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Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
dutasteride
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring prostate, dutasteride, vascular endothelial growth factor, hypoxia inducible factor

Eligibility Criteria

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

Inclusion Criteria:

  • informed consent
  • 50 years old or older
  • International Prostate Symptom Score (IPSS) >8
  • Maximum flow rate (Qmax) <15 ml/s
  • transurethral resection of the prostate (TURP)

Exclusion Criteria:

  • urethral catheter
  • urinary tract infection (UTI)
  • liver disease
  • renal disease
  • unexplained hematuria
  • prostate specific antigen (PSA) > 4ng/ml (included if prostate biopsy was negative)
  • interstitial cystitis
  • bladder cancer or prostate cancer
  • pelvic surgery or irradiation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    dutasteride

    placebo

    Arm Description

    oral, 5mg, once per day, 2 weeks

    oral, 5mg, once per day, 2 weeks

    Outcomes

    Primary Outcome Measures

    HIF-1a and VEGF expression
    effects of dutasteride on the expression of angiogenesis markers in rat and human prostates

    Secondary Outcome Measures

    Full Information

    First Posted
    April 13, 2009
    Last Updated
    June 10, 2013
    Sponsor
    Seoul National University Hospital
    Collaborators
    The Korean Urological Association, GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00880672
    Brief Title
    Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate
    Official Title
    Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    The Korean Urological Association, GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether dutasteride may influence the expression of angiogenesis factors such as hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF) in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).
    Detailed Description
    A total of 41 patients awaiting transurethral resection of the prostate (TURP) will be divided into two groups (1:1); twenty patients will receive no medication and 21 will receive 0.5 mg dutasteride daily for 2 to 4 weeks until TURP. In both groups, the extent, intensity and intracellular location of hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF)will be evaluated. Microvessel density will be also compared in the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia
    Keywords
    prostate, dutasteride, vascular endothelial growth factor, hypoxia inducible factor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    dutasteride
    Arm Type
    Active Comparator
    Arm Description
    oral, 5mg, once per day, 2 weeks
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    oral, 5mg, once per day, 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    dutasteride
    Intervention Description
    5mg, oral, daily, 2-4 weeks
    Primary Outcome Measure Information:
    Title
    HIF-1a and VEGF expression
    Description
    effects of dutasteride on the expression of angiogenesis markers in rat and human prostates
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: informed consent 50 years old or older International Prostate Symptom Score (IPSS) >8 Maximum flow rate (Qmax) <15 ml/s transurethral resection of the prostate (TURP) Exclusion Criteria: urethral catheter urinary tract infection (UTI) liver disease renal disease unexplained hematuria prostate specific antigen (PSA) > 4ng/ml (included if prostate biopsy was negative) interstitial cystitis bladder cancer or prostate cancer pelvic surgery or irradiation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jae-Seung paick, MD, PhD
    Organizational Affiliation
    Dept. of Urology, Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate

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