Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis

Patients with biopsy-proven small cell or sarcomatoid histology

Patients with clinical or radiological evidence of bone (\>= 3 sites, or predominantly lytic if \< 3) or other extranodal metastasis

Patients who have had prior chemotherapy, experimental agents for prostate cancer, or patients receiving more than 8 weeks of prior hormone therapy will be excluded

Gastrointestinal abnormalities such as inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting absorption including total gastric resection; treatment for active peptic ulcer disease in the past 6 months; active gastrointestinal bleeding as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy; malabsorption syndromes

Anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (i.e., verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine); grapefruit juice is also a CYP3A4 inhibitor

Anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (i.e. carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort)

Patients with any infectious process that, in the opinion of the investigator, could worsen or its outcome be affected as a result of the investigational therapy

Patients with symptomatic congestive heart failure, unstable angina or myocardial infarction, coronary/peripheral artery bypass graft or repair, cerebrovascular accident or transient ischemic attack in the 12 months prior to randomization; or deep vein thrombosis or pulmonary embolism in the 6 months prior to randomization

Persistently uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease, or human immunodeficiency virus (HIV) infection

Inadequately controlled hypertension (defined as systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg) despite antihypertensive medication, or prior history of hypertensive crisis or hypertensive encephalopathy

Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)

Anticipation of need for major surgical procedure during the course of the study other than as outlined by the protocol

History of abdominal fistula or gastrointestinal perforation within 6 months prior to randomization

Serious, non-healing wound, active ulcer, or untreated bone fracture; any bone fractures must be healed

Known hypersensitivity to any component of axitinib or prior use of axitinib

Second malignancies (excluding non-melanoma skin cancer) unless treated with curative intent and disease-free for 3 years

Overt psychosis, mental disability, otherwise incompetent to give informed consent, or history of non-compliance

Planned participation in any other experimental drug study

What this study is about