Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 900
- 试验地点
- 4
- 主要终点
- Time to loss of androgen-dependence, based on serum prostate-specific antigen (PSA) failure according to protocol definition
研究概览
简要总结
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as cyproterone acetate may stop the adrenal glands from making androgens. Sometimes the tumor may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving cyproterone acetate continuously is more effective than giving cyproterone acetate after tumor progression in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying cyproterone acetate to compare how well it works when given continuously or after tumor progression in treating patients with newly diagnosed stage III or stage IV prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare time to loss of androgen dependence, based on serum prostate-specific antigen failure, in patients with newly diagnosed stage III or IV prostate cancer treated with intermittent vs continuous androgen suppression comprising cyproterone acetate.
- Compare time to treatment failure (subjective or objective progression) in patients treated with these regimens.
- Compare quality of life of patients treated with these regimens.
- Compare survival of patients treated with these regimens.
Secondary
- Compare the side effects in patients treated with these regimens.
- Determine the first and total therapy-free intervals in patients treated with intermittent cyproterone acetate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 79 Years（Child, 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
结局指标
主要结局
Time to loss of androgen-dependence, based on serum prostate-specific antigen (PSA) failure according to protocol definition
Time to treatment failure (subjective or objective progression)
Quality of life
Survival
次要结局
- Side effects
- First and total therapy-free intervals in patients treated with intermittent cyproterone acetate