Trial | NCT00880672  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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).
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 Started
Jan 31
2008
Primary Completion
Dec 31
2008
Study Completion
Apr 30
2009
Last Update
Jun 12
2013
Estimate

Drug dutasteride

5mg, oral, daily, 2-4 weeks

dutasteride Active Comparator

oral, 5mg, once per day, 2 weeks

placebo Placebo Comparator

oral, 5mg, once per day, 2 weeks

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
No Results Posted