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A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer

Primary To assess the relative efficacy of the combination of androgen suppression (AS) + radiotherapy (RT) followed by androgen suppression vs. AS + RT followed by docetaxel and prednisone chemotherapy + androgen suppression in a population of patients with clinically localized prostate cancer with unfavorable prognostic factors. The primary endpoint will be overall survival. Secondary 1. To assess the differences between the two treatment arms for: Biochemical control (freedom from PSA failure) Local control Freedom from distant metastases Disease-free survival Incidence of adverse events 2. In addition, the following will be assessed: Validity of PSA-defined endpoints as a surrogate for the primary objective The time interval between biochemical failure and distant metastases with respect to testosterone level 3. To collect paraffin-embedded tissue blocks, serum, plasma, and buffy coat cells for future translational research analyses.

Primary To assess the relative efficacy of the combination of androgen suppression (AS) + radiotherapy (RT) followed by androgen suppression vs. AS + RT followed by docetaxel and prednisone chemotherapy + androgen suppression in a population of patients with clinically localized prostate cancer with unfavorable prognostic factors. The primary endpoint will be overall survival. Secondary 1. To assess the differences between the two treatment arms for: Biochemical control (freedom from PSA failure) Local control Freedom from distant metastases Disease-free survival Incidence of adverse events 2. In addition, the following will be assessed: Validity of PSA-defined endpoints as a surrogate for the primary objective The time interval between biochemical failure and distant metastases with respect to testosterone level 3. To collect paraffin-embedded tissue blocks, serum, plasma, and buffy coat cells for future translational research analyses.