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Name of the Trial

Phase II Study of Cilengitide in Patients with Nonmetastatic Androgen-Independent Prostate Cancer (CCUM-2004-045). See the protocol summary ³.

Principal Investigator

Dr. Maha Hussain Principal Investigator

Dr. Maha Hussain, University of Michigan Comprehensive Cancer Center.

Why This Trial Is Important

Prostate cancer usually responds initially to treatment that reduces the level of male hormones in the body (antiandrogen therapy). However, most prostate cancers eventually continue to grow despite hormone deprivation (androgen-independent prostate cancer).

Measuring the level of prostate-specific antigen (PSA) in the blood is often used to determine the response of prostate cancer to treatment. A rising PSA level may indicate that active cancer cells remain in the body despite previous treatments to remove or destroy them. Often, a rising PSA level is the only signal that prostate cancer is still growing (PSA-only progression).

In this trial, men with PSA-only progression despite antiandrogen therapy will be treated with a drug called cilengitide. Cilengitide blocks receptor proteins called integrins on the surface of prostate cancer cells that may play a role in the ability of these cells to enter and exit the bloodstream, attach at potential sites of metastasis, and promote the formation of new blood vessels (angiogenesis). PSA level stabilization or decline would indicate that cilengitide can help control prostate cancer growth in these patients.

"Men with this stage of advanced prostate cancer are incurable and no standard treatment exists," said Dr. Hussain. "Our hope is that cilengitide can help contain micrometastatic cancer cells by preventing their spread and adhesion to bone, which is the most common site of prostate cancer metastasis, and by stopping their potential to establish new blood vessels."

Contact Information

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

Glossary Terms

A substance that is being studied as an anticancer and antiangiogenesis drug. Also called EMD 121974.

Small numbers of cancer cells that have spread from the primary tumor to other parts of the body and are too few to be picked up in a screening or diagnostic test.

A protein made by the prostate gland and found in the blood. Prostate-specific antigen blood levels may be higher than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland. Also called PSA.

A molecule inside or on the surface of a cell that binds to a specific substance and causes a specific physiologic effect in the cell.

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