Sorafenib Tosylate and Gene Expression Analysis in Patients Undergoing Surgery For High-Risk Localized Prostate Cancer

Exclusion Criteria

• •Prior therapy for prostate cancer including conventional androgen deprivation therapy, radiotherapy (external beam or brachytherapy), cryotherapy, and/or cytotoxic chemotherapy
• •Any known metastasis; patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis
• •Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
• •Another malignancy, other than non-melanoma skin cancer, during the past 5 years
• •History of bleeding diathesis or unexpected surgical bleeding
• •Patients with active coagulopathy
• •Cardiac disease: Congestive heart failure \> class II NYHA; patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
• •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• •Uncontrolled hypertension, as defined by systolic blood pressure consistently in excess of 150 mmHg, or diastolic pressure consistently in excess of 90 mmHg
• •Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
• •Pulmonary hemorrhage/bleeding event \>= CTCAE Grade 2 within 4 weeks of first dose of study drug
• •Any other hemorrhage/bleeding event \>= CTCAE Grade 3 within 4 weeks of first dose of study drug
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
• •Patients may not be concurrently receiving any chemotherapy, immunotherapy, hormonal therapy, or molecular targeted agents to treat their prostate cancer
• •Patients may not be receiving any other investigational agents
• •Therapeutic anticoagulation with heparin, low-molecular weight heparin, or warfarin within the last 4 weeks
• •Patients may not be using rifampin, digoxin, quinidine, ketoconazole, itraconazole, cyclosporine, carbamazepine, phenytoin, phenobarbital, St. John's Wart, or products containing grapefruit juice
• •Patients may not be using bevacizumab or any other drugs that target VEGF or VEGF receptors
• •Active clinically significant infections (\>= grade 2 NCI-CTCAE version 3.0); patients may enroll after infection resolves
• •HIV-positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with Sorafenib
• •Any condition that impairs patient's ability to swallow whole pills
• •Any malabsorption problem