Hormone Refractory Prostate Cancer Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
The purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.
Participants were randomized to receive denosumab 120 mg or placebo every 4 weeks (Q4W) until
approximately 660 participants developed bone metastasis or died and the primary efficacy and
safety analyses were completed.
All participants undergoing scheduled assessments were offered open-label denosumab 120 mg
subcutaneous (SC) until they either developed a bone metastasis, obtained access to
commercially available product in this setting, or for up to 3 years, whichever came first.
For participants who ended participation before the open-label extension (OLE) phase or
withdrew from investigational product during the OLE phase, their survival data was to be
collected every 6 months for up to 3 years after their last dose of investigational product.
Participants in the Czech Republic and United Kingdom were enrolled under a separate protocol
for the OLE phase per Health Authority request, and are reported separately (Study 20080585;
NCT01824342).
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|---|---|---|---|
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