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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Castrate-resistant Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Denosumab

Participants received denosumab 120 mg subcutaneously every 4 weeks for up to 3 years in this open-label extension study.

Group Type EXPERIMENTAL

Denosumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Interventions

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Denosumab

Administered by subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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XGEVA®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No