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A double-blind, randomized, multiple dose, Phase III, multicenter study of Radium-223 in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastasesUnique Dataset IDProstat_BayerHe_2008_229
Clinical Trial Title
A double-blind, randomized, multiple dose, Phase III, multicenter study of Radium-223 in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases
Trial Summary and Conditions
Subjects were randomized 2:1 to receive either radium-223 dichloride or placebo study treatment using 3 binary variables for stratification: total ALP < 220 U/L versus total ALP ? 220 U/L; current use of bisphosphonates: yes versus no; and any prior use of docetaxel: yes versus no. Subjects received either radium-223 dichloride 50 kBq/kg b.w. or placebo (normal saline), plus BSoC. Subjects received 6 administrations of either radium-223 dichloride or placebo every 4 weeks. Subjects participated in 2 study periods: Treatment period: The treatment period was defined as the time from first injection of study drug, to 4 weeks after last injection of study drug, normally 24 weeks. Follow-up period: The follow-up period was defined as the time from 4 weeks after last administration of study drug until 3 years from first administration.
SAS data sets representing control arm patients including raw data on safety, efficacy, demographics, in SDTM format. Some data sets have been modified/eliminated in accordance with Bayer Anonymization procedures prior to release to Project Data Sphere.
To compare, in subjects with symptomatic hormone refractory prostate cancer (HRPC) and skeletal metastases, the efficacy of best standard of care (BSoC) plus radium-223 dichloride versus BSoC plus placebo, with the primary efficacy endpoint being overall survival. Secondary Objectives: To compare, in subjects with symptomatic HRPC and skeletal metastases receiving either BSoC plus radium-223 dichloride versus BSoC plus placebo: -Time to occurrence of specified disease events; -Changes and time to progression in serum prostate specific antigen (PSA) and total alkaline phosphatase (ALP) concentrations; -The acute and long-term safety profile; -Quality of life (QoL); -Health economics.
At the interim analysis, which involved 809 patients, radium-223, as compared with placebo, significantly improved overall survival (median, 14.0 months vs. 11.2 months; hazard ratio, 0.70; 95% confidence interval [CI], 0.55 to 0.88; two-sided P = 0.002). The updated analysis involving 921 patients confirmed the radium-223 survival benefit (median, 14.9 months vs. 11.3 months; hazard ratio, 0.70; 95% CI, 0.58 to 0.83; P<0.001). Assessments of all main secondary efficacy end points also showed a benefit of radium-233 as compared with placebo. Radium-223 was associated with low myelosuppression rates and fewer adverse events.
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PROTOCOL: ALSYMPCA study protocol June 24 2011.pdf
DATA DICTIONARY: pds_sdtm_specifications_final.xls
DATA (COMPARATOR ARM): data.zip