A Phase II Trial of Avastin, Docetaxel and Androgen Deprivation Followed by Continued Avastin and Androgen Deprivation for Men With a Rising PSA After Local Therapy

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