Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Condition: Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Adenocarcinoma
MeSH terms: Carcinoma; Prostatic Neoplasms
Intervention: Abiraterone Acetate; Laboratory Biomarker Analysis; Pharmacological Study; Prednisone
Intervention description: Given by mouth; Correlative studies; Correlative studies; Given PO
Intervention MeSH terms: Prednisone; Cortisone; Abiraterone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well abiraterone acetate works in treating patients with
      hormone-resistant prostate cancer that has spread from the primary site (place where it
      started) to other places in the body (metastatic). Abiraterone acetate may stop the growth of
      tumor cells by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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:

               -  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

               -  Evaluable disease progression by modified RECIST (Response Evaluation Criteria in
                  Solid Tumors)

               -  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 lines of chemotherapy; all prior
             therapy except Lupron must have been discontinued for more than 4 weeks before
             enrollment

          -  Serum potassium of >= 3.5 mEq/L

          -  Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 1.5 x upper limit
             of normal (ULN)

          -  Bilirubin levels < 1.5 x ULN

          -  Serum albumin of >= 3.0 g/dL

          -  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

        Exclusion Criteria:

          -  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 requiring therapeutic anticoagulation (e.g., warfarin, dabigatran, heparin,
             or low molecular weight heparins [Lovenox, dalteparin])

          -  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

          -  Child-Pugh class B or C hepatic impairment