This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer.

A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Safety of 68Ga-NYM032 Injection PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer

This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET/CT imaging in patients with suspected recurrence of 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. Patients with suspected metastatic prostate cancer will undergo imaging with ⁶⁸Ga NYM032 Injection, a PSMA targeted radiotracer.

Inclusion Criteria:

1. Patient is male and aged >18 years old.

2. Participants with histopathologically confirmed prostate adenocarcinoma, who present with elevated PSA and suspected recurrence following radical prostatectomy and/or radiotherapy and/or other radical prostate cancer treatments (e.g., proton therapy, cryoablation, high-intensity focused ultrasound, etc.). (PSA must be measured within 30 days prior to screening.). (Meeting any one of the following criteria):

   1. Post-radical prostatectomy (RP): PSA ≥0.2 ng/mL on two consecutive measurements obtained ≥6 weeks after surgery;
   2. Post-radiotherapy (as defined by the ASTRO-Phoenix consensus): PSA rise ≥2 ng/mL above the PSA nadir;
   3. Participants with recurrence after other treatments: PSA rise ≥2 ng/mL above the PSA nadir.

3. ECOG performance status 0-2; expected survival ≥ 6 months.

4. 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.
2. 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.
3. Known hypersensitivity to the active ingredient or excipients of the study drug.
4. Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
5. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.