A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA IT PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical

The purpose of this research study is to see how safe and effective the use of copper Cu 64 PSMA I&T Injection is in imaging prostate cancer tumors for staging of men with newly diagnosed intermediate or high risk prostate cancer. Copper Cu 64 PSMA I&T Injection is an investigational imaging agent, given to you through your vein (intravenous (IV)), that makes tumors from prostate cancer show up during a nuclear medicine imaging scan. The imaging scan is a type of nuclear medicine imaging test, which means it uses a radioactive drug (a drug that contains a radioactive substance and is used to diagnose or treat disease, including cancer) and a special camera to create pictures of your tumor(s). Copper Cu 64 PSMA I&T Injection is investigational in the United States which means that the U.S. Food and Drug Administration (FDA) has not approved it for use in anything other than research studies.

Are you Eligible? (Inclusion Criteria)

• Must be 18 years old or older - Must be able to understand and provide signed written informed consent - Must not had a PSMA PET as part of the standard medical care within 90 days prior to enrollment