CompletedPhase 3

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

1,904 participantsStarted 2006-04-01

Plain-language 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

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time to the First On-Study SRE (Non-inferiority)

Timeframe: Up to 40.5 months

Trial details

NCT IDNCT00321620

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-10-01

Results submitted2010-12-10

View on ClinicalTrials.gov More Bone Metastases trials