TheranosticTrials.org

Clinical Trial · NCT03396874

Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

Overview

This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body. To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.

Sponsor

University of Michigan Rogel Cancer Center

Phase

Phase 2

Contacts

Morand R Piert, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03396874

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

  • Karnofsky performance status of ≥ 50.
  • Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
  • Histopathological proven prostate adenocarcinoma.
  • Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.
  • Post radical prostatectomy (RP) - according to American Urological Association (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.

Exclusion

  • Current investigational therapy for prostate cancer.