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

Benign Prostate Hyperplasia Clinical Trial

— ABSOLUTE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01736033
• Other study ID #: TMS1011
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 18, 2012
• Last updated: May 13, 2014
• Start date: February 2012
• Est. completion date: June 2017

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 545
• Est. completion date: June 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• Tamsulosin
1 tablet(0.2mg) orally q.d.
• Finasteride
1 tablet(5mg) orally q.d.
• Placebo
1 tablet(0.2mg) orally q.d.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang	Gyeoggi
Korea, Republic of	Bucheon St. Mary's Hospital	Bucheon	Gyeonggi
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon	Gyeonggi
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan	Chungnam
Korea, Republic of	Chungbuk National University Hospital	Cheongju	Chungbuk
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeonnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi
Korea, Republic of	Eulji General Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Astellas Pharma Korea, Inc., Medical Research Collaborating Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

Bosch JL, Kranse R, van Mastrigt R, Schröder 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. — View 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.

Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. — View 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. — View 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. — View Citation

Shapiro E, Lepor H. Pathophysiology of clinical benign prostatic hyperplasia. Urol Clin North Am. 1995 May;22(2):285-90. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	International Prostate Symptom Score(IPSS)		1 & 2 months after baseline, and then every 3 months up to 4 years	No
Secondary	International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form		every 6 months up to 4 years	No
Secondary	Uroflowmetry	including Qmax, voided volume and post-void residual volume(PVR)	every 6 months up to 4 years	No
Secondary	Prostate volume		every 1 year up to 4 years	No
Secondary	Global Response Assessment(GRA)		every 1 year up to 4 years	No
Secondary	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	Yes
Secondary	Blood Chemistry	including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin	every 1 year up to 4 years	Yes
Secondary	Adverse Events		every visit up to 4 years	Yes
Secondary	Physical examination	Digital Rectal Exam, Breast exam	every 1 year up to 4 years	Yes
Secondary	Male Sexual Health Questionnaire		every 6 months up to 4 years	Yes