Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer

Inclusion Criteria

• •Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small-cell histology.
• •Subject on continuous ADT with Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or bilateral orchiectomy.
• •Serum testosterone level below the target level at screening visit.
• •Subject with asymptomatic or mildly symptomatic prostate cancer.
• •Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• •Subject has progression of the disease as defined by rising PSA levels or progressive soft tissue or bony disease during CAB therapy in combination of bicalutamide and ADT.
• •A sexually active male subject and the subject's female partner who is of childbearing potential must use 2 acceptable birth control methods from screening to 3 months after the last dose of the study drug.
• •Subject must agree not to donate sperm from screening to 3 months after the last dose of the study drug.