What this study is
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.
What's being tested
- Flotufolastat F 18
Intervention · DRUG
A PSMA-targeted PET imaging agent used to detect and locate prostate cancer during PET scans that will be administered one time to each study subject.
Study details
- Official title
- Inclusion of POSLUMA® ((18)F-rhPSMA-7.3) PET-CT Imaging Improves Diagnostic Accuracy of Clinically-Significant Prostate Cancer Diagnosis in Men With PIRADS 2 and 3 Lesions on MRI
- Sponsor
- University of Florida
- Conditions
- Prostate
- Enrolling
- 30 people
- Starts
- 2025-11-04
- Est. completion
- 2032-11-15
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex MALEHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUF Health - Jacksonville
Jacksonville, Florida, United States
Study team
Sponsor
University of Florida
Study ID IRB202401666
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.