RecruitingPhase 1NCT06736054

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

Sponsor

Hoag Memorial Hospital Presbyterian

Enrollment

8 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Adenocarcinoma

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase I study is testing a new PET scan imaging agent called 61Cu-NODAGA-PSMA for detecting prostate cancer. The scan targets PSMA, a protein that is overexpressed on prostate cancer cells. **You may be eligible if...** - You are 18 years of age or older - You have biopsy-proven prostate cancer - You have at least one PSMA-positive lesion on a recent PSMA PET/CT scan (within the last 30 days) - Your kidney function is acceptable (creatinine ≤1.4 or creatinine clearance ≥60 mL/min) - Your general health score (ECOG) is 0 or 1 **You may NOT be eligible if...** - You have a known allergy to PSMA-targeted imaging agents - You have another active cancer (other than prostate cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.