At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomised, Multiple Dose, Phase III, Multicentre Study of Alpharadin in the Treatment of Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
In Brief
A Phase 3 clinical trial evaluating Radium-223 dichloride (Xofigo, BAY88-8223), Placebo, and 1 other intervention for Hormone Refractory Prostate Cancer and Bone Metastases. Completed, enrolled 921 participants across 134 sites in 19 countries.
Detailed Summary
ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.
Study Details
Timeline
Interventions
Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.
Isotonic saline 6 IV administrations separated by 4 weeks intervals.
Best standard of care is regarded as the routine standard of care at each center, for example local EBRT (External Beam Radiation Therapy), corticosteroids, antiandrogens, estrogens (e.g., stilboestrol), estramustine or ketoconazole.