A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients

INCLUSION CRITERIA: * Patient who had histologically confirmed adenocarcinoma of the prostate. * Patient must have radiologically documented metastatic disease. * Patients should have received at least 12 weeks of docetaxel chemotherapy or a cumulative docetaxel dose of 300 mg/m2 and have disease progression on docetaxel-based therapy. Patients must have progressed after prior hormonal therapy (e.g. medical or surgical castration) as defined by a castrate level of testosterone (less than 50 ng/mL). If patient underwent medical castration, it must be continued during the study. * Progressive disease may be documented by: * Non-measurable disease: * Serum PSA progression defined as a rise in at least 2 consecutive serum PSA values, each obtained at least 1 week apart and an absolute value greater than 2.0 ng/ml or, * Appearance of two or more new lesions on bone scan. * Patients with treated epidural lesions and no other epidural progression will be eligible. * Measurable disease * Documented progression of disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria demonstrating at least one visceral or soft tissue metastatic lesion (including new lesion). * Nodal or visceral progression will be sufficient for trial entry independent of PSA * Only lymph nodes ≥ 2 cm in diameter will be used to assess for a change in size. * Previously irradiated lesions, primary prostatic lesion, and bone lesions will be considered non-measurable disease. * Patient is 18 years or older. * Patient had a Karnofsky Performance Status (KPS) of at least 70% or Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2. * Life expectancy of \> 6 months. * Patient with adequate organ function as defined as * Absolute Neutrophils Count greater than 1500 cells/mm3 * Platelets greater than 100,000 cells/mm3 * Hemoglobin greater than 8 g/dL, * Adequate liver function as documented by: * Total Bilirubin \</= 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis. * AST and ALT \</= 2.5 ULN. (In determining eligibility the more abnormal of the two values (AST or ALT) should be used.) * Serum creatinine \</= 2.0 mg/dl or \</= 1.5 x institutional upper limit of normal. * Male patient must be willing to use an acceptable barrier method for contraception; and must agree not to father a child whilst receiving treatment with Azacitidine and up to six months after last dose. * Patients may have a history of prior malignancy (≥ 5 years prior) provided that the patient is currently disease free and off all therapy for that malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. * Patients must be informed of the investigational nature of the treatment and must give signed written and informed consent. EXCLUSION CRITERIA: * Patients who have received strontium 89 (metastron®), Samarium 153 (quadramet®) radiation therapy within 8 weeks of enrollment. * Evidence of significant active infection during screening for eligibility. * Patients who have had a psychiatric illness that could potentially interfere with completion of treatment according to protocol. * Patients who had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. There is no wash-out period for patients who received Zytiga. * Patient who had brain metastases. * Patient who had history of allergic reactions attributed to compound or similar chemical or biological composition to azacitidine (Vidaza®) or docetaxel or other drugs formulated with polysorbate 80 or mannitol. * Patient had major surgical procedure within 28 days before Day 1 of treatment. * Hepatic malignancy.