Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer

Inclusion Criteria

• 18 years of age or older
• History of biopsy documented prostate cancer (any Gleason score)
• Past treatment with prostatectomy with our without salvage prostate/pelvic radiation or primary radiation
• If past prostatectomy, pathologic stage no greater than T1-3, N1, M0
• PSA recurrence with PSAdt 8 months or less. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be 2.0ng/ml or greater
• No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis on CXR
• Prior ADT allowed if less than 6 months and testosterone recovered to within 50 units of normal range
• ECOG Performance status of 0-1
• Absolute neutrophil count of 1, 500 mm3 or greater
• Platelet Count 100,000 mm3 or greater
• Total bilirubin within normal limits
• HG 8gm/dl or greater
• Testosterone within 50 units of normal range
• No history of bleeding or thromboses within the last 12 months that required medical intervention

Exclusion Criteria

• History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
• Medical condition requiring concomitant corticosteroids
• Active infection
• Prior chemotherapy
• Neuropathy requiring medical therapy
• Documented local recurrence or metastatic prostate cancer
• Inability to comply with study and/or follow-up procedures
• Life expectancy of less than 2 years
• Current, recent (within 4 weeks of first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
• Inadequately controlled hypertension
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• NYHA Grade II or greater congestive heart failure
• History of myocardial infarction or unstable angina within 12 months prior to study enrollment
• History of stroke or transient ischemic attack at any time
• Known CNS disease
• Significant vascular disease
• Symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrollment
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
• Serious, non-healing wound, ulcer, or bone fracture
• Proteinuria at screening
• Known hypersensitivity to any component of Avastin