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Benign Prostate HyperplasiaPhase 4ABSOLUTENCT01736033

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

A Phase 4 study testing Tamsulosin and Finasteride in people with Benign Prostate Hyperplasia, run by Seoul National University Hospital at 11 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Benign Prostate Hyperplasia
What is being tested?
Tamsulosin and Finasteride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
545 participants
Where
11 sitesSouth Korea
Study dates
Feb 2012to Jun 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 15Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

South Korea11 sites

  • Hallym University Sacred Heart Hospital

    Anyang, Gyeoggi

  • Bucheon St. Mary's Hospital

    Bucheon-si, Gyeonggi-do

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, Gyeonggi-do

  • Pusan National University Hospital

    Busan

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan, Chungcheongnam-do

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do

  • Seoul National University Hospital

    Seoul, 110-744

  • Eulji General Hospital

    Seoul

  • Ajou University Hospital

    Suwon, Gyeonggi-do

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Tamsulosin, Finasteride, Placebo
Keywords
Lower Urinary Tracts Symptoms, 5 alpha reductase inhibitor, Proscar, Finasteride, alpha blocker, Tamsulosin, Harnal D
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TamsulosinDrug

    Also called Harnal D (brand name in Asia), Flomax

    1 tablet(0.2mg) orally q.d.

  • FinasterideDrug

    Also called Proscar

    1 tablet(5mg) orally q.d.

  • PlaceboDrug

    1 tablet(0.2mg) orally q.d.

Study groups in NCT01736033
Study groupRoleWhat they receive
Tamsulosin + PlaceboPlacebo comparatorTamsulosin 0.2mg + Placebo 5 mg daily until clinical progression
Receives: Drug: Tamsulosin; Drug: Placebo
Tamsulosin + FinasterideActive comparatorTamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression
Receives: Drug: Tamsulosin; Drug: Finasteride

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 & 2 months after baseline, and then every 3 months up to 4 years

Secondary outcomes (10)

  1. International Prostate Symptom Score(IPSS)

    Measured: 1 & 2 months after baseline, and then every 3 months up to 4 years

  2. International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form

    Measured: every 6 months up to 4 years

  3. Uroflowmetry

    including Qmax, voided volume and post-void residual volume(PVR)

    Measured: every 6 months up to 4 years

  4. Prostate volume

    Measured: every 1 year up to 4 years

  5. Global Response Assessment(GRA)

    Measured: every 1 year up to 4 years

  6. 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.

    Measured: every 1 year up to 4 years

  7. Blood Chemistry

    including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin

    Measured: every 1 year up to 4 years

  8. Adverse Events

    Measured: every visit up to 4 years

  9. Physical examination

    Digital Rectal Exam, Breast exam

    Measured: every 1 year up to 4 years

  10. Male Sexual Health Questionnaire

    Measured: every 6 months up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionFeb 2017 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
545 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01736033
Sponsor's protocol ID
TMS1011
Acronym
ABSOLUTE
Status last verified
May 2014
First submitted
18 Nov 2012
Last updated
14 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

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

    PubMed 7539174

  • 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.

    PubMed 1714529

  • 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.

    PubMed 7532234

  • 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.

  • 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.

  • 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.

    PubMed 2462301

  • 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.

    PubMed 9117115

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tamsulosin and Finasteride in people with Benign Prostate Hyperplasia, run by Seoul National University Hospital at 11 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Progression (time frame: 1 & 2 months after baseline, and then every 3 months up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01736033, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.

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