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

Molecular Imaging (MI) uses tracers which emit radiation to provide clinically valuable imaging for patient with cancer. Most current MI agents utilize Fluorine 18 or Gallium 68 as the positron emitter for PET imaging. However, these isotopes have short half-lives which limit the geographic distribution range of tracers made with these isotopes. Copper 61 (61Cu) has a 3.3 hour half-life, which would allow for far greater distribution range following radiotracer production. This phase I trial will test the safety and effectiveness of a novel MI radiotracer that uses 61Cu as its positron emitting isotope and targets Prostate Specific Membrane Antigen (PSMA) for imaging prostate cancer. A successful trial will provide the ability to advance this novel 61Cu-NODAGA-PSMA radioisotope into phase II trials, as well as open a new paradigm into the production of MI radioisotopes with 61Cu.

NCT Number	NCT06736054
Lead Sponsor	Hoag Memorial Hospital Presbyterian
Conditions	Prostate Adenocarcinoma
Enrollment	8 participants
Start Date	2024-10-14
Primary Completion	2025-03-31 (estimated)
Study Completion	2025-03-31 (estimated)
Updated on ClinicalTrials.gov	2024-12-16