A 2 Part Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer (ARMOR2)

Inclusion Criteria:

1. Male age > 18 years
2. Histologically or cytologically confirmed adenocarcinoma of the prostate (excluding neuroendocrine differentiation or small cell histology)
3. Ongoing androgen blockade (therapy with gonadotropin-releasing hormone (GnRH) analogues, or orchiectomy) demonstrated by serum testosterone concentration of less than 50 ng/dL.
4. Demonstration of progression while on androgen blockade (based upon PCWG2 guidelines).
5. Eastern Cooperative Oncology Group (ECOG) Performance Status <2

Exclusion Criteria:

1. Prior treatment with androgen directed hormonal therapies (prior abiraterone treatment allowed for some study arms)
2. Prior chemotherapy (unless allowed for some study arms).
3. Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
4. Prior use of any chronic systemic glucocorticoids .
5. Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
6. Prior treatment with Alpharadin® (radium-223 chloride)
7. Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment
8. Treatment with Coumadin® (warfarin sodium) or other anti-coagulant therapy (except aspirin) < 4 weeks prior to enrollment
9. Severe systemic diseases or active uncontrolled illnesses.
10. Abnormal heart function
11. Liver metastases
12. Brain metastases (unless stable disease >3 mos. by scan without additional CNS-directed therapy)
13. The patient has known allergy to any of the treatment components
14. Any physical or mental condition or social situation that in the opinion of the Investigator may interfere with the patient's ability to comply with the trial procedures
15. History of excessive alcohol consumption
16. Use of any substance known to cause AME