Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Benign Prostate Hyperplasia

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: Finasteride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Tamsulosin + Placebo<br>Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression | Drug: Tamsulosin<br>* 1 tablet(0.2mg) orally q.d.<br>* Other names: Flomax;Drug: Placebo<br>* 1 tablet(0.2mg) orally q.d.<br>|
| Active Comparator: Tamsulosin + Finasteride<br>Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression | Drug: Tamsulosin<br>* 1 tablet(0.2mg) orally q.d.<br>* Other names: Flomax;Drug: Finasteride<br>* 1 tablet(5mg) orally q.d.<br>* Other names: Proscar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Progression | 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 | 1 & 2 months after baseline, and then every 3 months up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Uroflowmetry | including Qmax, voided volume and post-void residual volume(PVR) | every 6 months up to 4 years | 
| Prostate volume |  | every 1 year up to 4 years | 
| Global Response Assessment(GRA) |  | every 1 year up to 4 years | 
| PSA level | PSA level will be examined in the central laboratory and be reported to each center as an adjusted number. It is because PSA level tends to decrease to 50% of baseline after taking finasteride for 1 4 years, so there is possibilities that the blindedness is broken with the actual result. | every 1 year up to 4 years | 
| Blood Chemistry | including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin | every 1 year up to 4 years | 
| Adverse Events |  | every visit up to 4 years | 
| Physical examination | Digital Rectal Exam, Breast exam | every 1 year up to 4 years | 
| Male Sexual Health Questionnaire |  | every 6 months up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower Urinary Tracts Symptoms, 5 alpha reductase inhibitor, Proscar, Finasteride, alpha blocker, Tamsulosin, Harnal D