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Recruiting Phase 2 NCT06675357

NCT06675357 Using FAPI PET/MRI to Evaluate Prostate Cancer

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Clinical Trial Summary
NCT ID NCT06675357
Status Recruiting
Phase Phase 2
Sponsor University of Wisconsin, Madison
Condition Prostate Cancer Metastatic Disease
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2026-02-27
Primary Completion 2027-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
FAPIPositron Emission Tomography (PET)Magnetic Resonance Imaging

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 30 participants in total. It began in 2026-02-27 with a primary completion date of 2027-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility 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

Contact & Investigator

Central Contact

Radiology Studies

✉ Radstudy@uwhealth.org

📞 608-282-8349

Principal Investigator

Ali Pirasteh, MD

PRINCIPAL INVESTIGATOR

University of Wisconsin, Madison

Frequently Asked Questions

Who can join the NCT06675357 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Prostate Cancer Metastatic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06675357 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT06675357 currently recruiting?

Yes, NCT06675357 is actively recruiting participants. Contact the research team at Radstudy@uwhealth.org for enrollment information.

Where is the NCT06675357 trial being conducted?

This trial is being conducted at Madison, United States.

Who is sponsoring the NCT06675357 clinical trial?

NCT06675357 is sponsored by University of Wisconsin, Madison. The principal investigator is Ali Pirasteh, MD at University of Wisconsin, Madison. The trial plans to enroll 30 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: September 2026  ·  Data Methodology