Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH
2021年8月21日 更新者：Kyo Chul Koo、Gangnam Severance Hospital
A Prospective, Randomized, Open Label, Parallel Trial Comparing the Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With Benign Prostatic Hyperplasia
The investigators compare the efficacy of alpha-blocker and 5-ARI withdrawal to continued combination therapy on the maintenance of LUTS and improvement of quality of life outcomes in men with benign prostatic hyperplasia.
研究概览
地位
招聘中
详细说明
Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms (LUTS). Combination therapy with an alpha-blocker and 5α reductase inhibitors (5-ARI) is the first-line treatment of BPH-related LUTS for the reduction of the size of the prostate and LUTS improvement. Combination therapy is tolerated well by most men; however, the incidence of adverse events is higher than with either therapy alone. In patients with improved LUTS following combination therapy, the aim of this study is based on the hypothesis that the withdrawal of either therapy will not increase the risk of LUTS aggravation while improving the quality of life.
The investigators plan a prospective, randomized, open-label, parallel trial, comparing alpha-blocker withdrawal and 5-ARI withdrawal to continued combination therapy. Treatments will be allocated in a 1:1:1 ratio, based on IPSS score (≤30% decrease from baseline) and prostate volume (≤35% decrease from baseline).
研究类型
介入性
注册 (预期的)
300
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kyo Chul Koo, MD, PhD
- 电话号码：82-01099480342
- 邮箱：gckoo@yuhs.ac
研究联系人备份
- 姓名：Kwang Suk Lee, MD, MMS
- 电话号码：82-01089246674
- 邮箱：calmenow@yuhs.ac
学习地点
-
-
-
Seoul、大韩民国、135-720
- 招聘中
- Gangnam Severance Hospital, Yonsei University College of Medicine
-
接触：
- Kyo Chul Koo, MD, PhD
- 电话号码：82-01099480342
- 邮箱：gckoo@yuhs.ac
-
接触：
- Kwang Suk Lee, MD, MMS
- 电话号码：82-01089246674
- 邮箱：calmenow@yuhs.ac
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Men aged ≥50 or <80 years AND
- On combination therapy (alpha-blocker and 5-ARI) ≥12 months AND
- IPSS score (≤30% decrease from baseline) AND
- Prostate volume (≤35% decrease from baseline)
Exclusion Criteria:
- Suspected prostate cancer (PSA density >0.15 ng/ml/cc) requiring specific management
- On-going prostatitis or urinary retention
- Acontractile detrusor
- Neurogenic lower urinary tract dysfunction
- Urethral stenosis
- Patient unable or unwilling to provide written informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：alpha-blocker withdrawal
receives 5-ARI monotherapy
|
Withdrawal of either alpha-blocker or 5-ARI
其他名称：
|
|
实验性的：5-ARI withdrawal
receives alpha-blocker monotherapy
|
Withdrawal of either alpha-blocker or 5-ARI
其他名称：
|
|
有源比较器：combination therapy
receives alpha-blocker and 5-ARI
|
Maintenance of alpha-blocker and 5-ARI
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in International Prostate Symptom Score (IPSS) score from baseline
大体时间：18 months
|
IPSS is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst).
IPSS is self-administered at screening and each time-point of month 3, 6, 12, and 18.
Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia.
The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35).
Month 18 is the primary timepoint and earlier timepoints are considered secondary.
Change from baseline defined as difference between post-baseline value and baseline value.
|
18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of adverse events
大体时间：3, 6, 12, 18 months
|
Adverse events includes; dizziness, headache, pounding heartbeat, weakness.
decreased sexual desire, impotence, ejaculatory disorder, gynecomastia, depression, and anxiety.
|
3, 6, 12, 18 months
|
|
Change in International Prostate Symptom Score (IPSS) from baseline
大体时间：3, 6, 12 months
|
IPSS is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst).
IPSS is self-administered at screening and each time-point of month 3, 6, and 12. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia.
The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35).
Change from baseline defined as difference between post-baseline value and baseline value.
|
3, 6, 12 months
|
|
Change in Overactive bladder symptom score (OABSS) from baseline
大体时间：3, 6, 12, 18 months
|
The OABSS is a symptom assessment questionnaire designed to quantify OAB symptoms into a single score.
The questionnaire consists of 4 questions on OAB symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and UUI (5 points).
OABSS is self-administered at screening and each time-point of month 3, 6, 12 and 18. Change from baseline defined as difference between post-baseline value and baseline value.
|
3, 6, 12, 18 months
|
|
Change in EuroQol five dimension scale (EQ-5D) score from baseline
大体时间：3, 6, 12, 18 months
|
The EuroQol five dimension descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The EQ-5D is self-administered at screening and each time-point of month 3, 6, 12 and 18. Change from baseline defined as difference between post-baseline value and baseline value.
|
3, 6, 12, 18 months
|
|
Change in Qmax from baseline
大体时间：3, 12, 18 months
|
The measurement of maximum urinary flow rate (Qmax) is widely used in the assessment of men complaining of lower urinary tract symptoms.
Qmax is performed at screening and each time-point of month 3, 12, and 18. Change from baseline defined as difference between post-baseline value and baseline value.
|
3, 12, 18 months
|
|
Change in prostate volume from baseline
大体时间：18 months
|
The measurement of prostate volume is performed at screening and at month 18.
Change from baseline defined as difference between post-baseline value and baseline value.
|
18 months
|
|
Change in prostate-specific antigen (PSA) level from baseline
大体时间：18 months
|
The measurement of prostate-specific antigen (PSA) level is performed at screening and at month 18.
Change from baseline defined as difference between post-baseline value and baseline value.
|
18 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kyo Chul Koo, MD, PhD、Yonsei University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Barkin J, Guimaraes M, Jacobi G, Pushkar D, Taylor S, van Vierssen Trip OB. Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5alpha-reductase inhibitor dutasteride. Eur Urol. 2003 Oct;44(4):461-6. doi: 10.1016/s0302-2838(03)00367-1.
- Nickel JC, Barkin J, Koch C, Dupont C, Elhilali M. Finasteride monotherapy maintains stable lower urinary tract symptoms in men with benign prostatic hyperplasia following cessation of alpha blockers. Can Urol Assoc J. 2008 Feb;2(1):16-21. doi: 10.5489/cuaj.520.
有用的网址
- Finasteride monotherapy maintains stable lower urinary tract symptoms in men with benign prostatic hyperplasia following cessation of alpha blockers
- Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5alpha-reductase inhibitor dutasteride
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年12月8日
初级完成 (预期的)
2023年12月7日
研究完成 (预期的)
2023年12月7日
研究注册日期
首次提交
2021年8月15日
首先提交符合 QC 标准的
2021年8月21日
首次发布 (实际的)
2021年8月27日
研究记录更新
最后更新发布 (实际的)
2021年8月27日
上次提交的符合 QC 标准的更新
2021年8月21日
最后验证
2021年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 3-2020-0451 (其他赠款/资助编号：Handok Pharmaceutical)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
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