A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial
- Compare the time to treatment failure in patients with hormone-refractory metastatic
prostate cancer treated with two different schedules of docetaxel in combination with
- 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
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.
Allocation: Randomized, Primary Purpose: Treatment
Time to treatment failure (TTF)
Tampere University Hospital
United States: Federal Government