Clinical Trial Detail

This phase II trial studies how well giving abiraterone acetate works in treating patients with metastatic hormone-resistant prostate cancer. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Male

- Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study

- Written authorization for use and release of health and research study information has been obtained

- Be willing/able to adhere to the prohibitions and restrictions specified in this protocol

- Able to swallow the study drug whole as a tablet

- Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken

- Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate

- Histologically proven adenocarcinoma of the prostate

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Metastatic castration resistant prostate cancer as defined by serum testosterone < 50 ng/ml and one of the following:

-- i) Prostate specific antigen (PSA) level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart

-- ii) Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors)

-- iii) Progression of metastatic bone disease on bone scan with > 2 new lesions

- Maintenance of Lupron or antagonist unless previously treated with orchiectomy

- The presence of metastatic disease amenable to computed tomography (CT) or ultrasound guided biopsy; this may include thoracolumbar vertebral bodies, pelvis, femur or humerus, or soft tissue or nodal metastasis amenable to biopsy (excluding lung or pleural lesions)

- Patients may have received secondary hormonal manipulations (excluding prior Abiraterone acetate, MDV3100 or TAK700) or up to two cycles of chemotherapy; all prior therapy except Lupron must have been discontinued for more than 4 weeks before enrollment

- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN)

- Total bilirubin =< 1.5 x ULN

- Calculated creatinine clearance >= 60 mL/min

- Platelet count of >= 100,000/uL

- Absolute neutrophil count of > 1,500 cell/mm^3

- Hemoglobin >= 9.0 g/dL

Other eligibility criteria may apply.

- Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated

- Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible

- Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible

- Known brain metastasis

- Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment

- Active or symptomatic viral hepatitis or chronic liver disease

- History of pituitary or adrenal dysfunction

- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline

- Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy

- Administration of an investigational therapeutic within 30 days of screening

- Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligible

- Patients with any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements

- Patients unable to stop chronic anticoagulation for 3 days

- Patients with poorly controlled diabetes

- Patients with a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents

- Patients with a pre-existing condition that warrants long-term corticosteroid use in excess of study dose

- Patients with known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients

Other exclusion criteria may apply.