RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2024-10-14
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06736054

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Biopsy proven prostate adenocarcinoma
  2. 2. Age ≥ 18 years
  3. 3. ECOG 0 or 1
  4. 4. At least one site of PSMA-positive disease on a PSMA-targeted PET/CT performed within 30 days of trial recruitment
  5. 5. Creatinine of ≤1.4 or Creatinine Clearance or ≥ 60 mL/minute.
  1. 1. Known allergy/hypersensitivity to PSMA-targeted imaging agents
  2. 2. Other active malignancy, other than the known prostate cancer

Contacts and Locations

Study Locations (Sites)

Hoag Memorial Hospital Presbyterian
Irvine, California, 92616
United States

Collaborators and Investigators

Sponsor: Hoag Memorial Hospital Presbyterian

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-14
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2024-10-14
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • PSMA
  • PET/CT
  • Phase 1

Additional Relevant MeSH Terms

  • Prostate Adenocarcinoma