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

NCT07649122 | Not Yet Recruiting Phase 3

• 1 other identifier: G03203
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PPV

  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.

  up to12 months

Study Arms (1)

68-Ga-NYM032

EXPERIMENTAL

Diagnostic Test: 68-Ga-NYM032

Interventions

68-Ga-NYM032 DIAGNOSTIC_TEST

IV injection

68-Ga-NYM032

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
• Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.

Sponsors & Collaborators

• Norroy Bioscience Co., LTD: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06