Abiraterone Acetate in Combination With Docetaxel After Disease Progression to Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer.

Inclusion criteria

• Willing and able to provide written informed consent
• Male aged 18 years and above
• Histologically or cytologically confirmed adenocarcinoma of the prostate.
• Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI.
• Prostate cancer progression to previous castration treatment documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria or bone scan progression
• Asymptomatic or mildly symptomatic from prostate cancer
• Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM).
• Previous anti-androgen therapy and progression after withdrawal.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Hemoglobin >= 10.0 g/dL independent of transfusion
• Platelet count >= 100,000/µL
• Serum albumin >= 3.5 g/dL
• Serum creatinine < 1.5 x ULN or a calculated creatinine clearance >= 60 mL/min
• Serum potassium >= 3.5 mmol/L
• Liver function: a. Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert's disease) b. AST or ALT < 2.5 x ULN
• Life expectancy of at least 6 months
• Patients who have partners of childbearing potential must be willing to use a method of birth control

Exclusion criteria

• Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
• Any chronic medical condition requiring a higher dose of corticosteroid than 10mg prednisone/prednisolone daily.
• Pathological finding consistent with small cell carcinoma of the prostate
• Liver or visceral organ metastasis
• Known brain metastasis
• Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
• Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
• Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day
• Radiation or radionuclide therapy for treatment of metastatic CRPC
• Previously treated with ketoconazole for prostate cancer for greater than 7 days
• Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
• Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1
• Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1 Day 1
• Uncontrolled hypertension (systolic BP >= 160 mmHg or diastolic BP >= 95 mmHg).
• Active or symptomatic viral hepatitis or chronic liver disease
• History of pituitary or adrenal dysfunction
• Clinically significant heart disease
• Atrial Fibrillation, or other cardiac arrhythmia requiring therapy
• Other malignancy, except non-melanoma skin cancer, with a >= 30% probability of recurrence within 24 months
• Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1
• Any condition which, in the opinion of the investigator, would preclude participation in this trial.