Testing 68Ga-NYM032 PET/CT in men with newly diagnosed prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 3 trial uses 68Ga-NYM032, a PSMA-targeted radiotracer, to perform PET/CT imaging in men with biopsy-confirmed prostate cancer who are electing radical prostatectomy with pelvic lymph node dissection. The goal is to evaluate safety and diagnostic performance in identifying cancer and nodal involvement to aid treatment planning. Participants receive the radiotracer and undergo PET/CT imaging to assess lesion detection and staging accuracy. Inclusion requires adults with ECOG 0-2 and expected survival of at least 6 months; key exclusions include prior radionuclide exposure within defined windows, iodinated or high-density contrast within specified times, and known hypersensitivity to the tracer. The study is sponsored by Norroy Bioscience Co., LTD with sites in Jiangsu, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Affiliated Drum Tower Hospital, Medical School of Nanjing University
  Nanjing, Jiangsu, China Recruiting
• Affiliated Hospital of Jiangnan University
  Wuxi, Jiangsu, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.