NCT00186108已完成1 期
A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response.
研究概览
简要总结
The primary purpose of this study is to evaluate the ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response. Secondary goals are to describe the safety and tolerability at this dose and schedule, to determine the time to sustained biochemical response, to determine the duration of biochemical response, to determine the time to disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Histologically documented adenocarcinoma of prostate
- •Currently receiving LHRH agonists with castrate levels of testosterone or who have had an orchiectomy
- •Must have had a rise in PSA despite anti androgen withdrawal
- •Exhibit 2 consecutive rise in PSA after the last hormonal manipulation
- •Minimum PSA of greater than 5 KPS greater than 80%
- •Normal cortisol level at entry
- •Life expectancy greater than 6 months
- •Provide written consent pursuant to regulatory requirements prior to initiation of study procedure
- •Exclusion criteria:
- •Younger than 18 years
- •Patients without prostate cancer
排除标准
- 未提供
结局指标
主要结局
Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response.
时间窗: Following treatment
次要结局
- Safety and tolerability at this dose and schedule, time to sustained biochemical response, duration of biochemical response, time to disease progression(Following treatment)
研究者
研究点 (2)
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