Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer
- Compare the overall survival and progression-free survival in patients with
hormone-refractory, metastatic adenocarcinoma of the prostate treated with docetaxel
and estramustine vs mitoxantrone and prednisone.
- Compare the qualitative and quantitative toxic effects of these regimens in this
- Compare the quality of life, including palliation of metastatic bone pain and global
quality of life, of patients treated with these regimens.
- Record prostate-specific antigen values for future correlations with response and
survival in patients treated with these regimens.
- Compare the responses in patients with bidimensionally measurable disease treated with
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease status (measurable or evaluable disease progression vs rising PSA only), NCI Common
Toxicity Criteria version 2.X pain scale (grade 2 or greater vs less than 2), and SWOG
performance status (0-1 vs 2-3). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV
over 1 hour on day 2.
- Arm II: Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone
twice daily on days 1-21.
Treatment in both arms repeats every 3 weeks for a maximum of 12 courses in the absence of
unacceptable toxicity or disease progression.
Quality of life is assessed at baseline, after courses 4 and 8, and then at 1 year after
Patients are followed every 6 months for 2 years and then annually for 1 year.
PROJECTED ACCRUAL: A total of 620 patients (310 per arm) will be accrued for this study
within 3.5 years.
Allocation: Randomized, Primary Purpose: Treatment
Daniel P. Petrylak, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Scottsdale Oncology Program||Scottsdale, Arizona 85259-5404|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|Mayo Clinic||Jacksonville, Florida 32224|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|CentraCare Health Plaza||Saint Cloud, Minnesota 56303|
|Altru Health System||Grand Forks, North Dakota 58201|