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

Description

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.

Conditions

Prostate Adenocarcinoma

Study Overview

Study Details

Study overview

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.

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

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

Condition
Prostate Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Irvine

Hoag Memorial Hospital Presbyterian, Irvine, California, United States, 92616

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoag Memorial Hospital Presbyterian,

Study Record Dates

2025-03-31