TheranosticTrials.org

Clinical Trial · NCT06235099

Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

Overview

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent prostate cancer after radical prostatectomy or radiation therapy.

Sponsor

Unknown Organization

Phase

Phase 3

ClinicalTrials.gov

NCT06235099

Drug / Compound

PSMA I&T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTAGA

Eligibility

Inclusion

  • Prior radiation therapy: 2 ng/mL rise in PSA over post-treatment nadir.
  • Patients with histologically proven prostate adenocarcinoma.
  • Prior radical prostatectomy (greater than 6 weeks prior to screening) or radiation therapy (greater than 1 year prior to screening) with curative intent.
  • Recurrence of disease defined as:
  • Prior radical prostatectomy: PSA greater than or equal to 0.2 ng/mL followed by subsequent confirmatory PSA value greater than or equal to 0.2 ng/mL or

Exclusion

  • Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.
  • Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway within the past 3 months. Patients with a rising PSA level while on ADT for greater than 6 months are eligible.
  • Patients with known hypersensitivity to the active substance or any of the excipients of the IP.
  • Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET scan) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.
  • Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan.
  • Patients who are administered any high-energy (greater than 300 keV) gamma-emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\&T administration.
  • Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.