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

April 13, 2009
June 10, 2013
January 2008
December 2008   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00880672 on ClinicalTrials.gov Archive Site
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Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate
Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
Drug: dutasteride
5mg, oral, daily, 2-4 weeks
  • Active Comparator: dutasteride
    oral, 5mg, once per day, 2 weeks
    Intervention: Drug: dutasteride
  • Placebo Comparator: placebo
    oral, 5mg, once per day, 2 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2009
December 2008   (final data collection date for primary outcome measure)

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
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00880672
JHKu1
Yes
Ja Hyeon Ku,, Seoul National University Hospital
Seoul National University Hospital
  • The Korean Urological Association
  • GlaxoSmithKline
Principal Investigator: Jae-Seung paick, MD, PhD Dept. of Urology, Seoul National University Hospital
Seoul National University Hospital
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP