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

Prior treatment

• Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy.
• Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.
• Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET study) that the investigator believes may compromise the data 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 PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan.
• Patients who are administered any high energy (greater than 300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\&T administration.
• Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.

Other illness

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

• 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 NCCN Guidelines Version 1.2023 and previous versions.
• Male aged greater than or equal to 18 years.
• Able to understand and provide signed written informed consent.