A Randomized Double Blind, Placebo-controlled Study Determining the Role of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Rate of biochemical recurrence
研究概览
简要总结
Biochemical recurrence develops in approximately 30-40% of men with locally advanced prostate cancer who undergo radical prostatectomy. To date, the effect of statins on prostate cancer recurrence has been investigated in several retrospective studies with inconsistent results. The purpose of this study is to determine the impact of statin on biochemical recurrence after radical prostatectomy for locally advanced prostate cancer.
详细描述
Estimated Enrollment: 354
Study start date: October 2012
Estimated Study Completion Date: October 2015
Statin Group: Treatment with Atorvastatin 20mg daily after radical prostatectomy during 1 year.
Control Group: Treatment with Placebo daily after radical prostatectomy during 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must have correspond to one of the following three pathologic criteria.
- •A. Gleason scores 8 or greater B. Positive resection margin C. pT3-T4
- •Patients must have pathologically adenocarcinoma
- •Patients must be enrolled within 60 days after radical prostatectomy
- •Patients must be able to provide written informed consent
排除标准
- •Patients who have received neoadjuvant androgen deprivation therapy
- •Patients who have the participation of other clinical trial within the past 3 months
- •Patients who have treated with statin
- •Patients who have lymph node metastasis or distant metastasis
- •Patients who have 10 year risk of cardiovascular disease over 10% based on NCEP ATP III guideline.
研究组 & 干预措施
Atorvastatin 20mg
Atorvastatin 20mg daily for 1 year
干预措施: Atorvastatin 20mg (Drug)
Placebo
Placebo daily for 1 year
干预措施: Atorvastatin 20mg (Drug)
结局指标
主要结局
Rate of biochemical recurrence
时间窗: One year
次要结局
- Biochemical recurrence free survival(Five years)
研究者
In Gab Jeong, MD
professor
Asan Medical Center