Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- High-risk, locally advanced disease (T2b-T4 disease), meeting 1 of the following
criteria:

- Gleason score 8-10

- Prostate-specific antigen > 20 ng/dL AND Gleason score 7

- T2a disease allowed provided ≥ 5 biopsies contain Gleason score 4 +3
cancer (minimum of 10 biopsies total required)

- No evidence of metastatic disease within the past 60 days by physical examination,
chest x-ray, bone scan, and CT scan of abdomen and pelvis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Hemoglobin > 8 g/dL

- Absolute granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Creatinine ≤ 1.5 times ULN

- Blood pressure ≤ 150/100 mm Hg

- No cardiovascular disease, including any of the following:

- Unstable angina

- New York Heart Association class II-IV congestive heart failure

- History of myocardial infarction within the past 6 months

- History of stroke within the past 6 months

PRIOR CONCURRENT THERAPY:

- At least 4 weeks since prior major surgery

- No prior hormonal therapy (except finasteride for obstructive voiding symptoms) for
prostate cancer

- No prior or concurrent chemotherapy, biologic therapy, or radiotherapy for prostate
cancer