Phase 3
N=1,432
Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
Hormone Refractory Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00286091 ↗Enrolled (actual)
1,432
Serious AEs
45.8%
Results posted
Apr 2015
Primary outcome: Primary: Bone Metastasis-free Survival — 768.0; 897.00 days — p=0.0284
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Denosumab (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Amgen
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Metastasis-free Survival |
768.0; 897.00 | 0.0284 sig |
| SECONDARY Time to First Bone Metastasis |
897.0; 1010.0 | 0.0317 sig |
| SECONDARY Overall Survival |
1365.0; 1335.0 | 0.9125 |
Summary
The purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.
Eligibility Criteria
Inclusion Criteria
- men with histologically confirmed prostate cancer
- bilateral orchiectomy at least 6 months before randomization or continuous androgen-deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) agonist or antagonist for at least 6 months before randomization
- total testosterone level less than 50 ng/dL,
- hormone refractory (androgen independent) prostate cancer demonstrated during continuous ADT/post-orchiectomy defined as: 3 consecutive prostate-specific antigen (PSA) values with PSA1 < PSA2 < PSA3, each PSA value must be separated by at least 2 weeks, PSA2 and PSA3 greater than or equal to 1.0 ng/mL,
- high risk for development of bone metastasis defined as PSA value greater than or equal to 8.0 ng/mL, obtained no more than 3 months before randomization OR PSA doubling time less than or equal to 10.0 months
Exclusion Criteria
- prior or current evidence of radiographically detectable bone metastasis
- known prior or current evidence of any metastatic involvement of distant organs (lymph node metastases in any region is acceptable)
- prior or current intravenous bisphosphonate administration
Data sourced from ClinicalTrials.gov (NCT00286091). 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.