Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer

Inclusion Criteria:

• Patients with histologically proven prostate adenocarcinoma.

• Planned prostatectomy with pelvic lymph node dissection.

• Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCNGuidelines Version 1.2023 and previous versions.

• Male aged greater than or equal to 18 years.

• Able to understand and provide signed written informed consent.

Exclusion Criteria:

• Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (includinglocal ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy.

• Patients participating in an interventional clinical trial within 30 days and havingreceived an Investigational Product (IP) within five (5) biological half-lives priorto administration.

• Patients with any medical condition or circumstance (including receiving an IP ornot capable of having a PET study) that the investigator believes may compromise thedata collected or lead to a failure to fulfill the study requirements.

• Patients who are planned to have an x-ray contrast within 24 hours or other PETradiotracer within 10 physical half-lives prior to the PET scan. If Barium contrastis administered this should be cleared before the PET scan.

• Patients who are administered any high energy (greater than 300 KeV) gamma emittingradioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I&Tadministration.

• Patients with known hypersensitivity to the active substance or any of theexcipients of the IP.

• Patients who had a PSMA PET scan as part of their standard medical care within 90days prior to enrollment.