NCT00078910已完成2 期
A Prospective Phase II Study of Preoperative, Controlled Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Apoptosis 4 weeks after completion of study as assessed by marker analysis (bcl-2, Bax, Par-4, M30, TUNEL assay, PTEN)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as exisulind, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant exisulind works in treating patients who are undergoing radical prostatectomy for stage II or stage III prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare the effect of neoadjuvant exisulind vs no neoadjuvant treatment on apoptosis in patients with stage II or III prostate cancer undergoing radical prostatectomy.
Secondary
- Determine the effect of this drug (preoperatively) on surrogate endpoint biomarkers (i.e., prostate-specific antigen, high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy) in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 40 Years 至 —（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
Apoptosis 4 weeks after completion of study as assessed by marker analysis (bcl-2, Bax, Par-4, M30, TUNEL assay, PTEN)
次要结局
- Modulation of other surrogate endpoint biomarkers (prostate-specific antigen high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy)
研究者
研究点 (6)
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