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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Astellas Pharma Korea, Inc.
Medical Research Collaborating Center, Seoul, Korea
Information provided by (Responsible Party):
Soo Woong Kim, MD, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01736033
First received: November 18, 2012
Last updated: May 13, 2014
Last verified: May 2014
  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:


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 ]

Enrollment: 545
Study Start Date: February 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: February 2017 (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 ≤ 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736033

Locations
Korea, Republic of
Chungbuk National University Hospital
Cheongju, Chungbuk, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungnam, Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Gyeoggi, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
Bucheon, Gyeonggi, Korea, Republic of
Bucheon St. Mary's Hospital
Bucheon, Gyeonggi, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of
Ajou University Hospital
Suwon, Gyeonggi, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Jeonnam, Korea, Republic of
Pusan National University Hospital
Busan, Korea, Republic of
Eulji General Hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
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:
Responsible Party: Soo Woong Kim, MD, 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: May 13, 2014
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Urological Manifestations
Signs and Symptoms
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
Urological Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Antagonists

ClinicalTrials.gov processed this record on August 26, 2014