Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
研究概览
简要总结
Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups: dutasteride treatment group and watchful waiting strategy group. According to the study protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after randomization.
There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age - 40-80 years
- •HPIN on prostate biopsy specimens
- •PSA below 20ng/ml
- •No hormone therapy or radiation in pelvic region
- •No previous treatment with 5alfa reductase inhibitors
- •Signed Subject Information and Informed Subject Consent Form.
排除标准
- •Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
研究组 & 干预措施
dutasteride
treatment group
干预措施: dutasteride (Drug)
dutasteride
treatment group
干预措施: prostate biopsy (Procedure)
watchful waiting strategy
干预措施: prostate biopsy (Procedure)
结局指标
主要结局
rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
时间窗: 6, 12, 24, and 36 months
次要结局
- effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).(6, 12, 24, and 36 months)
研究者
Stasys Auskalnis
doctor
Lithuanian University of Health Sciences