Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases

OUTLINE: This is a multi-center, randomized trial. STRATIFICATION FACTORS: Subjects will be stratified based on serum total alkaline phosphatase at baseline and extent of disease (described below). Randomization will occur within stratification group. * Extent of Disease: \<6 skeletal metastases with no visceral metastases versus ≥6 skeletal metastases or visceral metastases. * Serum total alkaline phosphatase at baseline: normal vs abnormal. Abnormal alkaline phosphatase is defined as \> 130 IU/L. Early Induction or Late Induction status will not be a stratification criterion. TREATMENT SCHEDULE: CONTROL ARM A All subjects will receive androgen deprivation therapy with a LHRH agonist (any LHRH agonist such as leuprolide acetate or goserelin acetate is acceptable) or a LHRH antagonist (degarelix) or bilateral orchiectomy, with dosage determined by the treating physician. Route of administration and cycle days will be administered as per package insert. Androgen deprivation therapy with LHRH agonist or LHRH antagonist will be given continuously. All subjects will receive bicalutamide, 50 mg Oral (PO) Daily TREATMENT SCHEDULE: EXPERIMENTAL ARM B All subjects will receive androgen deprivation therapy with a LHRH agonist (any LHRH agonist such as leuprolide acetate or goserelin acetate is acceptable) or a LHRH antagonist (degarelix) or bilateral orchiectomy, with dosage determined by the treating physician. Route of administration and cycle days will be administered as per package insert. Androgen deprivation therapy with LHRH agonist or LHRH antagonist will be given continuously. All subjects will receive bicalutamide, 50 mg oral (PO) daily All subjects will receive Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight, intravenous (IV bolus) every 28 days for 6 injections The following laboratory values must be obtained within 28 days prior to registration for protocol therapy: Hematopoietic: * Hemoglobin (Hgb) ≥ 8.0 g/dL (80 g/L) without packed RBC transfusion * Platelets ≥ 100 K/mm3 * Absolute neutrophil count (ANC) ≥ 1.5 K/mm3 Hepatic: * Total Bilirubin ≤ 2 x institutional upper limit of normal (ULN) except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL * Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x institutional ULN (≤ 5 x institutional ULN in the presence of liver metastases). * Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x institutional ULN (≤ 5 × institutional ULN in the presence of liver metastases). Renal: * Estimated Creatinine Clearance by Cockcroft-Gault formula ≥ 30 mL/min