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NCT00880672 Clinical Trial

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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00880672
Other study ID # JHKu1
Secondary ID
Status Completed
Phase Phase 4
First received April 13, 2009
Last updated June 10, 2013
Start date January 2008
Est. completion date April 2009

Study information
Verified date April 2009
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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 information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• dutasteride
5mg, oral, daily, 2-4 weeks

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Seoul National University Hospital GlaxoSmithKline, The Korean Urological Association

Outcome
Type Measure Description Time frame Safety issue
Primary HIF-1a and VEGF expression effects of dutasteride on the expression of angiogenesis markers in rat and human prostates 2 weeks
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