NCT00286091

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,435 (actual)
• Sponsor: Amgen · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Hormone Refractory Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Denosumab	Administered by subcutaneous injection
BIOLOGICAL	Placebo	Same volume subcutaneous injection

Timeline

• Start date: 2006-01-24
• Primary completion: 2010-07-30
• Completion: 2014-04-09
• First posted: 2006-02-03
• Last updated: 2018-10-17
• Results posted: 2015-04-06