A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer

Exclusion Criteria

• •1. History of impaired pituitary or adrenal gland function
• •2. Prior therapy with abiraterone acetate, orteronel, ketoconazole or any other CYP17 inhibitor
• •3. Prior therapy with enzalutamide
• •4. Prior use of experimental androgen receptor antagonist
• •5. Previous exposure to Ra-223:Xofigo
• •6. Previous chemotherapy
• •7. Initiation of bisphosphonate or denosumab therapy within 30 days prior to the start of study medication. Patients who are on a stable dose of these medications for at least 30 days at the time of starting study drug are eligible.
• •8. Therapy with estrogen within 30 days prior to the start of study medication
• •9. Use of systemic glucocorticoids equivalent to \> 10 mg of prednisone daily; patients who have discontinued or have reduced dose to \< 10 mg prednisone within 14 days prior to the start of study medication will be eligible
• •10. Prior use of any herbal products that may decrease PSA levels (eg., saw palmetto) within 30 days of start of study medication
• •11. Known metastases to the brain or CNS involvement
• •12. History of other malignancy within the previous 2 years
• •13. Major surgery within 30 days prior to the start of study medication
• •14. Blood transfusion within 30 days of screening
• •15. Serious, persistent infection within 14 days of the start of study medication
• •16. Persistent pain that requires the use of a narcotic analgesic
• •17. Known gastrointestinal disease or condition that may impair absorption
• •18. Treatment with any investigational drug within 4 weeks prior to Day -1 of the study.
• •19. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus
• •20. Have poorly controlled diabetes.
• •21. Uncontrolled hypertension
• •22. History of New York Heart Association (NYHA) class III or IV heart failure
• •23. Serious concurrent illness, including psychiatric illness, that would interfere with study participation
• •24. Inability to swallow tablets whole
• •25. Known hypersensitivity to any excipients in study medications
• •26. Moderate to severe hepatic impairment (Child-Pugh Classes B and C)