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

  • Recruiting
  • Diagnostic
  • Interventional
  • Drug
  • PHASE1
  • Hoag Memorial Hospital Presbyterian
  • 18 Years -


Study Purpose

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.

Intervention

Drug : Copper 61-PSMA PET/CT


Eligibility Requirements

info icon Biopsy proven prostate adenocarcinoma

info icon Age ≥ 18 years

info icon ECOG 0 or 1

info icon At least one site of PSMA-positive disease on a PSMA-targeted PET/CT performed within 30 days of trial recruitment

info icon Creatinine of ≤1.4 or Creatinine Clearance or ≥ 60 mL/minute.

info icon Known allergy/hypersensitivity to PSMA-targeted imaging agents

info icon Other active malignancy, other than the known prostate cancer

Recruiting status

Recruiting

Estimated enrollment

8

 
Study start date

Oct 14, 2024

Study end date

Mar 31, 2025

Last updated

Mar 24, 2025

Primary purpose

Diagnostic

Design

Interventional

Intervention

Drug

Study phase

PHASE1

Allocation

Na

 

Sponsor:

Hoag Memorial Hospital Presbyterian

Collaborator:

N/A

Investigator:

N/A

NCT06736054

Clinic Location Investigator Distance RECRUITING STATUS Contact