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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: dutasteride (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Jae-Seung paick, MD, PhD, Principal Investigator, Affiliation: Dept. of Urology, Seoul National University Hospital


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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: HIF-1a and VEGF expression

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.


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.


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

Locations and Contacts

Additional Information

Starting date: January 2008
Last updated: June 10, 2013

Page last updated: August 20, 2015

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