Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer

Exclusion Criteria

• •Symptomatic brain metastases or leptomeningeal metastases
• •Clinically significant cardiovascular disease, including myocardial infarction; ventricular tachyarrhythmia within 6 months; prolonged QTc \>450 msec; ejection fraction \<40%; or major conduction abnormality, unless a cardiac pacemaker is present
• •Pleural or pericardial effusion of any Common Terminology Criteria (CTC) grade
• •Peripheral neuropathy CTC Grade \>=2
• •Currently active second malignancy other than nonmelanoma skin cancers. Participants are not considered to have a currently active malignancy if they have completed therapy and are now considered (by their physician) to be at less than 30% risk for relapse
• •Uncontrolled intercurrent illness including ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• •HIV infection-positive patients receiving combination antiretroviral therapy
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to the investigational agents
• •Receipt of any other investigational agents for the treatment of prostate cancer
• •Prior cytotoxic chemotherapy in the metastatic setting, with the exception of estramustine
• •Patients may continue on a daily multivitamin but must discontinue all other herbal, alternative, and food supplements before enrollment
• •Ketoconazole must be discontinued 4 weeks prior to starting study therapy
• •Antiandrogens must be discontinued prior to starting study therapy. Patients with a history of response to an antiandrogen and subsequent progression while on that antiandrogen should be assessed for antiandrogen withdrawal response for 4 weeks. Observation for antiandrogen withdrawal response is not necessary for those who have never responded to antiandrogens
• •Bisphosphonates must not be initiated within 28 days prior to starting study therapy
• •QT prolonging agents strongly associated with torsade de pointes.