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FAPI PET/MRI for Prostate Cancer

Phase 2
Recruiting
Led By Ali Pirasteh, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of scan, up to 80 minutes
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to understand how a specific drug, FAPI, interacts with cells in tumor tissue to improve the diagnosis and monitoring of prostate cancer. Participants will have two imaging scans during two visits lasting up

Who is the study for?
This trial is for individuals with prostate cancer. Participants will be required to undergo two PET/MRI scans, each lasting up to 2.5 hours. The eligibility criteria are not fully listed but typically include specific health conditions and demographic factors.
What is being tested?
The study is testing the use of FAPI (fibroblast activation protein inhibitor) in combination with PET/MRI scanning technology to improve diagnosis and monitoring of prostate cancer by seeing how well FAPI binds to tumor cells.
What are the potential side effects?
Potential side effects are not detailed here, but generally, PET/MRI scans are considered safe. However, there may be risks associated with exposure to radiation from the PET scan and reactions to any contrast agents used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a biopsy of a suspected cancer spread that is not in bones or lymph nodes.
Select...
I am 18 years old or older.
Select...
I have prostate cancer that has spread beyond my bones and lymph nodes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of scan, up to 80 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of scan, up to 80 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Lesion FAPI uptake on PET
Performance of FAPI for lesion detection
Total FAPI-positive tumor volume change

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fibroblast activation protein inhibitor (FAPI)Experimental Treatment3 Interventions
FAPI radiotracer will be used during PET
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Positron Emission Tomography (PET)
2018
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,232 Previous Clinical Trials
3,200,011 Total Patients Enrolled
34 Trials studying Prostate Cancer
8,960 Patients Enrolled for Prostate Cancer
Ali Pirasteh, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
~20 spots leftby Oct 2026
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