RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of docetaxel and prednisone is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and prednisone to compare how well they work in treating patients with metastatic prostate cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
Given in 3- or 4- week courses
Given in 3- or 4- week courses
Helsinki University Central Hospital
Helsinki, Finland
Kainuu Central Hospital
Kajaani, Finland
Time to treatment failure (TTF)
Quality of life every 6 weeks until TTF
Safety
Overall survival
Response rate
Use of epoetin beta
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TREATMENT
Enrollment
360
Keski-Pohjanmaa Central Hospital
Kokkola, Finland
Kymenlaakso Central Hospital
Kotka, Finland
Tampere University Hospital
Lahti, Finland
Oulu University Hospital
Oulu, Finland
Satakunta Central Hospital
Pori, Finland
Tampere University Hospital
Tampere, Finland
Turku University Central Hospital
Turku, Finland
Bons Secours Hospital
Cork, Ireland
...and 9 more locations