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

Recruiting now · Phase 1

Conditions studied: Prostate Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT06736054

Run by

Hoag Memorial Hospital Presbyterian

People needed

8

Starts

2024-10-14

Expected to finish

2025-03-31

Last updated by the study team

2024-12-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known allergy/hypersensitivity to PSMA-targeted imaging agents
• Other active malignancy, other than the known prostate cancer

Where it is running

• Hoag Memorial Hospital Presbyterian — Irvine, California, United States (enrolling)

Full record on ClinicalTrials.gov

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