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| Name | Class |
|---|---|
| Astellas Pharma Korea, Inc. | INDUSTRY |
| Medical Research Collaborating Center, Seoul, Korea | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin + Placebo | Placebo Comparator | Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression |
|
| Tamsulosin + Finasteride | Active Comparator | Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | 1 tablet(0.2mg) orally q.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Progression | One of below
| 1 & 2 months after baseline, and then every 3 months up to 4 years |
| 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 |
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Inclusion Criteria:
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
Other conditions considered not eligible for the trial upon investigator's judgement
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| Name | Affiliation | Role |
|---|---|---|
| Soo Woong Kim, M.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital Cheonan | Cheonan | Chungcheongnam-do | South Korea | |||
| Hallym University Sacred Heart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7539174 | Background | Shapiro E, Lepor H. Pathophysiology of clinical benign prostatic hyperplasia. Urol Clin North Am. 1995 May;22(2):285-90. | |
| 1714529 | Background | Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. doi: 10.1016/0140-6736(91)90543-x. |
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| Finasteride | Drug | 1 tablet(5mg) orally q.d. |
|
|
| Placebo | Drug | 1 tablet(0.2mg) orally q.d. |
|
| 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 |
| Anyang |
| Gyeoggi |
| South Korea |
| Bucheon St. Mary's Hospital | Bucheon-si | Gyeonggi-do | South Korea |
| Soon Chun Hyang University Hospital Bucheon | Bucheon-si | Gyeonggi-do | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | Jeollanam-do | South Korea |
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | South Korea |
| Pusan National University Hospital | Busan | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Eulji General Hospital | Seoul | South Korea |
| 7532234 | Background | Bosch JL, Kranse R, van Mastrigt R, Schroder FH. Reasons for the weak correlation between prostate volume and urethral resistance parameters in patients with prostatism. J Urol. 1995 Mar;153(3 Pt 1):689-93. doi: 10.1097/00005392-199503000-00039. |
| Background | Chung TG, Chung J, Lee MS, Ahn H. Prevalence of benign prostatic hyperplasia in Jeong-Eup Area: community-based study. Korean J Urol 1999;40:52-8. |
| Background | The prevalence of benign prostatic hyperplasia in elderly men in Korea: a community-based study. Park HK, Park H, Cho S, Bae J, Jeong S, Hong SK, et al. Korean J Urol 2009;50:843-7. |
| 2462301 | Background | Lepor H, Gup DI, Baumann M, Shapiro E. Laboratory assessment of terazosin and alpha-1 blockade in prostatic hyperplasia. Urology. 1988 Dec;32(6 Suppl):21-6. |
| 9117115 | Background | Noble AJ, Chess-Williams R, Couldwell C, Furukawa K, Uchyiuma T, Korstanje C, Chapple CR. The effects of tamsulosin, a high affinity antagonist at functional alpha 1A- and alpha 1D-adrenoceptor subtypes. Br J Pharmacol. 1997 Jan;120(2):231-8. doi: 10.1038/sj.bjp.0700907. |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| D018120 | Finasteride |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
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