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

This study is currently recruiting participants.
Verified November 2012 by Seoul National University Hospital
Sponsor:
Collaborators:
Astellas Pharma Korea, Inc.
Medical Research Collaborating Center, Seoul, Korea
Information provided by (Responsible Party):
Soo Woong Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01736033
First received: November 18, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Benign Prostate Hyperplasia
 Drug: Tamsulosin
Drug: Finasteride
Drug: Placebo
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Clinical Progression [ Time Frame: 1 & 2 months after baseline, and then every 3 months up to 4 years ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • International Prostate Symptom Score(IPSS) [ Time Frame: 1 & 2 months after baseline, and then every 3 months up to 4 years ] [ Designated as safety issue: No ]
  • International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form [ Time Frame: every 6 months up to 4 years ] [ Designated as safety issue: No ]
  • Uroflowmetry [ Time Frame: every 6 months up to 4 years ] [ Designated as safety issue: No ]
    including Qmax, voided volume and post-void residual volume(PVR)

  • Prostate volume [ Time Frame: every 1 year up to 4 years ] [ Designated as safety issue: No ]
  • Global Response Assessment(GRA) [ Time Frame: every 1 year up to 4 years ] [ Designated as safety issue: No ]
  • PSA level [ Time Frame: every 1 year up to 4 years ] [ Designated as safety issue: Yes ]
    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.

  • Blood Chemistry [ Time Frame: every 1 year up to 4 years ] [ Designated as safety issue: Yes ]
    including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin

  • Adverse Events [ Time Frame: every visit up to 4 years ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: every 1 year up to 4 years ] [ Designated as safety issue: Yes ]
    Digital Rectal Exam, Breast exam

  • Male Sexual Health Questionnaire [ Time Frame: every 6 months up to 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 556
Study Start Date: February 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Tamsulosin + Placebo
Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression
 Drug: Tamsulosin
1 tablet(0.2mg) orally q.d.
Other Names:
  • Harnal D (brand name in Asia)
  • Flomax
Drug: Placebo
1 tablet(0.2mg) orally q.d.
Other Name: Placebo
Active Comparator: Tamsulosin + Finasteride
Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression
 Drug: Tamsulosin
1 tablet(0.2mg) orally q.d.
Other Names:
  • Harnal D (brand name in Asia)
  • Flomax
Drug: Finasteride
1 tablet(5mg) orally q.d.
Other Name: Proscar

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients aged over 50
  • Clinically diagnosed benign prostate hyperplasia(BPH)
  • 8 ≤ IPSS ≤ 30
  • 4 ml/sec ≤ Q max ≤ 30 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736033

Contacts
Contact: Soo Woong Kim, M.D. 82-2-2072-2426 swkim@snu.ac.kr

Locations
Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju, Chungbuk, Korea, Republic of
Contact: Yong Jun Kim, Ph.D.     82-43-269-6134     urokyj@cbnu.ac.kr    
Principal Investigator: Yong Jun Kim, Ph.D.            
Principal Investigator: Won Tae Kim            
Soon Chun Hyang University Hospital Cheonan Recruiting
Cheonan, Chungnam, Korea, Republic of
Contact: Youn Soo Jeon, Ph.D.     82-10-3477-9208     ysurol@schmc.ac.kr    
Principal Investigator: Youn Soo Jeon, Ph.D.            
Hallym University Sacred Heart Hospital Recruiting
Anyang, Gyeoggi, Korea, Republic of
Contact: Jin Seon Cho, Ph.D.            
Principal Investigator: Jin Seon Cho, Ph.D.            
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Gyeonggi, Korea, Republic of
Contact: Young-Ho Kim     82-10-2975-3262     yhkuro@schmc.ac.kr    
Principal Investigator: Young-Ho Kim, Ph.D.            
Bucheon St. Mary's Hospital Recruiting
Bucheon, Gyeonggi, Korea, Republic of
Contact: Joon-Chul Kim, M.D.     82-10-9105-6976     kjc@catholic.ac.kr    
Principal Investigator: Joon-Chul Kim, M.D.            
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of
Contact: Seok-Soo Byun, Ph.D.     82-31-787-7342     ssbyun@snubh.org    
Principal Investigator: Seok-Soo Byun, Ph.D.            
Ajou University Hospital Recruiting
Suwon, Gyeonggi, Korea, Republic of
Contact: Jong Bo Choi, Ph.D.     82-31-219-5273     urochoi@ajou.ac.kr    
Principal Investigator: Jong Bo Choi, Ph.D.            
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Jeonnam, Korea, Republic of
Contact: Seung Il Jung, Ph.D.     82-61-379-8160     drjsi@yahoo.co.kr    
Principal Investigator: Seung Il Jung, Ph.D.            
Pusan National University Hospital Recruiting
Busan, Korea, Republic of
Contact: Dong Gil Shin, Ph.D.     82-51-240-7351     shindong16@hanmail.net    
Principal Investigator: Dong Gil Shin, Ph.D.            
Eulji General Hospital Recruiting
Seoul, Korea, Republic of
Contact: Tag Geun Yoo, Ph.D.     82-10-4720-7172     ytk5202@eulji.ac.kr    
Principal Investigator: Tag Geun Yoo, Ph.D.            
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Soo Woong Kim, M.D.     82-2-2072-2426     swkim@snu.ac.kr    
Principal Investigator: Soo Woong Kim, M.D.            
Sponsors and Collaborators
Seoul National University Hospital
Astellas Pharma Korea, Inc.
Medical Research Collaborating Center, Seoul, Korea
Investigators
Principal Investigator: Soo Woong Kim, M.D. Seoul National University Hospital
  More Information

Publications:
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.

Responsible Party: Soo Woong Kim, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01736033     History of Changes
Other Study ID Numbers: TMS1011
Study First Received: November 18, 2012
Last Updated: November 27, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Lower Urinary Tracts Symptoms
5 alpha reductase inhibitor
Proscar
Finasteride
 5 alpha blocker
Tamsulosin
Flomax

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Adrenergic alpha-Antagonists
Tamsulosin
Finasteride
5-alpha Reductase Inhibitors
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Enzyme Inhibitors
Adrenergic alpha-1 Receptor Antagonists

ClinicalTrials.gov processed this record on May 23, 2013