Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer

An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer

This is a multi-national, multi-center, open-label, single-arm extension study for the prolongation of bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer. Patients currently participating in the phase 3 study 20050147 (NCT00286091) will be offered this study if a positive benefit:risk compared with placebo is determined in the 20050147 study. The primary endpoint of the 20050147 study is bone metastases-free survival determined by the time to first occurrence of bone metastases (either symptomatic or asymptomatic) or death from any cause. Participants will receive open-label denosumab administered once every 4 weeks (Q4W) subcutaneously (SC) until they developed a bone metastasis or for up to 3 years, whichever comes first.

Inclusion Criteria:

• Subjects currently undergoing every 4 weeks scheduled assessments in the phase 3 study 20050147
• Subjects must sign the informed consent before any study specific procedures are performed

Exclusion Criteria:

• Developed sensitivity to mammalian cell derived drug products during the 20050147 study
• Currently receiving any unapproved investigational product other than denosumab
• Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures