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

NCT01736033 | Unknown Phase 4 DMC

• 1 other identifier: TMS1011
• Study Type: interventional
• Target: 545
• Locations: 1 country
• Sites: 11

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.

Conditions

Benign Prostate Hyperplasia

Keywords

Lower Urinary Tracts Symptoms; 5 alpha reductase inhibitor; Proscar; Finasteride; alpha blocker; Tamsulosin; Harnal D

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

  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

Study Arms (2)

Tamsulosin + Placebo

PLACEBO COMPARATOR

Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression

Drug: Tamsulosin; Drug: Placebo

Tamsulosin + Finasteride

ACTIVE COMPARATOR

Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression

Drug: Tamsulosin; Drug: Finasteride

Interventions

Tamsulosin DRUG

1 tablet(0.2mg) orally q.d.

Also known as: Harnal D (brand name in Asia), Flomax

Tamsulosin + Finasteride; Tamsulosin + Placebo

Finasteride DRUG

1 tablet(5mg) orally q.d.

Also known as: Proscar

Tamsulosin + Finasteride

Placebo DRUG

1 tablet(0.2mg) orally q.d.

Tamsulosin + Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged over 50
• Clinically diagnosed benign prostate hyperplasia(BPH)
• ≤ IPSS ≤ 30
• ml/sec ≤ Q max ≤ 15 ml/sec
• minimum voided volume ≥ 125 ml
• Post voided residual volume ≤ 250
• Volunteer who singed on informed consent documents

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Astellas Pharma Korea, Inc.: collaborator
• Medical Research Collaborating Center, Seoul, Korea: collaborator

Study Sites (11)

Soon Chun Hyang University Hospital Cheonan

Cheonan, Chungcheongnam-do, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, Gyeoggi, South Korea

Location

Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Location

Pusan National University Hospital

Busan, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Eulji General Hospital

Seoul, South Korea

Location

Related Publications (7)

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

  PMID: 7539174 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.

  PMID: 1714529 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.

  PMID: 7532234 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.

  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.

  PMID: 2462301 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.

  PMID: 9117115 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin; Finasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Soo Woong Kim, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2012
• First Posted: November 29, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

KR (11)