A Multicenter, Randomized, Double-blind, Clinical Study to Investigate the Efficacy and Safety of Treatment With Tamsulosin 0.2mg Mono and Tamsulosin 0.2mg, Finasteride 5mg Combination Therapy in Patients With LUTS/BPH
试验速览
- 阶段
- 4 期
- 入组人数
- 545
- 试验地点
- 11
- 主要终点
- Clinical Progression
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate hyperplasia patients, and suggest guidelines of the combination therapy.
详细描述
Even though it should be decided on patients cautiously under careful consideration about prostate volume, Prostate Specific Antigen(PSA) level, symptom score and maximum uroflow, recently the combination therapy of alpha-blocker and 5-alpha reductase inhibitor has been tried imprudently in Korea.
As a result of several clinical trials which had conducted overseas for releasing the combination drug of alpha-blocker and 5-alpha reductase inhibitor, the superiority of the combination therapy has been proved, however, plenty of patients still don't derive additional profit from it.
Therefore, in this study, the investigators anticipate to meet with meaningful results on the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in Korean benign prostate hyperplasia patients, and provide guidelines of the combination therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged over 50
- •Clinically diagnosed benign prostate hyperplasia(BPH)
- •8 ≤ IPSS ≤ 30
- •4 ml/sec ≤ Q max ≤ 15 ml/sec
- •minimum voided volume ≥ 125 ml
- •Post voided residual volume ≤ 250
- •Volunteer who singed on informed consent documents
排除标准
- •Past history of surgical procedure experience related to BPH
- •Past history of taking 5-alpha reductase inhibitor(5-ARI) within 6 months before screening, or for more than 12 months regardless of the point of time
- •Past history of taking alpha blocker within 2 weeks before screening
- •Past history of acute urinary retention within 3 months before screening
- •Serum PSA ≥ 10 ng/ml (but, in the case of 4 ng/ml ≤ PSA < 10 ng/ml, the patients can be included only if prostate cancer is excluded by prostate biopsy)
- •Anatomical abnormalities of lower urinary tracts(urethrostenosis, diverticulosis, bladder neck contracture)
- •Clinical status that affects voiding other than BPH(neurogenic bladder, Chronic Prostatitis/Chronic Pelvic Pain Syndrome, urinary infection, etc.)
- •Unstable and significant medical condition including below
- •Unstable angina pectoris, myocardial infarction, cerebrovascular disease within 6 months before screening
- •Past history of malignant tumor including skin basal cell carcinoma within 5 years before screening
- •Medically uncontrollable diabetes mellitus, peptic ulcer disease
- •Severe hepatic diseases
- •Past history of renal failure or renal disease (serum creatinine > 1.4mg/dl)
- •Condition expected serious adverse event due to the investigational drug
- •Other conditions considered not eligible for the trial upon investigator's judgement
研究组 & 干预措施
Tamsulosin + Placebo
Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression
干预措施: Tamsulosin (Drug)
Tamsulosin + Placebo
Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression
干预措施: Placebo (Drug)
Tamsulosin + Finasteride
Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression
干预措施: Tamsulosin (Drug)
Tamsulosin + Finasteride
Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression
干预措施: Finasteride (Drug)
结局指标
主要结局
Clinical Progression
时间窗: 1 & 2 months after baseline, and then every 3 months up to 4 years
One of below * Deterioration of the symptoms * Acute urinary retention * Renal failure * Recurrent urinary tract infection * Urinary incontinence * Surgical procedure related to benign prostate hyperplasia
次要结局
- Uroflowmetry(every 6 months up to 4 years)
- Global Response Assessment(GRA)(every 1 year up to 4 years)
- Adverse Events(every visit up to 4 years)
- Physical examination(every 1 year up to 4 years)
- Male Sexual Health Questionnaire(every 6 months up to 4 years)
- International Prostate Symptom Score(IPSS)(1 & 2 months after baseline, and then every 3 months up to 4 years)
- International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form(every 6 months up to 4 years)
- Prostate volume(every 1 year up to 4 years)
- PSA level(every 1 year up to 4 years)
- Blood Chemistry(every 1 year up to 4 years)
研究者
Soo Woong Kim, MD
Principal Investigator
Seoul National University Hospital