|Closed||Prostate Cancer||Phase II||
The purpose of this research study is to determine if the addition of dutasteride to a regimen with abiraterone acetate and prednisone will improve on therapy in patients with castrate-resistant prostate cancer and metastatic disease. This study will also help determine the side effects of the study treatment and how often they occur. Patients will receive abiraterone acetate and prednisone orally, once daily for 2 months (2 cycles) on an outpatient basis. At the start of cycle 3, dutasteride will be taken once daily. Patients will return to the clinic on Day 14 of the first 3 cycles for routine blood tests. Patients will come to the clinic every 12 weeks for a CT scan and/or x-ray of the chest, CT scan or MRI of the abdomen and pelvis, bone scan, and blood test for testosterone and other specialized blood test.
- Diagnosis of adenocarcinoma of the prostate
- Castrate resistant disease
- Metastatic disease
- Normal organ and marrow function
- Subjects with partners of childbearing potential must be willing to use adequate methods of birth control
- Uncontrolled intercurrent illness
- Uncontrolled hypertension
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease
- History of a different malignancy unless disease-free for at least 5 years
- Known brain metastasis
- History of gastrointestinal disorders
- Prior therapy with abiraterone acetate
- HIV-positive individuals on antiretroviral therapy
- Requirement for steroid use greater than the equivalent of 5 mg of prednisone daily
- Atrial fibrillation or other cardiac arrhythmia requiring therapy
- Thromboembolism in the last 6 months
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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- 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.