Using POSLUMA4 18F-rhPSMA-7.3 PET-CT to Improve Detection of Significant Prostate Cancer in Men with PIRADS 2 or 3 MRI Lesions

What this Trial Is About

Researchers are evaluating whether the 18F-rhPSMA-7.3 PET-CT scan, also known as POSLUMA, can better detect significant prostate cancer in men who have uncertain MRI results showing PIRADS 2 or 3 lesions. The study aims to find out if this new imaging test improves detection compared to the standard MRI-based biopsy approach. This trial is a Phase 2 interventional study sponsored by the University of Florida. Participants will receive a single infusion of the PSMA-targeted PET imaging agent called Flotufolastat F 18, followed by a POSLUMA PET scan to locate prostate cancer. The study focuses on men who are scheduled for a targeted MRIultrasound biopsy based on recent pelvic multiparametric MRI findings. This imaging agent is administered one time per participant to assess its diagnostic accuracy. During the study, researchers will measure changes in the positive and negative predictive values and overall accuracy of prostate cancer detection from enrollment to about 12 weeks later at the end of treatment visit. Participants will have imaging and biopsy procedures as scheduled, and the study will monitor how well the PET scan detects clinically significant prostate cancer. The total participation time is roughly 12 weeks, with safety and diagnostic outcomes evaluated throughout this period.

POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions