drugset / Trial / NCT04614363

68 Ga-PSMA for High Risk Prostate Cancer

NCT04614363

Phase 1/2 Completed 80 enrolled The Methodist Hospital Research Institute
NaSingle-groupOpen-labelDiagnostic

Summary

This is a prospective, single-center, open-label pilot study of 68GA-PSMA-11 given at a single time prior to PET/CT imaging in men with localized high risk prostate cancer or biochemical recurrence. The imaging agent (68 Ga-PSMA 11 will be administered on an outpatient basis. It will be administered prior to the PET/CT imaging. The objective is to evaluate the distribution of 68GA-PSMA-11 in tissues and to determine if this alters the planned clinical management.

Timeline

Start
2020-10-13
Primary completion
2022-02-26
Completion
2023-04-25

Drugs

EvaluationDrugModalityDoseRoute
Subject 68Ga-PSMA-11 Diagnostic / imaging agent 111 mbq Intravenous
Subject 68Ga-PSMA-11 Diagnostic / imaging agent 259 mbq Intravenous

Indications