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.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

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.

Criterios de exclusión

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.

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Caba, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Ramos Mejía, Buenos Aires, Argentina

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Cipolletti, Río Negro Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution

Cordaba, Argentina

A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Placebo

Dasatinib

Docetaxel

Prednisone

Ubicaciones

Local Institution

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Patrocinadores