POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions
Recruiting · NCT07220720 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Florida
View the official record on ClinicalTrials.gov →Interventions studied
Flotufolastat F 18
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed across 1 US state.
- UF Health - Jacksonville - Jacksonville, Florida, United States