A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal-related Events in Men With Prostate Cancer to Bone
The purpose of the study is to determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal-related event.
201604031809
680
Adult males = 18 years of age must have:
• Histologic documentation of prostate adenocarcinoma
• At least one bone metastatsis by radiographic imaging
• Receive androgen deprivation therapy for treatment of prostate cancer
• Hormone therapy at any point prior to 6 months
• No prior treatment with a bisphosphonate
• No prior treatment with radiopharmaceuticals
Participants will be randomly assigned to one of two groups: placebo (salt and water) or zoledronic acid every four weeks.
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