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

This study has been completed.
Sponsor:
Collaborators:
The Korean Urological Association
GlaxoSmithKline
Information provided by (Responsible Party):
Ja Hyeon Ku,, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00880672
First received: April 13, 2009
Last updated: June 10, 2013
Last verified: April 2009
  Purpose

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).


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: dutasteride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • HIF-1a and VEGF expression [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    effects of dutasteride on the expression of angiogenesis markers in rat and human prostates


Enrollment: 40
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dutasteride
oral, 5mg, once per day, 2 weeks
Drug: dutasteride
5mg, oral, daily, 2-4 weeks
Placebo Comparator: placebo
oral, 5mg, once per day, 2 weeks

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  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: NCT00880672

Sponsors and Collaborators
Seoul National University Hospital
The Korean Urological Association
GlaxoSmithKline
Investigators
Principal Investigator: Jae-Seung paick, MD, PhD Dept. of Urology, Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Ja Hyeon Ku,, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00880672     History of Changes
Other Study ID Numbers: JHKu1
Study First Received: April 13, 2009
Last Updated: June 10, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
prostate, dutasteride
vascular endothelial growth factor
hypoxia inducible factor

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014