Phase 1 Study of 61Cu-NODAGA-PSMA PETCT Imaging for Men with Prostate Cancer

What this Trial Is About

Researchers are evaluating a new imaging agent, 61Cu-NODAGA-PSMA, in patients with prostate adenocarcinoma. This phase I trial aims to assess the safety and effectiveness of this novel radiotracer, which uses Copper 61 as a positron emitter. The study explores whether this agent can improve imaging of prostate cancer by targeting Prostate Specific Membrane Antigen PSMA with a longer half-life isotope, potentially allowing for wider distribution compared to current tracers. Participants will receive an intravenous injection of 100-300 MBq of 61Cu-NODAGA-PSMA. About 60 minutes after administration, they will undergo PETCT imaging to detect PSMA-positive malignant lesions. The trial is non-randomized and includes 6 to 10 patients. The study focuses on safety monitoring on the day of and day after the radiotracer administration, along with dosimetry calculations from imaging and blood samples. During the study, participants will be closely observed for any side effects within 24 hours after receiving the imaging agent. The number of suspected PSMA-positive lesions will be compared between this experimental tracer and the standard 18F-Piflufolastat PETCT. Safety and tolerability are primary outcomes, while dosimetry and lesion detection effectiveness are secondary outcomes. The total duration of participant involvement is short, focusing on imaging and follow-up within a day after the tracer administration.

A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer