Beacon Trial Using Flotufolastat F 18 PSMA PETCT and MRI to Improve Detection of Significant Prostate Cancer in Men

What this Trial Is About

Researchers are evaluating a new imaging technique using flotufolastat F 18, a radioactive agent that binds to prostate cancer cells expressing prostate specific membrane antigen PSMA, combined with PETCT scans. This early phase I trial compares this method to conventional MRI-guided prostate biopsies in men with prostate cancer. The goal is to see if PSMA PETCT can better guide targeted biopsies to detect clinically significant prostate cancer and improve risk assessment and management. Participants receive an intravenous dose of flotufolastat F-18, followed by a 30-minute PETCT scan 50 to 100 minutes later. Within six months of imaging, they undergo two types of biopsies in random order one guided by PSMA PETCT fused with ultrasound, and another guided by MRI fused with ultrasound. Blood samples may be collected at screening and during the study. After the biopsy procedures, participants are followed up within 3 months and then annually for up to 10 years. During the study, researchers assess detection rates of high-grade prostate cancer grade group 2 or higher and evaluate incidental detection of low-grade cancer. They compare tumor locations identified by MRI and PSMA methods and validate combined MRI and PSMA PET scores. Participants will have imaging, biopsies, and blood tests along with long-term follow-up to monitor outcomes and safety. The study lasts up to 10 years post-biopsy for ongoing assessment.

Comparing a New PSMA Imaging Agent to MRI for Detecting Prostate Cancer, BEACON Trial