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A randomized phase III study of neoadjuvant hormonal therapy in patients with localized prostate cancer.

The primary objective of this randomized trial is to evaluate the benefit of the addition of neoadjuvant hormonal therapy to escalated-dose external-beam radiation therapy in the treatment of patients with intermediate-risk carcinoma of the prostate. A secondary objective of this study is to determine prognostic factors for radiation response. All patients will have tissue oxygenation measured and biopsies taken before treatment at the time of fiducial marker insertion for radiation treatment planning and daily monitoring. In addition, patients randomized to the neoadjuvant bicalutamide arm will be asked to consider having these studies repeated before initiation of radiation therapy (after 3 months of hormonal therapy).