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Study Complete
Sponsor ID
20050103

Study of denosumab vs. zoledronic acid to treat bone metastases in men with hormone-refractory prostate cancer

Sponsor ID
20050103
Clinicaltrials.gov ID
NCT00321620
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
1904
Additional Study Details

Protocol Summary

Primary Outcome Measures

Time to the First On-Study SRE (Non-inferiority)

Timeframe: Up to 40.5 months

Secondary Outcome Measures

Time to the First On-Study SRE (Superiority)

Timeframe: Up to 40.5 months

Time to the First-And-Subsequent On-Study SRE

Timeframe: Up to 40.5 months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Advanced/Metastatic Cancer
    • Sex
    Assigned Male at Birth
    Trial Dates
    Apr 2006 - Oct 2009
    Inclusion and Exclusion 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