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OBJECTIVE To evaluate the pharmacokinetics, tolerability and effect on endocrinology of bicalutamide given as once-daily monotherapy at doses of > 150 mg to patients with locally advanced (MO) or metastatic (M1) prostate cancer, with efficacy as a secondary endpoint. PATIENTS AND METHODS Patients were initially enrolled to receive bicalutamide 300 mg in a non-randomized phase, after which further
