Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Tampere University
OBJECTIVES: Primary * Compare the time to treatment failure in patients with hormone-refractory metastatic prostate cancer treated with two different schedules of docetaxel in combination with prednisone. Secondary * Compare overall survival of patients treated with these regimens. * Compare the response rate in patients treated with these regimens. * Compare the safety of these regimens in these patients. * Compare the quality of life of patients treated with these regimens. * Compare the need for epoetin beta in patients treated with these regimens. * Determine the effect of epoetin beta on hemoglobin response rate, transfusion rate, and quality of life of patients treated with these regimens. OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive docetaxel IV over 1 hour on days 1 and 15 and oral prednisone once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive docetaxel IV over 1 hour on day 1 and prednisone once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience anemia (hemoglobin \< 11 g/dL) receive epoetin beta subcutaneously once weekly during chemotherapy. Quality of life is assessed at baseline, every 6 weeks during study treatment, at completion of study treatment, and then every 2 months thereafter. After completion of study treatment, patients are followed every 2 months. PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this study within 4 years.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
