Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 205
- 主要终点
- Number of Patients With Undetectable PSA
研究概览
简要总结
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate works in treating patients with prostate cancer who have undergone initial hormone therapy.
详细描述
OBJECTIVES:
Primary
- To assess the rate of achieving a prostate-specific antigen (PSA) of ≤ 0.2 ng/mL with abiraterone acetate therapy in men with metastatic prostate cancer with a sub-optimal response to androgen-deprivation therapy (ADT).
Secondary
- To assess the overall survival and objective progression-free survival of this group of patients.
- To assess PSA partial response.
- To evaluate the qualitative and quantitative toxicity of abiraterone acetate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
Abiraterone acetate + prednisone
Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily
Prednisone, 5 mg, oral, 5 mg twice daily
干预措施: abiraterone acetate (Drug)
Abiraterone acetate + prednisone
Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily
Prednisone, 5 mg, oral, 5 mg twice daily
干预措施: Prednisone (Drug)
结局指标
主要结局
Number of Patients With Undetectable PSA
时间窗: 12 months
undetectable PSA defined as \<= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.
次要结局
- Number of Patients With Toxicity of Abiraterone Acetate(Up to 3 years)
- Objective Progression-free Survival(3 years)
- Number of Patients With PSA Partial Response(12 months)
- Overall Survival(3 years)