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

Summary

The investigators are imaging patients with newly diagnosed prostate cancer using a new Positron Emission Tomography (PET) imaging agent (68Ga-NYM032) in order to evaluate the safety and diagnostic performance.

Eligibility

Inclusion Criteria:

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

6\. 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.

Conditions2

Interventions1

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