A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC)

Exclusion Criteria

• •History of visceral metastasis, or visceral metastases
• •Malignant lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
• •Medical condition that would make prednisone (corticosteroid) use contraindicated
• •Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone bid
• •Treatment with more than one chemotherapy agent for prostate cancer
• •Prior systemic radiotherapy and hemibody external radiotherapy
• •History of pituitary or adrenal dysfunction
• •Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget's disease of bone)
• •Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
• •History of seizures (taking/not taking anticonvulsants), arteriovenous malformation in the brain, head trauma with loss of consciousness
• •Central nervous system (CNS) metastases