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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00880672
• Collaborator: The Korean Urological Association (Other), GlaxoSmithKline (Industry)
• Enrollment: 40
• Arms: 2
• Duration (Months): 15

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Drug: dutasteride	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. HIF-1a and VEGF expression [2 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Hospital
• The Korean Urological Association
• GlaxoSmithKline

Investigators

• Principal Investigator: Jae-Seung paick, MD, PhD, Dept. of Urology, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ja Hyeon Ku,, Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT00880672
• Other Study ID Numbers: JHKu1
• First Posted: Apr 14, 2009
• Last Update Posted: Jun 12, 2013
• Last Verified: Apr 1, 2009

• Keywords provided by Ja Hyeon Ku,, Associate Professor, Seoul National University Hospital: prostate, dutasteride; vascular endothelial growth factor; hypoxia inducible factor
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Dutasteride

Study Results

No Results Posted as of Jun 12, 2013