A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer

• Clinical diagnosis of metastatic prostate cancer.

• Serum testosterone within institutional limits of normal.

• PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).

• DEXA scan within 2 years prior to registration.

• ECG within 42 days prior to registration and QTc interval ≤ 460 msec.

• LVEF within 42 days prior to registration and within institutional limits of normal.

• Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.

• Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.

• Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.

• Zubrod performance status of 0 - 2. Zubrod performance status 3 will be allowed if from bone pain only.

• ≥ 18 years of age.

• Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.