This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic hormone-refractory prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

Eligibility Criteria

You may be eligible to participate in this clinical trial if you fit the following criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Progressive, metastatic hormone-refractory prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant)
• Progressive disease based on PSA progression, scans, or positive bone scan
• ECOG zero or one

Exclusion Criteria

• Prior treatment with sunitinib and/or more than one prior chemotherapy regimen in the metastatic disease setting
• Chemotherapy within three weeks
• Impending complications from bone metastases
• Ongoing urinary obstruction
• Cardiac dysfunction, QTc >470 msec
• CNS involvement

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

Compensation

Participants will receive no payment for participation, ideas, or products that may result from this study.

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