Phase 3 Completed N=1,901 Randomized Quadruple-blind Supportive Care

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

bone metastases

Source: ClinicalTrials.gov NCT00321620 ↗

Enrolled (actual)

1,901

Serious AEs

61.6%

Results posted

Mar 2014

Primary outcomePrimary: Time to the First On-Study SRE (Non-inferiority) — 521.0; 629.0 Days — p=0.0002

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

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.