Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
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About
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.
Enrollment
Sex
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
18 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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