A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 78
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare the survival of patients with high-risk hormone-naive prostate cancer treated with androgen blockade with concurrent chemotherapy vs delayed chemotherapy.
Secondary
- Compare biochemical control in patients treated with these regimens.
- Determine the toxicity of these regimens in these patients.
- Compare the time to clinical failure, as measured by progression on bone scan or CT scan or a prostate-specific antigen (PSA) doubling time of ≤ 32 weeks, in patients treated with these regimens.
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
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
干预措施: flutamide (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
干预措施: vinblastine sulfate (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
干预措施: flutamide (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
干预措施: bicalutamide (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
干预措施: docetaxel (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
干预措施: doxorubicin hydrochloride (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
干预措施: estramustine phosphate sodium (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
干预措施: ketoconazole (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
干预措施: paclitaxel (Drug)
Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
干预措施: releasing hormone agonist therapy (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
干预措施: bicalutamide (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
干预措施: docetaxel (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
干预措施: doxorubicin hydrochloride (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
干预措施: estramustine phosphate sodium (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
干预措施: ketoconazole (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
干预措施: paclitaxel (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
干预措施: releasing hormone agonist therapy (Drug)
Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
干预措施: vinblastine sulfate (Drug)
结局指标
主要结局
Overall Survival
时间窗: From date of randomization to the date of death due to any cause
次要结局
- Time to Clinical Failure(Time from study entry to positive scan or positive disease evaluation of the pelvis or chest or a PSA doubling time ≤ 32 weeks)
- Biochemical control(From date of randomization to the date of first PSA failure defined as a PSA doubling time <= 32 weeks)
- Frequency of non-hematologic (>= grade 3), hematologic (grade >=4) and fatal (grade 5) toxicities(From the beginning of treatment to 90 days post treatment)