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
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:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014