The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer

Inclusion Criteria: * Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician * Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4 * In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level. * Patients must be scheduled for biopsy or radical prostatectomy * Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study * Patients must be medically stable as judged by the patient's physician * Patients must be able to lie still for a total of 60 minutes for the PET/CT scans * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study * Patients who have had a prior biopsy for prostate cancer cannot participate in the study * Patients who have been treated for cancers other than skin cancers * Subjects may not be receiving any other investigational agents for the treatment of the cancer under study * Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (\>200 kilograms or 440 pounds) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI * Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies