Trial Information

Summary: Phase III Study of Docetaxel and Atrasentan versus Docetaxel and Placebo For Patients with Advanced Hormone Refractory Prostate Cancer

The purpose of this study is to compare the effects (good and bad) of the combination of docetaxel and prednisone plus atrasentan against the combination of docetaxel and prednisone plus placebo on prostate cancer to see which is better.

This research is being done because many people think that the new combination of docetaxel and prednisone plus the investigational drug atrasentan may be better than the commonly used combination of docetaxel and prednisone alone, but these two treatments have not been compared. Atrasentan is an investigational drug. It has not been approved by the FDA for commercial use. We do not know which of these two treatments is better. We also want to find out how these two treatments affect quality of life.

Patient Inclusion Criteria:

• Metastatic Prostate Cancer Hormone refractory
• Age > 18 years
• Good performance status
• One prior chemotherapy is allowed
• Prior radiation is allowed
• No history of cancer in the last 5 years
• PSA wihtin 28 day of enrollment

Patient Exclusion Criteria:

• History of brain metastases
• Current major infection

Primary Outcomes: COmpare survival and progression free survival

If you would like to learn more about participating in this study, please send an e-mail message using the form below.