This clinical trial will test if the endothelin A receptor antagonist ZD4054 can further improve survival compared with docetaxel alone.

ZD4054 is a new type of agent that is thought to slow tumor growth by blocking endothelin A receptor activity. This trial will look at the effects of ZD4054 in hormone-resistant prostate cancer patients with bone metastases compared with docetaxel.

All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.

Half the patients will receive ZD4054, and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial, there is a 50 percent chance that patients will receive an agent that may further slow the progression of the tumor.

Eligibility

Patients may be eligible to participate in this trial if they meet the following criteria:

• Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)
• Increasing prostate-specific antigen (PSA) over a one month period
• Currently receiving treatment with surgical or medical castration

Exclusion Criteria

Patients who meet the following criteria are not eligible to participate in this trial:

• Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
• Suffering from heart failure or had a myocardial infarction within last six months
• A history of epilepsy or seizures

For more information, contact Karla Morris at 919-668-8375.