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NCT07615101RecruitingPhase 3

Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.

Open-label, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.

Source: ClinicalTrials.gov · Last updated 17 Aug 2026

Brief summary (registry, in English)

The investigators are imaging patients with newly diagnosed prostate cancer using a new Positron Emission Tomography (PET) imaging agent (68Ga-NYM032) in order to evaluate the safety and diagnostic performance.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
365 (estimated)
First submitted
22 May 2026
Start date
6 Aug 2026
Primary completion date
30 Jun 2027
Lead sponsor
Norroy Bioscience Co., LTD
NCT number
NCT07615101

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 365
  • From 6 Aug 2026 to the primary completion date, 30 Jun 2027
  • 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

  • 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.

Who the study is looking for

  • Patient is male and aged \>18 years old.
  • Biopsy proven prostate adenocarcinoma.
  • Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
  • ECOG performance status 0-2; expected survival ≥ 6 months.
    • 6\. 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

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Affiliated Hospital of Jiangnan University
Coordinator of this site? Confirm its status
WuxiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.