randomized study comparing docetaxel plus dasatinib to docetaxel plus placebo in castration-resistant prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.


Eligibility criteria:
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.