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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorHoag Memorial Hospital Presbyterian

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Known allergy/hypersensitivity to PSMA-targeted imaging agents

Other active malignancy, other than the known prostate cancer

Trial design

Treatments tested in this trial

  • Copper 61-PSMA PET/CT

Treatment groups

8 Participants
are divided into 1 treatment group