Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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