Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers
- Compare 36-month overall survival of patients with metastatic prostate adenocarcinoma
treated with hormonal therapy and docetaxel vs hormonal therapy alone.
- Compare 24-month progression-free survival (biological progression and/or clinical
progression) in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare costs of these regimens for these patients.
- Compare the tolerability of these regimens in these patients.
- Compare the toxicity profile of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- Arm I: Patients receive hormonal therapy comprising 1 of the following: goserelin alone
OR goserelin and antiandrogen therapy OR surgical castration. Hormonal therapy
continues until the development of hormone resistance. Within 2 months after initiation
of hormonal therapy, patients receive docetaxel IV every 3 weeks for up to 9 courses in
the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive hormonal therapy as in arm I. Quality of life is assessed.
PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Overall survival at 36 months
Gwenaelle Gravis, MD
United States: Federal Government