Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Prostate-specific membrane antigen (PSMA) is a transmembrane surface protein highly overexpressed in over 90% of prostate cancer lesions.⁶⁸Ga-NYM032 Injection, a PSMA-targeted radiotracer, is indicated for PET/CT imaging in patients with prostate cancer. Patients will receive 68Ga-NYM032 imaging to identify pelvic lymph node involvement.

Inclusion criteria

• Patient is male and aged >18 years old.
• Biopsy proven prostate adenocarcinoma.
• Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
• ECOG performance status 0-2; expected survival ≥ 6 months.

• Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

• 1. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection.

• Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.

• Known hypersensitivity to the active ingredient or excipients of the study drug.

• Participants not capable of getting PET study , or inability to lay still for the duration of the exam.

• Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.