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.

May 22, 2026 updated by: Norroy Bioscience Co., LTD
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Prostate-specific membrane antigen (PSMA) is a transmembrane surface protein highly overexpressed in over 90% of prostate cancer lesions.⁶⁸Ga-NYM032 Injection, a PSMA-targeted radiotracer, is indicated for PET/CT imaging in patients with prostate cancer. Patients will receive 68Ga-NYM032 imaging to identify pelvic lymph node involvement.

Study Type

Interventional

Enrollment (Estimated)

365

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68-Ga-NYM032
Drug: 68-Ga-NYM032
IV injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity and specificity
Time Frame: up to 30 days
Assessing the sensitivity and specificity of 68Ga-NYM032 Injection positron emission tomography (PET) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norroy Bioscience Co., LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G03202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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