Trial Information

Summary: Have you been diagnosed with prostate cancer? Has the cancer spread to the bone? Is your PSA rising? If so you may qualify for a clinical research trial for the treatment of bone metastases in men with hormone-refractory prostate cancer.

This is an international, phase 3, randomized, double-blind, active-controlled study comparing denosumab with zoledronic acid in the treatment of bone metastases in men with hormone-refractory prostate cancer.

Each subject will receive either an SC injection of denosumab and an IV infusion of zoledronic acid placebo every 4 weeks or an SC injection of denosumab placebo and an IV infusion of zoledronic acid every 4 weeks.

Patient Inclusion Criteria:

• Men 18 years of age or older with histologially-confirmed prostate cancer.
• Evidence of at least 1 bone metastasis.
• Documented failure of at least one hormonal therapy as evidence by a rising PSA.

Patient Exclusion Criteria:

• Current or prior IV bisphosphonate administration for any reason.
• Current or prior oral bisphosphonate administration for the treatment of bone metastasis.
• Planned radiation therapy or surgery to bone.
• Prior administration of denosumab.
• Known brain metastases.
• Life expectancy less than 6 months.
• Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw.
• Active dental or jaw condition that requires oral surgery.
• Known history of second malignancy within the past 3 years, except for basal cell carcinoma.
• HIV and active infection with hepatitis B or hepatitis C.

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.