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.
