68GA-PSMA Fusion PET/MRI in Diagnosing Patients with Prostate Cancer

Inclusion Criteria

• Prior mpMRI (within 3 months of recruitment) resulting in at least one Prostate Imaging Reporting and Data System (PI-RADS) 3-5 lesion with clinical need for a prostate biopsy procedure can participate, if one of the 2 criteria apply: * Known Gleason 6 (3+3) or 7 (3+4, 4+3) prostate cancer undergoing active surveillance or in the confirmation phase of active surveillance, or * Rising prostate specific antigen (PSA) with either a) no prior biopsy or b) single or multiple negative prior biopsies
• Subjects who received a 68Ga-PSMA PET/CT and subsequent (clinical) TRUS-guided targeted biopsy, and are again in clinical need of a prostate biopsy can again take part in the study to receive a second 68Ga-PSMA PET/CT scan, however not earlier than 12 months after the prior 68Ga-PSMA PET/CT scan.

Exclusion Criteria

• Prostate biopsy within 12 weeks prior to enrollment.
• Acute prostatitis within the last 6 months.
• Current non-urologic bacterial infection requiring active treatment with antibiotics.
• Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years.
• Body weight greater than 350 lbs (158 Kg).
• Inability or unwillingness to receive a prostate biopsy procedure.
• Unable to lie flat, still, or tolerate a PET/CT scan.
• Unable to provide own consent.
• Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).
• Prisoner.