An Investigational Scan (68Ga PSMA-11 PET/CT) for Enhancing the Diagnosis of Primary or 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 mp-MRI 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 kg or 440 pounds [lbs])
• 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 mp-MRI
• Prior transurethral prostatic resection (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies