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Completed

NCT Number: NCT00880672

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

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).

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dutasteride

Drug

5mg, oral, daily, 2-4 weeks

Primary outcomes

  1. HIF-1a and VEGF expression

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • GlaxoSmithKline
  • The Korean Urological Association

Registry information

Official study title

Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Apr 14, 2009
Registry last updated
Jun 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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