What this imaging test uses to find recurrent 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 phase 3 trial evaluates the diagnostic performance and safety of 68Ga-NYM032 PET/CT imaging in men with suspected recurrent prostate cancer after previous treatments. Patients will undergo PSMA-targeted imaging to help guide further treatment decisions. The study focuses on whether this radiotracer can improve detection of recurrent disease while monitoring for adverse effects. Eligibility requires histologically confirmed prostate adenocarcinoma, elevated PSA suggesting recurrence, and adequate performance status. The trial is sponsored by Norroy Bioscience Co., Ltd and involves two affiliated hospitals in Jiangsu, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Affiliated Hospital of Jiangnan University
  Wuxi, Jiangsu, China Recruiting
• Affiliated Drum Tower Hospital, Medical School of Nanjing University
  Nanjing, Jiangsu, China Not yet 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.