Clinical trial NCT01736033: Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Benign Prostate Hyperplasia
Keywords: Lower Urinary Tracts Symptoms
5 alpha reductase inhibitor
Proscar
Finasteride
alpha blocker
Tamsulosin
Harnal D
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Korea, Inc.
name: Medical Research Collaborating Center, Seoul, Korea
First posted: 2012-11-29
Enrollment: 545
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Progression
timeFrame: 1 & 2 months after baseline, and then every 3 months up to 4 years
Secondary outcomes:
measure: International Prostate Symptom Score(IPSS)
timeFrame: 1 & 2 months after baseline, and then every 3 months up to 4 years
measure: International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form
timeFrame: every 6 months up to 4 years
measure: Uroflowmetry
timeFrame: every 6 months up to 4 years
measure: Prostate volume
timeFrame: every 1 year up to 4 years
measure: Global Response Assessment(GRA)
timeFrame: every 1 year up to 4 years
measure: PSA level
timeFrame: every 1 year up to 4 years
measure: Blood Chemistry
timeFrame: every 1 year up to 4 years
measure: Adverse Events
timeFrame: every visit up to 4 years
measure: Physical examination
timeFrame: every 1 year up to 4 years
measure: Male Sexual Health Questionnaire
timeFrame: every 6 months up to 4 years
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungbuk
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
state: Chungnam
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeoggi
city: Bucheon
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital
state: Gyeonggi
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
state: Gyeonggi
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonnam
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Soo Woong Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.