drugset / Trial / NCT02484339

Treatment of Advanced Castration Resistant Prostate Carcinoma With Limited Bone Metastases (α-RT)

NCT02484339

Phase 2 Unknown 274 enrolled University Hospital Freiburg
RandomizedParallel-groupOpen-labelTreatment

Summary

Phase II open-label study to evaluate the efficacy and safety of Radium-223 dichloride in combination with external beam radiotherapy (EBRT) vs. external beam radiotherapy alone in the treatment of advanced castration resistant prostate carcinoma with limited bone metastases. To evaluate if time to radiological progression according to the "Recommendations of the Prostate Cancer Clinical Trials Working Group" published by Scher et al. (JCO 2008) (based on new lesions in bone scan and CT /MRI or death) of Radium-223 dichloride combined with EBRT is superior compared to EBRT alone.

Timeline

Start
2014-12
Primary completion
2016-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Radium-223 dichloride Other / unclassified 0.055 mbq/kg Intravenous

Indications