Trial Information

Summary: A study to treat men with Prostate Cancer with bone metastasis who are on androgen deprivation treatment.

Researchers have found that men undergoing hormone therapy to treat prostate cancer are as much as 40 percent more likely to develop a fracture than untreated patients. This is a two and half year study comparing denosumab with Zoledronic Acid (Zometa) to determine if denosumab is as helpful as zoledronic acid (Zometa) in slowing down bone loss and an occurrence of bone fracture.

Patient Eligibility Criteria:

• Male 18 years or older
• Histologically confirmed prostate cancer
• Documented failure of at least 1 hormonal therapy as shown by a rising PSA (ie, 3 consecutive rising PSAs taken at least 2 weeks apart from one another)
• Serum testosterone level of <50ng/dl due to either surgical or chemical castration
• No current or prior IV bisphosphonate for any reason
• No current or prior oral bisphosphonate for the treatment of bone metastases
• No planned radiation therapy or surgery to bone
• No prior administration of denosumab
• No known brain metastases
• No non-healed dental/oral surgery
• No prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
• No known history of second malignancy within the past 3 years, except for basal cell carcinoma

Qualified participants will receive:

• Study-related medication
• Study-related medical tests
• Study-related laboratory services

Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.

Study personnel will explain the trial in detail and answer any questions you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, study personnel will explain the reasons.

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