Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer

Expanded Access: 68Gallium-PSMA-11 for PET Imaging of Prostate Cancer

This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.

Biochemical recurrent and pre-prostatectomy staging participants will be eligible and must meet the following criteria:

Inclusion Criteria:

1. Age ≥ 18 years

2. Histopathologically confirmed or biopsy proven prostate adenocarcinoma.

3. Concern for metastatic disease in one of the following settings:

   1. Initial staging with intermediate to high risk prostate cancer.
   2. Biochemical recurrence after initial therapy.

4. Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation