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

This early phase I trial evaluates whether a new imaging technique using flotufolastat F 18 (a type of prostate specific membrane antigen \[PSMA\] imaging agent) with positron emission tomography (PET)/computed tomography (CT) can be used to guide targeted prostate biopsies in men with prostate cancer. Flotufolastat F 18 is a radioactive imaging agent that binds to prostate tumor cells that express PSMA. This allows for visualization of PSMA-expressing tumor cells on imaging scans such as PET/CT. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, flotufolastat F 18. Because prostate cancer takes up flotufolastat F 18, it can be seen with PET. CT utilizes X-rays that track the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. The PET/CT scanner combines the PET and the CT scanners into a single device. A targeted prostate biopsy refers to using advanced imaging for guidance when taking samples (biopsies) of the prostate. This method can fuse (combine) PET/CT images with real-time ultrasound during a prostate biopsy. PSMA PET/CT scans have the potential for guiding prostate biopsies. Using image fusion technology, they can increase detection of prostate cancer by providing anatomical information and guidance during a prostate biopsy. Improved detection of prostate cancer using PSMA PET/CT guidance may better inform men and their clinicians about prostate cancer risk and management. This study attempts to determine how often prostate cancer is found when using PSMA PET/CT scan images during a biopsy versus the conventional magnetic resonance imaging-guidance.

PRIMARY OBJECTIVE: I. To evaluate the detection rate of flotufolastat F 18 and magnetic resonance imaging (MRI) regions of interest for grade group 2 and greater prostate cancer. SECONDARY OBJECTIVES: I. Evaluate the detection rate of incidental grade group (GG)1 prostate cancer (region of interest \[ROI\] benign, systematic GG1). II. Evaluate the patient-level GG ≥ 2 detection rate for increasing standardized uptake value (SUV) and Prostate Imaging-Reporting and Data System (PI-RADS) score to determine if/when systematic biopsy may be omitted. III. Evaluate the concordance between biopsy methods for intraprostatic tumor location (e.g., right versus \[vs.\] left vs. bilateral). IV. Validate the MRI + prostate specific membrane antigen (PSMA)-positron emission tomography (PET) composite (P) score for prostate biopsy. EXPLORATORY OBJECTIVES: 1. Evaluate if MRI vs PSMA ROI detects more aggressive cancer clones based on the percentage of Gleason pattern 4 or 5. 2. Compare the tumor volume of PSMA and MRI for men proceeding to focal therapy. OUTLINE: Patients receive flotufolastat F-18 intravenously (IV) and then, 50-100 minutes later, undergo PET/CT over 30 minutes. Within 6 months of PET/CT imaging, patients undergo PSMA PET/CT/ultrasound (US) fusion biopsy and MRI/US fusion biopsy in a randomized order. Patients may undergo blood sample collection at screening and/or on study. After completion of study intervention, patients are followed up within 3 months of their biopsy and then every 12 months for up to 10 years.