NCT07649122RecruitingPhase 3
This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer.
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET/CT imaging in patients with suspected recurrence of prostate cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 31 Aug 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Norroy Bioscience Co., LTD
- Diseases
- Prostate cancer
- NCT number
- NCT07649122
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 232
- From 31 Aug 2026 to the primary completion date, 30 Jun 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Drum Tower Hospital, Medical School of Nanjing University Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| Affiliated Hospital of Jiangnan University Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.