Prostate, Prostate Adenocarcinoma, Prostate Cancer
Conditions
Brief summary
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.
Interventions
PSMA-11 Ga 68 Injection is a positron emitting radiopharmaceutical containing radioactive 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (PSMA-11), which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET).
A PET scan is an imaging test that helps reveal how your tissues and organs are functioning using a radioactive drug (tracer) to show this activity
Sponsors
Eligibility
Inclusion criteria
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
Countries
United States