Bevacizumab, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin and bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Bevacizumab may also make tumor cells more sensitive to radiation therapy. Giving bevacizumab together with hormone therapy and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with hormone therapy and radiation therapy works in treating patients with high-risk locally advanced prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Mason Hospital/Medical Center
• Treatments: Bevacizumab; Bicalutamide; Goserelin

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