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
The aim of the study is to compare, in patients with symptomatic HRPC and skeletal
metastases, the efficacy of best standard of care plus Radium-223 dichloride versus best
standard of care plus placebo, with the primary efficacy endpoint being overall survival
Patients will be randomised in a 2:1 allocation ratio (Radium-223 dichloride:Placebo). The
study treatment consists of 6 intravenous administrations of Radium-223 dichloride or
placebo (saline) each separated by an interval of 4 weeks. The patient will be followed
until 3 years after first study drug administration.
Within the U.S., the trial is conducted under an IND sponsored by Bayer HealthCare
All patients received BSoC (Best Standard of Care).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Time from date of randomisation to the date of event
Christopher Parker, M.D.
The Royal Marsden Hospital, UK
Australia: Department of Health and Ageing Therapeutic Goods Administration
|Fountain Valley, California 92708|
|Miami, Florida 33176|
|Columbia, Missouri 65203|
|Philadelphia, Pennsylvania 19104|
|Metairie, Louisiana 70006|
|Las Vegas, Nevada 89109|