Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

Exclusion Criteria

• •Active infection or other medical condition that would make dexamethasone use contraindicated
• •Any chronic medical condition requiring a higher systemic dose of corticosteroid
• •Pathological finding consistent with small cell carcinoma of the prostate
• •Has imminent or established spinal cord compression based on clinical findings and/or MRI.
• •Chronic liver disease with Child-Pugh class C cirrhosis (see calculator in protocol)
• •Bilirubin \>3x ULN or AST and ALT \>5x ULN
• •Congenital prolonged QTc syndrome or QTc \> 500 msec (non-paced rhythm)
• •History of pituitary or adrenal dysfunction
• •Uncontrolled diabetes (Hemoglobin A1c \> 10%) or increasing doses of insulin within the past 4 weeks due to poorly controlled glucoses.
• •Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 30 days of Cycle 1 Day 1 or currently enrolled in an investigational drug study
• •Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including, but not limited to:
• •* Any uncontrolled major infection.
• •* Crohn's disease or ulcerative colitis.
• •* Known or suspected toxic megacolon and/or known small bowel ileus.
• •* Known allergy to any of the compounds under investigation.
• •On antibacterial therapy within 30 days prior to administration of study treatment.
• •Any condition or situation which, in the opinion of the investigator, would put the subject at risk, or interfere with the subject's participation in this study.