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

• Status: Completed
• Trial end date: 2012-02-24
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab; Diphosphonates; Hormones; Zoledronic Acid

Criteria

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