A Randomized, Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate: Evaluation Of Drug-Specific Biomarker Modulation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Celecoxib may be an effective treatment for early stage prostate cancer. It is not yet known if celecoxib is more effective than no treatment before surgery for prostate cancer.
PURPOSE: Randomized phase I trial to determine the effectiveness of celecoxib given before surgery to remove the prostate in treating patients who have localized prostate cancer.
详细描述
OBJECTIVES:
- Compare biomarker modulation (prostaglandin levels) in tissue samples of patients with localized prostate cancer treated with neoadjuvant celecoxib vs placebo followed by prostatectomy.
- Compare the effect of these regimens on angiogenic factors within the prostate in these patients.
- Determine the pharmacokinetic and pharmacodynamic effects of celecoxib in these patients.
- Compare the toxicity profiles of these regimens in these patients.
- Compare the compliance of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral neoadjuvant celecoxib twice daily.
- Arm II: Patients receive oral neoadjuvant placebo twice daily. Treatment in both arms continues for at least 4 weeks followed by prostatectomy.
Patients are followed within 1 month and then at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
Celecoxib
Participants receive celecoxib 400mg by mouth twice daily for 4 to 6 weeks prior to standard-of-care prostatectomy.
干预措施: celecoxib (Drug)
Placebo-control
Participants receive placebo for 4 to 6 weeks prior to standard-of-care prostatectomy.
干预措施: Placebos (Drug)