstudy@uwhealth.org
- Phone: 608-282-8349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.