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Advanced prostate cancer is a highly bone-tropic disease, as demonstrated by the fact that >90% of men who die of metastatic prostate cancer have evidence of bone metastases. Administration of zoledronic acid has been shown to reduce skeletal-related events (SREs) compared with placebo in men with metastatic castrate-resistant prostate cancer (mCRPC; J Natl Cancer Inst 2002; 94:1458 and J Natl Cancer Inst 2004; 96:879). However, despite this treatment, SREs continue to occur in mCRPC patients.
Now, an international group of investigators has conducted an industry-sponsored, randomized, double-blind, phase III trial to determine whether denosumab — a human monoclonal antibody that binds to the receptor activator of nuclear factor-κB ligand (R…