Name of the Trial
Phase III Randomized Study of Docetaxel and Prednisone with Versus without Bevacizumab in Patients with Hormone-Refractory Metastatic Adenocarcinoma of the Prostate (CALGB-90401). See the protocol summary at http://cancer.gov/clinicaltrials/CALGB-90401.

Principal Investigator
Dr. W. K. Kelly, Cancer and Leukemia Group B

Why This Trial Is Important
At initial diagnosis, most cases of prostate cancer are "hormone dependent," meaning they require androgens (male sex hormones) to grow. Hormone-dependent prostate cancer is often treated with therapies aimed at depriving the cancer of the needed hormones. Although initially effective, these hormonal therapies eventually fail because prostate cancers ultimately develop the ability to grow in the absence of androgens. Such cancers are called androgen-independent or hormone-refractory prostate cancers.

In this trial, men with hormone-refractory prostate cancer that has spread (metastasized) will receive standard chemotherapy with the drugs docetaxel and prednisone. Half of the participants will be randomly assigned to additionally receive treatment with a monoclonal antibody called bevacizumab.

Bevacizumab blocks the activity of a protein called vascular endothelial growth factor (VEGF). Many cancers use VEGF to help form the new blood vessels they need for continued growth. Furthermore, high levels of VEGF in the blood and urine of patients with hormone-refractory prostate cancer have been found to indicate a reduced likelihood of survival.

"A previous phase II clinical trial that combined docetaxel and bevacizumab resulted in improved outcomes over historical controls," said Dr. Kelly. "This phase III trial will answer the question of whether adding bevacizumab to docetaxel and prednisone actually does improve survival over the current standard of care."

Who Can Join This Trial
Researchers will enroll 1,020 men with metastatic prostate cancer that is progressing despite previous hormone therapy. See the list of eligibility criteria at http://www.cancer.gov/clinicaltrials/CALGB-90401.

Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study contacts at http://www.cancer.gov/clinicaltrials/CALGB-90401 or call NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.

An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.