Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00321620 | Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer | PHASE3 | COMPLETED | 1,904 | — | — | Apr 1, 2006 | Feb 24, 2012 | Aug 29, 2018 | - | — |
Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.
| Arm | Type | Description |
|---|---|---|
| zoledronic acid | ACTIVE_COMPARATOR | - |
| denosumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| zoledronic acid | DRUG | Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC |
| denosumab | BIOLOGICAL | Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes |
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...