Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate glad.
• Informed of, willing, and able to comply with, the requirements of the investigational study and have signed a written informed consent in accordance with institutional regulatory guidelines.
• Subjects defined as being at high risk for disease relapse based on the following criteria: PSA > 10 ng/ml, and any one of the following: Gleason > 7 or T stage > T2b.
• Patients must have elected to and are a candidate to undergo a radical prostatectomy.
• Males greater than 18 years of age and less than or equal to 75 years of age (physiologic) any racial/ethnic group.
• Free of significant abnormal findings as determined by screening history, physical exam, vital signs (blood pressure, heart rate, respiration rate, and temperature), and urinalysis.
• Performance status: ECOG < 2.
• Life expectancy of at least 5 years.
• Absolute granulocyte count > 1,500/mm3.
• Platelet count > 100,000.
• Hemoglobin > 9.0 g/dL.
• Serum calcium < 12.0 mg/dL Adequate hepatic function as evidenced by ALT and AST values within normal range. Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) < 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are due to underlying malignancy.
• Creatinine < 1.5 ULN.

Exclusion Criteria:

• Patients who have stage T2a or less prostate cancer, Gleason < 6, PSA <10-ng/mL.
• Prior hormonal, surgical, radiopharmaceutical or radiation therapy, cryotherapy, biological response modifiers, or systematic chemotherapy to treat prostatic carcinoma.
• Surgery within four weeks of study entry.
• Evidence of regional and/or distant metastases.
• Use of an investigational drug within 30 days prior to study entry.
• NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
• Any of the following thing the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
• Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2.
• Prolonged QTc interval on baseline EKG.
• Uncontrolled Hypertension (>150/100 mm Hg despite optimal medical therapy).
• Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit juice or St. John's Wort while on the study
• Known active infection.