PET Scan Tests a New Imaging Agent for Suspected Prostate Cancer Return
Tests a new imaging agent with PET scans in men suspected of prostate cancer recurrence.
Plain-language title generated from the registry record
Registry title: This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer.
Key facts
- Where
- Nanjing and Wuxi, ChinaSee the 2 sites
- Phase
- Phase 3
Where in China
- Affiliated Drum Tower Hospital, Medical School of Nanjing UniversityNanjing, ChinaNot yet recruiting
- Affiliated Hospital of Jiangnan UniversityWuxi, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Norroy Bioscience Co., LTD
- Trial code
- NCT07649122
- Record updated
- 15 September 2026
- Original description
This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET/CT imaging in patients with suspected recurrence of prostate cancer.Read full original descriptionShow less
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.
Inclusion: Patient is male and aged >18 years old; 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):; Post-radical prostatectomy (RP): PSA ≥0.2 ng/mL on two consecutive measurements obtained ≥6 weeks after surgery; Post-radiotherapy (as defined by the ASTRO-Phoenix consensus): PSA rise ≥2 ng/mL above the PSA nadir; Participants with recurrence after other treatments: PSA rise ≥2 ng/mL above the PSA nadir; ECOG performance status 0-2; expected survival ≥ 6 months; Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion: 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; 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; Known hypersensitivity to the active ingredient or excipients of the study drug; Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance; Participants not capable of getting PET study , or inability to lay still for the duration of the exam.