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

Phase 3

Completed

• Conditions: Bone Metastases
• Interventions: Drug: zoledronic acid; Biological: denosumab

• Registration Number: NCT00321620
• Lead Sponsor: Amgen

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-01
• Study First Submitted: 2006-05-02
• Study First Submitted QC: 2006-05-02
• Study First Posted: 2006-05-04
• Primary Completion: 2009-10-01
• Disposition First Submitted: 2010-06-29
• Disposition First Submitted QC: 2010-06-29
• Disposition First Posted: 2010-07-01
• Results First Submitted: 2010-12-10
• Study Completion: 2012-02-24
• Results First Submitted QC: 2014-02-04
• Results First Posted: 2014-03-21
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1904

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
zoledronic acid	zoledronic acid	-
denosumab	denosumab	-

Primary Outcome Measures

Name	Time	Method
Time to the First On-Study SRE (Non-inferiority)	Up to 40.5 months	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.

Secondary Outcome Measures

Name	Time	Method
Time to the First On-Study SRE (Superiority)	Up to 40.5 months	Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.
Time to the First-And-Subsequent On-Study SRE	Up to 40.5 months	Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.; This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.