A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer
Recruiting · NCT06736054 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoag Memorial Hospital Presbyterian
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Biopsy proven prostate adenocarcinoma
- Age ≥ 18 years
- ECOG 0 or 1
- At least one site of PSMA-positive disease on a PSMA-targeted PET/CT performed within 30 days of trial recruitment
- Creatinine of ≤1.4 or Creatinine Clearance or ≥ 60 mL/minute.
Exclusion criteria
- Known allergy/hypersensitivity to PSMA-targeted imaging agents
- Other active malignancy, other than the known prostate cancer
Where it is running
1 location listed across 1 US state.
- Hoag Memorial Hospital Presbyterian - Irvine, California, United States