Status:
COMPLETED
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer
Lead Sponsor:
Amgen
Conditions:
Bone Metastases
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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
Eligibility Criteria
Inclusion
- 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
- Current or prior IV bisphosphonate administration
- Current or prior oral bisphosphonates for bone mets
- Life expectancy of less than 6 months
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2012
Estimated Enrollment :
1904 Patients enrolled
Trial Details
Trial ID
NCT00321620
Start Date
April 1 2006
End Date
February 24 2012
Last Update
August 29 2018
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