TheranosticTrials.org

Clinical Trial · NCT03001869

68Ga-PSMA PET/CT in Prostate Cancer

Overview

The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and as a diagnostic and decision making tool in the management prostate cancer patients.The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.

Sponsor

Unknown Organization

Phase

Phase 3

ClinicalTrials.gov

NCT03001869

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • ECOG performance status 0 - 3, inclusive
  • Previously diagnosed with prostate cancer, under referring physician's care
  • Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulationGlobal

Exclusion

  • Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
  • BCR: Biochemical recurrence as defined by serum PSA \> 0.1 ng/ml following either radical prostatectomy or curative-intent radiotherapy or other prostate-ablative definitive management
  • HRS: Staging of high risk patients as defined by any one of the following:
  • Equivocal conventional staging such as CT, MRI or bone scan
  • Serum PSA \> 10 ng/ml
  • T stage of T3 or greater on TNM staging
  • Gleason score \> 7