Benign Prostate Hyperplasia
Conditions
Keywords
Lower Urinary Tracts Symptoms, 5 alpha reductase inhibitor, Proscar, Finasteride, alpha blocker, Tamsulosin, Harnal D
Brief summary
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
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.
Interventions
DRUGTamsulosin
1 tablet(0.2mg) orally q.d.
DRUGFinasteride
1 tablet(5mg) orally q.d.
DRUGPlacebo
1 tablet(0.2mg) orally q.d.
Sponsors
Astellas Pharma Korea, Inc.
Medical Research Collaborating Center, Seoul, Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Progression | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form | every 6 months up to 4 years | — |
| Uroflowmetry | every 6 months up to 4 years | including Qmax, voided volume and post-void residual volume(PVR) |
| Prostate volume | every 1 year up to 4 years | — |
| Global Response Assessment(GRA) | every 1 year up to 4 years | — |
| International Prostate Symptom Score(IPSS) | 1 & 2 months after baseline, and then every 3 months up to 4 years | — |
| Blood Chemistry | every 1 year up to 4 years | including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin |
| Adverse Events | every visit up to 4 years | — |
| Physical examination | every 1 year up to 4 years | Digital Rectal Exam, Breast exam |
| Male Sexual Health Questionnaire | every 6 months up to 4 years | — |
| PSA level | every 1 year up to 4 years | 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. |
Countries
South Korea
Outcome results
None listed