POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions
Recruiting now · Phase 2
Conditions studied: Prostate
In brief
The goal of this study to determine if using the (18)F-rhPSMA-7.3 PET-CT scan can improve the ability to spot serious prostate cancer in patients who have uncertain MRI results. These uncertain results include MRI results that showed a PIRADS 2 or PIRADS 3 area on the prostate. The investigators want to find out if this new test is better to detect prostate cancer than just doing a biopsy based on MRI alone.
Key facts
- Study ID
- NCT07220720
- Run by
- University of Florida
- People needed
- 30
- Starts
- 2025-11-04
- Expected to finish
- 2032-11-15
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- The patient is willing to provide signed informed consent and is able to comply with all required study-related procedures, where safe and feasible.
- The patient is male and at least 18 years of age.
- The patient has not previously undergone a prostate biopsy.
- The patient underwent a pelvic mpMRI within the last 90 days for the detection of potential prostate cancer (Pca).
- The patient is a candidate for a targeted MRI/US biopsy and is scheduled to undergo the procedure. Only patients scheduled for a biopsy before recruitment will be considered candidates.
- The patient has PIRADS 2 and/or PIRADS 3 lesions detected by a board-certified radiologist.
You may not qualify if…
- Patients with a prior diagnosis of prostate cancer.
- Patients with any medical condition or circumstance that, in the investigator's opinion, could compromise the study data or prevent the patient from fulfilling the study requirements.
- Patients participating in another interventional clinical trial within the past 30 days.
- Patients with known hypersensitivity to the active substance or any excipients of flotufolastat F 18 PET-CT.
Where it is running
- UF Health - Jacksonville — Jacksonville, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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