Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- PSA Response
研究概览
简要总结
RATIONALE: Atorvastatin calcium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atorvastatin calcium together with celecoxib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving atorvastatin calcium together with celecoxib works in treating patients with rising PSA levels after local therapy for prostate cancer.
详细描述
OBJECTIVES:
Primary
- To determine the effect on the biological activity, as assessed by prostate-specific antigen (PSA) response, of atorvastatin calcium and celecoxib in patients with D0 prostate cancer.
Secondary
- To document the safety and feasibility of atorvastatin calcium and celecoxib in patients with early-stage prostate cancer.
- To evaluate the effects of the combination of atorvastatin calcium and celecoxib on nuclear factor-kB (NFkB), extracellular signal-regulated kinase (ERK), prostaglandin E2 (PGE2), and IL6 in peripheral blood mononuclear cells (PBMC).
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
Atorvastatin and Celecoxib
干预措施: atorvastatin calcium (Drug)
Atorvastatin and Celecoxib
干预措施: celecoxib (Drug)
Atorvastatin and Celecoxib
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
PSA Response
时间窗: 6 months
PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.
次要结局
未报告次要终点
研究者
Susan Goodin, PharmD
Professor of Medicine, RWJMS
Rutgers, The State University of New Jersey