search
Back to results

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

Primary Purpose

Benign Prostate Hyperplasia

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tamsulosin
Finasteride
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostate Hyperplasia focused on measuring Lower Urinary Tracts Symptoms, 5 alpha reductase inhibitor, Proscar, Finasteride, alpha blocker, Tamsulosin, Harnal D

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chungbuk National University Hospital
  • Soon Chun Hyang University Hospital Cheonan
  • Hallym University Sacred Heart Hospital
  • Bucheon St. Mary's Hospital
  • Soon Chun Hyang University Hospital Bucheon
  • Seoul National University Bundang Hospital
  • Ajou University Hospital
  • Chonnam National University Hwasun Hospital
  • Pusan National University Hospital
  • Seoul National University Hospital
  • Eulji General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Tamsulosin + Placebo

Tamsulosin + Finasteride

Arm Description

Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression

Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

International Prostate Symptom Score(IPSS)
International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form
Uroflowmetry
including Qmax, voided volume and post-void residual volume(PVR)
Prostate volume
Global Response Assessment(GRA)
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.
Blood Chemistry
including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin
Adverse Events
Physical examination
Digital Rectal Exam, Breast exam
Male Sexual Health Questionnaire

Full Information

First Posted
November 18, 2012
Last Updated
May 13, 2014
Sponsor
Seoul National University Hospital
Collaborators
Astellas Pharma Korea, Inc., Medical Research Collaborating Center, Seoul, Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT01736033
Brief Title
Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Astellas Pharma Korea, Inc., Medical Research Collaborating Center, Seoul, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostate Hyperplasia
Keywords
Lower Urinary Tracts Symptoms, 5 alpha reductase inhibitor, Proscar, Finasteride, alpha blocker, Tamsulosin, Harnal D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
545 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin + Placebo
Arm Type
Placebo Comparator
Arm Description
Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression
Arm Title
Tamsulosin + Finasteride
Arm Type
Active Comparator
Arm Description
Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Harnal D (brand name in Asia), Flomax
Intervention Description
1 tablet(0.2mg) orally q.d.
Intervention Type
Drug
Intervention Name(s)
Finasteride
Other Intervention Name(s)
Proscar
Intervention Description
1 tablet(5mg) orally q.d.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet(0.2mg) orally q.d.
Primary Outcome Measure Information:
Title
Clinical Progression
Description
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
Time Frame
1 & 2 months after baseline, and then every 3 months up to 4 years
Secondary Outcome Measure Information:
Title
International Prostate Symptom Score(IPSS)
Time Frame
1 & 2 months after baseline, and then every 3 months up to 4 years
Title
International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form
Time Frame
every 6 months up to 4 years
Title
Uroflowmetry
Description
including Qmax, voided volume and post-void residual volume(PVR)
Time Frame
every 6 months up to 4 years
Title
Prostate volume
Time Frame
every 1 year up to 4 years
Title
Global Response Assessment(GRA)
Time Frame
every 1 year up to 4 years
Title
PSA level
Description
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.
Time Frame
every 1 year up to 4 years
Title
Blood Chemistry
Description
including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin
Time Frame
every 1 year up to 4 years
Title
Adverse Events
Time Frame
every visit up to 4 years
Title
Physical examination
Description
Digital Rectal Exam, Breast exam
Time Frame
every 1 year up to 4 years
Title
Male Sexual Health Questionnaire
Time Frame
every 6 months up to 4 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Woong Kim, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju
State/Province
Chungbuk
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Cheonan
City
Cheonan
State/Province
Chungnam
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
State/Province
Gyeoggi
Country
Korea, Republic of
Facility Name
Bucheon St. Mary's Hospital
City
Bucheon
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeonnam
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Eulji General Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
7539174
Citation
Shapiro E, Lepor H. Pathophysiology of clinical benign prostatic hyperplasia. Urol Clin North Am. 1995 May;22(2):285-90.
Results Reference
background
PubMed Identifier
1714529
Citation
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.
Results Reference
background
PubMed Identifier
7532234
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
2462301
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.
Results Reference
background
PubMed Identifier
9117115
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs