Inclusion Criteria:

• Patients with high risk prostate cancer may be evaluated with whole body [Ga-68] PSMA-11 PET/CT or PET/MRI in order to determine the presence of local and distant metastases, and to differentiate between oligometastatic disease versus wide-spread metastases, ultimately guiding selection of initial anti-cancer treatment strategy.
• Patients with prostate cancer, who have not received anticancer therapy and who meet at least one of the following criteria for high-risk prostate cancer are eligible for inclusion in this expanded access IND study:
  • Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more.
• Pathologic criteria of International Society of Uropathology (ISUP) grade group 3–5:
  • ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10.
• Local staging of T3 or worse, indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI.

Exclusion Criteria:

• Those patients with untreated high-risk prostate cancer who may or may not be excluded from access to [Ga-68] PSMA-11 PET include:
  • Patients who have clear evidence for distant metastases on imaging and/or biopsy;
  • Patients who have suspected metastases on imaging;
  • Patients who have not undergone a bone scan plus either CT or MRI;
  • Patients who have not undergone a prostate MRI;
  • Patients who have Gleason 4+3 pathology;
  • Patients who have Gleason 4+3 or 8 pathology;
  • Patients who are known to have PSMA negative tumors by histology;
  • Patients who have a PSA doubling time > 12 months;
  • Patients who have at least one other type of active cancer (not including non-melanoma skin cancer);
  • Patients with dementia;
  • Patients which a life expectancy less than 6 months.