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

Amgen

Status and phase: Completed; Phase 3

Conditions: Bone Metastases

Treatments: Drug: zoledronic acid; Biological: denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00321620

20050103

Details and patient eligibility

About

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

Enrollment: 1,904 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,904 participants in 2 patient groups

zoledronic acid

Active Comparator group

Treatment:

Drug: zoledronic acid

denosumab

Experimental group

Treatment:

Biological: denosumab