MedPath

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

Phase 4
Completed
Conditions
Benign Prostatic Hyperplasia
Interventions
Registration Number
NCT00880672
Lead Sponsor
Seoul National University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
40
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
dutasteridedutasterideoral, 5mg, once per day, 2 weeks
Primary Outcome Measures
NameTimeMethod
HIF-1a and VEGF expression2 weeks

effects of dutasteride on the expression of angiogenesis markers in rat and human prostates

Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath