A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer
Hoag Memorial Hospital Presbyterian
Summary
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.
Description
This is a phase 1, non-randomized study. Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET/CT imaging 60 (+/- 10) minutes post radiotracer administration. This is a diagnostic imaging study. As the imaging agent will not have a treatment effect, efficacy evaluations that are standard in treatment protocols will not be performed. We expect to enroll 6-10 patients in the proposed study. The sample size is exploratory. For the primary objective of safety, side effects will be monitored the day of and the day following radiotracer…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Biopsy proven prostate adenocarcinoma 2. Age ≥ 18 years 3. ECOG 0 or 1 4. At least one site of PSMA-positive disease on a PSMA-targeted PET/CT performed within 30 days of trial recruitment 5. Creatinine of ≤1.4 or Creatinine Clearance or ≥ 60 mL/minute. Exclusion Criteria: 1. Known allergy/hypersensitivity to PSMA-targeted imaging agents 2. Other active malignancy, other than the known prostate cancer
Interventions
- DrugCopper 61-PSMA PET/CT
TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET/CT imaging 60 (+/- 10) minutes post radiotracer administration.
Location
- Hoag Memorial Hospital PresbyterianIrvine, California