Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 385
- 试验地点
- 41
- 主要终点
- Treatment costs
研究概览
简要总结
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.
详细描述
OBJECTIVES:
- 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 treatment arms.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hormonotherapy + chemotherapy
干预措施: orchiectomy (Procedure)
Hormonotherapy + chemotherapy
干预措施: antiandrogen therapy (Drug)
Hormonotherapy + chemotherapy
干预措施: docetaxel (Drug)
Hormonotherapy + chemotherapy
干预措施: goserelin acetate (Drug)
Hormonotherapy alone
干预措施: antiandrogen therapy (Drug)
Hormonotherapy alone
干预措施: goserelin acetate (Drug)
Hormonotherapy alone
干预措施: orchiectomy (Procedure)
结局指标
主要结局
Treatment costs
Toxicity and tolerance
Overall survival at 36 months
Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays
Progression-free survival (biological progression and/or clinical progression) at 24 months
Quality of life
次要结局
未报告次要终点