Clinical Trial · NCT07649122

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

Overview

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

Sponsor

Norroy Bioscience Co., LTD

Phase

Phase 3

ClinicalTrials.gov

Drug / Compound

Isotope(s):

Target(s):

Ligand Class: Small Molecules

Eligibility

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):
1. Patient is male and aged \>18 years old.
Post-radical prostatectomy (RP): PSA ≥0.2 ng/mL on two consecutive measurements obtained ≥6 weeks after surgery;
Participants with recurrence after other treatments: PSA rise ≥2 ng/mL above the PSA nadir.
Post-radiotherapy (as defined by the ASTRO-Phoenix consensus): PSA rise ≥2 ng/mL above the PSA nadir;

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.
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.
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.
Known hypersensitivity to the active ingredient or excipients of the study drug.