Effect of Copper CU64 PSMA I&T scanning to detect potential disease spread to lymph nodes 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 PC prior to prostatectomy.
• Patients participating in an interventional clinical trial within 30 days and having received an IP within five (5) biological half-lives prior to administration.
• Patients with any medical condition or circumstance (including receiving an IP or capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfil 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 (>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 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 ≥18 years.
• Able to understand and provide signed written informed consent.