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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00880672
First Posted: April 14, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Korean Urological Association
GlaxoSmithKline
Information provided by (Responsible Party):
Ja Hyeon Ku,, Seoul National University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 Ja Hyeon Ku,, Seoul National University Hospital:

Primary Outcome Measures:
  • HIF-1a and VEGF expression [ Time Frame: 2 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ja Hyeon Ku,, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00880672     History of Changes
Other Study ID Numbers: JHKu1
First Submitted: April 13, 2009
First Posted: April 14, 2009
Last Update Posted: October 12, 2017
Last Verified: April 2009

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

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Dutasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs