Bone Metastases Clinical Trial
Official title:
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
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.
The aim of the study was to compare, in patients with symptomatic hormone refractory
prostate cancer (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 (OS).
Patients were randomised in a 2:1 allocation ratio (Radium-223 dichloride:Placebo). The
study treatment consisted of 6 intravenous administrations of Radium-223 dichloride or
placebo (saline) each separated by an interval of 4 weeks. The patient were followed until 3
years after first study drug administration.
Within the U.S., the trial was conducted under an IND sponsored by Bayer HealthCare
Pharmaceuticals.
All patients received BSoC (Best Standard of Care).
This study has the original PCD as 14 October 2010, when a total of 316 deaths had been
observed; this resulted in the Independent Data Monitoring Committee's (IDMC's)
recommendation to stop the study as the primary efficacy analysis of overall survival had
crossed the pre-specified boundary for efficacy. Later an updated analysis of primary
endpoint in the first addendum was done with cut-off of 15 July 2011.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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