Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer
- Registration Number
- NCT00255606
- Lead Sponsor
- Tampere University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 360
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm II docetaxel 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. Arm I docetaxel 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 I prednisone 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 prednisone 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.
- Primary Outcome Measures
Name Time Method Time to treatment failure (TTF)
- Secondary Outcome Measures
Name Time Method Safety Response rate Use of epoetin beta Overall survival Quality of life every 6 weeks until TTF
Trial Locations
- Locations (18)
Keski-Pohjanmaa Central Hospital
🇫🇮Kokkola, Finland
Karolinska University Hospital - Solna
🇸🇪Stockholm, Sweden
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Mid-Western Cancer Centre at Mid-Western Regional Hospital
🇮🇪Limerick, Ireland
Kymenlaakso Central Hospital
🇫🇮Kotka, Finland
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Kainuu Central Hospital
🇫🇮Kajaani, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Satakunta Central Hospital
🇫🇮Pori, Finland
Bons Secours Hospital
🇮🇪Cork, Ireland
Turku University Central Hospital
🇫🇮Turku, Finland
Mercy University Hospital
🇮🇪Cork, Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
🇮🇪Dublin, Ireland
Beaumont Hospital
🇮🇪Dublin, Ireland
St. James's Hospital
🇮🇪Dublin, Ireland
Galway University Hospital
🇮🇪Galway, Ireland
Karlstad Central Hospital
🇸🇪Karlstad, Sweden