drugset / Trial / NCT03001869

68Ga-PSMA PET/CT in Prostate Cancer

NCT03001869

Phase 3 Completed 540 enrolled Sir Mortimer B. Davis - Jewish General Hospital
NaSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
2017-07-01
Primary completion
2023-07-01
Completion
2023-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject 68Ga-PSMA-11 Diagnostic / imaging agent

Indications