Phase 3
N=1,901
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer
Bone Metastases
Bottom Line
View on ClinicalTrials.gov: NCT00321620 ↗Enrolled (actual)
1,901
Serious AEs
61.6%
Results posted
Mar 2014
Primary outcome: Primary: Time to the First On-Study SRE (Non-inferiority) — 521.0; 629.0 Days — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- zoledronic acid (Drug); denosumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Amgen
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to the First On-Study SRE (Non-inferiority) |
521.0; 629.0 | 0.0002 sig |
| SECONDARY Time to the First On-Study SRE (Superiority) |
521.0; 629.0 | 0.0085 sig |
| SECONDARY Time to the First-And-Subsequent On-Study SRE |
584; 494 | 0.0085 sig |
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
Data sourced from ClinicalTrials.gov (NCT00321620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.