|Recruiting||Prostate Cancer||Phase II||NCT01508234|
The purpose of this study is to evaluate the molecular effects of Abiraterone acetate and prednisone on prostate cancer. Participants will take Abiraterone acetate plus prednisone. While taking these drugs, patients will undergo sampling of cancer: one before treatment and one during treatment. To measure the body's overall response to Abiraterone acetate, the study follows patients for Prostate Specific Antigen (PSA) levels, cancer symptoms, and any side effects.
- Willing and able to provide written informed consent
- Written Authorization for Use and Release of Health and Research Study Information has been obtained
- Male aged 18 years and above
- Histologically proven adenocarcinoma of the prostate.
- ECOG performance status <2 (Karnofsky >60%; see Appendix B).
Castration resistant prostate cancer as defined by serum testosterone < 50 ng/ml and one of the following:
- 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 LHRH agonist or antagonist unless previously treated with orchiectomy.
- The presence of metastatic disease amenable to 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 or up to two cycles of chemotherapy.
- Laboratory values within protocol parameters
- Able to swallow the study drug whole as a tablet
- 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 13 weeks after last study drug administration.
- 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 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 < 45 % at baseline
- Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
- Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1
- 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 medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible.
- Any condition which, in the opinion of the investigator, would preclude participation in this trial.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.