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

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.

Timeline

Start

2006-01-24

Primary completion

2010-07-30

Completion

2014-04-09

Outcome

Met primary endpoint

registry Placebo vs Denosumab; p = 0.0284; Hazard Ratio (HR) 0.85 (95% CI 0.73 to 0.98); Wald test NCT00286091 ↗

paper Denosumab significantly increased bone-metastasis-free survival by a median of 4·2 months compared with placebo PMID 22093187 ↗

Publications

• Smith MR, Saad F, Coleman R, Shore N, Fizazi K, Tombal B, Miller K, Sieber P, Karsh L, Damiao R, Tammela TL, Egerdie B, Van Poppel H, Chin J, Morote J, Gomez-Veiga F, Borkowski T, Ye Z, Kupic A, Dansey R, Goessl C. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet. 2012 Jan 7;379(9810):39-46. doi: 10.1016/S0140-6736(11)61226-9. Epub 2011 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Denosumab	Monoclonal antibody	120 mg	Subcutaneous

Indications