Study of Everolimus Added to Combined Hormonal and Radiation Therapy for High Risk Prostate Cancer

Prostate cancer is very prevalent with an estimated \> 200,000 new cases and \> 25,000 deaths attributable to prostate cancer in the United States in 2010. Radiation treatment represents a commonly utilized method to treat prostate cancer with an excellent chance of controlling disease with biochemical control at 5-years in excess of 75% in men with locally confined but intermediate to high-risk disease. However, despite impressive biochemical control, local control remains a problem. Everolimus is being investigated as an anticancer agent based on its potential to act: * Directly on the tumor cells by inhibiting tumor cell growth and proliferation * Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity. Given the prevalence of PTEN deletion in high-risk prostate cancers as well as the evidence that tumor hypoxia leads to increased risks of failure after treatment with hormonal therapy and radiation, we hypothesis that inhibition of mTOR signaling in both tumor and vascular cells using everolimus concurrent with hormonal and radiation therapy will enhance the efficacy of radiation therapy without an unacceptable risk of toxicity in men with high-risk prostate cancer. Everolimus has not been approved by the FDA for the treatment of prostate cancer by itself or in combination with radiation and hormonal therapy. It is not known if this combination is safe and effective in prostate cancer. The FDA has allowed their combined use in this clinical trial.