Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer

• Bone Metastasis-free Survival [ Time Frame: From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months. ] [ Designated as safety issue: No ]
  The time to the first occurrence of bone metastasis (either symptomatic or asymptomatic) or death from any cause. Participants who did not experience bone metastasis or on-study death were censored at the last on-study contact date or the primary analysis data cutoff date, whichever came first. Median bone metastasis-free survival time was estimated using the Kaplan-Meier method.
  
  

• Time to First Bone Metastasis [ Time Frame: From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months. ] [ Designated as safety issue: No ]
  Time from randomization to the date of first occurrence of bone metastasis (either symptomatic or asymptomatic), excluding death. Participants who did not develop bone metastasis were censored at their last on-study bone assessment date or the primary analysis data cut-off date, whichever was first. Median time to first bone metastasis was estimated using the Kaplan-Meier method.
  
  
• Overall Survival [ Time Frame: From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months. ] [ Designated as safety issue: No ]
  Time from randomization to the date of death. Participants who were still alive or lost to follow-up by the primary analysis data cut-off date were censored at their last contact date (on-study or during survival follow-up) or the primary analysis data cut-off date, whichever was first.
  
  

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).