drugset / Trial / NCT03490032

68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)

NCT03490032 ↗

Phase 1/2 Completed 30 enrolled Advanced Accelerator Applications
Non-randomizedSequentialOpen-labelDiagnostic

Summary

This was an open-label, multicenter, single dose, Phase I/II study to evaluate the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68\^Ga-PSMA-R2 in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).

Timeline

Start
2018-05-23
Primary completion
2019-08-20
Completion
2019-09-13

Drugs

EvaluationDrugModalityDoseRoute
Subject 68Ga-PSMA-R2 Diagnostic / imaging agent 3 mbq/kg Intravenous