Status:
ACTIVE_NOT_RECRUITING
POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions
Lead Sponsor:
University of Florida
Conditions:
Prostate
Eligibility:
MALE
18-100 years
Phase:
PHASE2
Brief Summary
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 result...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2032
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07220720
Start Date
November 4 2025
End Date
November 15 2032
Last Update
November 6 2025
Active Locations (1)
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1
UF Health - Jacksonville
Jacksonville, Florida, United States, 32209