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

Inclusion Criteria

• History of histologically diagnosed prostate cancer
• Evidence of metastatic disease by any 1 of the following: computed tomography scan, magnetic resonance imaging, bone scan, or skeletal survey
• Evidence of progression, as defined by 1 of the following: rising prostate specific antigen levels at least 1 week apart with the final value being >=2 ng/mL; progression of measurable nodal or visceral disease, with nodal lesions >=20 mm and visceral lesions measurable per response evaluation criteria for solid tumors (Response Evaluation in Solid Tumors, version 1); 2 or more lesions appearing on bone scan compared with previous scan; or local recurrence in the prostate or prostate bed
• Maintaining castrate status: Participants who have not undergone surgical orchiectomy should have received and continue on medical therapies, such as gonadotropin releasing hormone analogs, to maintain castrate levels of serum testosterone =3,000/mm^3; absolute neutrophil count >=1,500/mm^3; platelet count >=100,000/mm^3; creatinine level 450 msec; ejection fraction =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.