Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer

Bone metastases, Hormone-refractory prostate cancer, Skeletal, Fractures, Compressions, Bisphosphonates

Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.

Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.

Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.

Inclusion Criteria: Men >/= 18 years of age with histologically confirmed prostate cancer Radiographic evidence of at least one bone metastasis Failure of at least one hormonal therapy as evidenced by a rising PSA Serum testosterone level of <50 ng/dL ECOG PS 0, 1, or 2 Adequate organ function Exclusion Criteria: Current or prior IV bisphosphonate administration Current or prior oral bisphosphonates for bone mets Life expectancy of less than 6 months

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