Status:
COMPLETED
Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hormone-Resistant Prostate Cancer
Metastatic Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 place...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the magnitude of tissue testosterone suppression by abiraterone acetate in metastatic castrate-resistant prostate cancer (CRPC) (resistant to luteinizing hormone-r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01503229
Start Date
December 1 2012
End Date
March 12 2020
Last Update
May 14 2021
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109