Name of the Trial
Phase II Study of Cilengitide in Patients with Nonmetastatic Androgen-Independent Prostate Cancer (CCUM-2004-045). See the protocol summary at http://cancer.gov/clinicaltrials/CCUM-2004-045.

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."

Who Can Join This Trial
Researchers will enroll 32 men with confirmed prostate cancer diagnoses and rising PSA levels despite antiandrogen therapy. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/CCUM-2004-045. 

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://cancer.gov/clinicaltrials/CCUM-2004-045 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.