Double-blind Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Metastases in Men With Hormone-refractory Prostate Cancer
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Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Closed | 18 and over | Pharmaceutical / Industry | 20050103 NCT00321620 |
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 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
Trial Lead Organizations/Sponsors
Amgen, Incorporated
| MD |  | Study Director |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00321620
Information obtained from ClinicalTrials.gov on November 20, 2012
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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