None listed
Conditions
Interventions
Group 1 Type of group
Docetaxel 75 mg / m every 3 weeks + prednisone 5 mg twice daily + dasatinib 100 mg per day
Group name:Group 2 Type of group
Docetaxel 75 mg / m every 3 weeks + prednisone 5 mg twice daily + placebo
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients must sign an informed consent stating that they have understood the investigative nature of the proposed treatment. • History of histologically diagnosed prostate cancer. • Evidence of metastatic disease by one of the following means: CT, MRI, bone scintigraphy or skeletal analysis. • Evidence of progression by any of the following means: Increasing PSA values ​​with at least 1 week difference and a final value> 2 ng / ml, or Progression of measurable ganglionic or visceral disease, or Two (2) or newer obvious lesions due to bone scintigraphy compared to a previous scintigraphy, or local recurrence in the prostate or prostate bed • Maintenance of castration status: patients who did not undergo surgical orchiectomy should have received and continued medical treatments [such as gonadotropin-releasing hormone analogues (GnRH analogues)] to maintain castration levels in serum testosterone <50 ng / dl (1.7 nmol / 1). • General status ECOG 0-2. • At least 4 weeks after major surgery, radiation therapy and a research agent. • At least 8 weeks after a radioisotope treatment (for example, strontium 89, samarium 153 or similar agents) • Recovery of local primary treatment by surgery or radiation. • Only men at least 18 years of age.
Exclusion criteria
Exclusion criteria: • Women. • Sexually active fertile men who do not use an effective contraceptive method if their partners are women of childbearing age. • Patients with active brain or leptomeningeal metastases will be excluded from this study. • Clinically significant cardiovascular diseases, including myocardial infarction or ventricular tachyarrhythmia within a period of 6 months, prolonged QTc> 450 msec, ejection fraction (EF) 2. • Patients with a second currently active malignant cancer that is not nonmelanoma skin cancer will not be included in the study. Patients will not be considered to have a currently active malignant disease if they have finished a treatment and their doctor currently considers that they have less than 30% risk of recurrence. • Concurrent uncontrolled disease, such as continuous or active infection, cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with the study requirements. • HIV positive patients receiving combined antiretroviral treatment. • History of allergic reactions attributed to compounds of chemical or biological composition similar to that of the agents under investigation. • Patients cannot receive any other investigating agent for prostate cancer. • Patients should not have previously received cytotoxic chemotherapy for metastatic disease, with the exception of estramustine. • Patients may continue taking daily multivitamins, but all dietary, alternative or herbal supplements (such as PC-Spes, serenoa rapens (dwarf palm), St. John´s Wort, etc.) should be discontinued before entering the study. • Ketoconazole should be discontinued four weeks before starting the study treatment. • Antiandrogens should be discontinued before beginning study treatment. Patients with a history of antiandrogen response and subsequent progression with the administration of the same agent should undergo controls to detect responses that would withdraw them from the study for 4 weeks. This control will not be necessary for patients who have never responded to antiandrogens. • Do not start taking bisphosphonates within 28 days before the start of the study treatment. • QT interval prolongation agents associated with Torsade de Pointes arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Overall survival is defined as time in months from the randomization date to the date of death due to any cause (in the randomized population). If the patient did not die, survival was censored on the last date he or she was known to be alive. Measure:Overall Survival Timepoints:From randomization to death or date of last contact (maximum reached: 45 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Objective tumor response rate=the percentage of randomized participants with a best tumor response of partial (PR) or complete response (CR), within 42 days of end of dosing, divided by total number of patients who were evaluable (with at least 1 target lesion at baseline). By RECIST: CR=disappearance of clinical and radiologic evidence of target and nontarget lesions confirmed by another evaluation at least 6 weeks later. PR=a >30% or greater decrease in the sum of longest diameter (LD) of target lesions in reference to the baseline sum LD confirmed by another evaluation at least 6 weeks later. Stable disease=neither sufficient increase to qualify for PD nor shrinkage to qualify for PR, and at least 8 weeks since start of study therapy. Progressive disease=a 20% or greater increase in sum of LD of all target lesions, taking as reference the smallest sum of LD at or following baseline, or unequivocal progression on existing nontarget lesions, or new lesions are present. Measure:Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST) Timepoints:At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing) ; Outcome name:Time to first SRE is defined as the time in months from the date of randomization to the date of first SRE (unless SRE occurred while the patient was undergoing subsequent cancer therapy). Participants with a first SRE while on subsequent cancer therapy, those who died without a reported SRE, and those who did not have an SRE were censored on the date of their last SRE assessment prior to start of subsequent cancer therapy, if any. Participants who had no SRE assessments were censored on the day they were randomized. Measure:Time to First Skeletal-related Event (SRE) Timepoints:From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer th | — |
Countries
Argentina, Australia, Brazil, Canada, Czech Republic, Finland, France, Germany, Hungary, India, Ireland, Italy, Korea South, Mexico, Norway, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, United Kindgdom, United States
Contacts
Public Contactursula noto
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed