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

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