At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)
In Brief
A Phase 3 clinical trial evaluating Radium-223 dichloride (Xofigo, BAY88-8223), Matching placebo (normal saline), and 2 other interventions for Prostatic Neoplasms. Completed, enrolled 806 participants across 163 sites in 19 countries.
Detailed Summary
To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.
Study Details
Timeline
Interventions
50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of NIST update) body weight, intravenous injection (IV-slow bolus), every 4 weeks for 6 cycles
Intravenous injection ( IV-slow bolus), every 4 weeks for 6 cycles
1000 mg once daily, oral, with best supportive care
5 mg twice daily, oral, with best supportive care