Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

Inclusion Criteria:

• Patients with histologically proven prostate adenocarcinoma.

• Prior radical prostatectomy (greater than 6 weeks prior to screening) or radiationtherapy (greater than 1 year prior to screening) with curative intent.

• Recurrence of disease defined as:

1. Prior radical prostatectomy: PSA greater than or equal to 0.2 ng/mL followed bysubsequent confirmatory PSA value greater than or equal to 0.2 ng/mL or

2. Prior radiation therapy: 2 ng/mL rise in PSA over post-treatment nadir.

• Male aged greater than or equal to 18 years.

• Able to understand and provide signed written informed consent.

Exclusion Criteria:

• Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathwaywithin the past 3 months. Patients with a rising PSA level while on ADT for greaterthan 6 months are eligible.

• 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 scan) 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.