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).

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: dutasteride

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dutasteride; oral, 5mg, once per day, 2 weeks	Drug: dutasteride; 5mg, oral, daily, 2-4 weeks
Placebo Comparator: placebo; oral, 5mg, once per day, 2 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: GlaxoSmithKline; The Korean Urological Association
• Investigators: Principal Investigator: Jae-Seung paick, MD, PhD, Dept. of Urology, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: April 13, 2009
• First Submitted That Met QC Criteria: April 13, 2009
• First Posted (Estimate): April 14, 2009

Study Record Updates

• Last Update Posted (Estimate): June 12, 2013
• Last Update Submitted That Met QC Criteria: June 10, 2013
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: vascular endothelial growth factor; prostate, dutasteride; hypoxia inducible factor
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: JHKu1