A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate
Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL
Demonstration of progression while on androgen blockade
Eastern Cooperative Oncology Group (ECOG) Performance Status <2

Exclusion Criteria:

Depending upon patient prior treatment the following apply:

Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone, TAK-700, ARN-509, ketoconazole*, enzalutamide, or galeterone) - Treatment naïve only
Prior treatment with CYP17 inhibitors (e.g. TAK-700, ketoconazole*) or AR antagonists (e.g. enzalutamide, ARN-509,) or galeterone - abiraterone refractory only
Prior treatment with CYP17 inhibitors (e.g. abiraterone, TAK-700, ketoconazole*) or AR antagonists (e.g. ARN -509) or galeterone - enzalutamide refractory only
Prior chemotherapy (unless allowed for some study arms)
Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
Prior use of any chronic systemic glucocorticoids .
Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
Prior treatment with Alpharadin® (Xofigo®)
Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment
Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) < 4 weeks prior to enrollment
Severe systemic diseases or active uncontrolled illnesses.
Abnormal heart function
Liver metastases
Brain metastases (unless stable disease >3 mos. by scan without additional CNS-directed therapy)
The patient has known allergy to any of the treatment components
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
History of excessive alcohol consumption
Use of any substance known to cause AME