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