drugset / Trial / NCT02484339
Treatment of Advanced Castration Resistant Prostate Carcinoma With Limited Bone Metastases (α-RT)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Radium-223 dichloride | Other / unclassified | 0.055 mbq/kg | Intravenous |