Elevated PSA

This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).

This is an investigator initiated study to test the efficacy of an upright MRI (Magnetic Resonance Imaging) for the screening of prostate cancer. The purpose of this study is to compare Upright MRI as a technique to PSA (Prostate Specific Antigen) and current MRI imaging. It will take place at Mount Sinai Hospital, and last for a total of about 5 years. Eligible patients will be determined by the urologist. The target population is men who are at risk for prostate cancer, as determined by the urologist. Diagnostic criteria will include elevated PSA and an abnormal digital rectal exam (DRE). After patients are screened and determined eligible, they will be asked to have a seated MRI using the Indomitable Magnetic Resonance Imaging Scanner, Ex vivo magnetic resonance imaging using 0.6 T strength, as well as a standard of care closed 3T MRI. After each scan, the patient will be given a series of questionnaires to assess their comfort level during the scan. Patients will be followed every 6 months after completion of (or early withdrawal from) study enrollment until 5 years.