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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorNorroy Bioscience Co., LTD

About this trial

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

Eligibility criteria

Qualifiers

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;

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 68-Ga-NYM032

Treatment groups

232 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators