Ireland
--:--IST
Recruiting Phase 3

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

NCT07649122 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-08-31
Last updated
2026-09-15

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

68-Ga-NYM032

68-Ga-NYM032: IV injection

Study summary

This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET/CT imaging in patients with suspected recurrence of prostate cancer.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • PPV — up to12 months
    Positive predictive value (PPV)were calculated on a per-patient basis on 68Ga-NYM032 PET/CT for detection of tumor location confirmed by the composite truth standard.

Trial sites (2)

FacilityCityRegionStatus
Affiliated Drum Tower Hospital, Medical School of Nanjing University Nanjing Jiangsu Not Yet Recruiting
Affiliated Hospital of Jiangnan University Wuxi Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07649122 on ClinicalTrials.gov ↗ ← All trials in China