Clinical Trial Details

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Study ID 7639
Investigator
Robert Montgomery,   Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Title Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Conditions Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Interventions Drug: abiraterone acetate
Drug: prednisone
Other: laboratory biomarker analysis
Other: pharmacological study
Phase Phase 2
Purpose 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.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
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 cycles 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)
  • 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
Study Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
Contact Robert B. Montgomery
206-598-0860
Information objtained from ClinicalTrials.gov, on 7/29/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503229


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