Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Prostate Cancer Home Page 2 NCI's gateway for information about prostate cancer.

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 ³.

Principal Investigator

Dr. William K. Kelly, Cancer and Leukemia Group B.

Dr. William K. Kelly Principal Investigator

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."

Contact Information

This clinical trial is no longer accepting new patients. To find other clinical trials for prostate cancer, search the NCI database of clinical trials ¹ or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.

Glossary Terms

A drug used to treat several types of cancer, including certain types of colorectal, lung, breast, and kidney cancers and glioblastoma. It is also being studied in the treatment of other types of cancer. Bevacizumab binds to vascular endothelial growth factor (VEGF) and may prevent the growth of new blood vessels that tumors need to grow. It is a type of antiangiogenesis agent and a type of monoclonal antibody. Also called Avastin.

A type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. There are many kinds of monoclonal antibodies. Each monoclonal antibody is made to find one substance. Monoclonal antibodies are being used to treat some types of cancer and are being studied in the treatment of other types. They can be used alone or to carry drugs, toxins, or radioactive materials directly to a tumor.

A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with the standard of care. Also called best practice and standard therapy.

A substance made by cells that stimulates new blood vessel formation. Also called VEGF.