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 <=50
ng/dL

- Eastern Cooperative Oncology Group Performance Status of 0 to 2

- At least 4 weeks since an investigational agent prior to starting study therapy

- At least 8 weeks since radioisotope therapy prior to starting study therapy

- Recovery from any local therapy including surgery or radiation/radiotherapy for a
minimum of 7 days prior to starting study therapy

- Required initial laboratory values: white blood cell count >=3,000/mm^3; absolute
neutrophil count >=1,500/mm^3; platelet count >=100,000/mm^3; creatinine level
<=1.5*upper limit of normal (ULN); bilirubin <=ULN; aspartate aminotransferase
<=2.5*ULN; alanine aminotransferase <=2.5*ULN.

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.