Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- HIF-1a and VEGF expression
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
dutasteride
oral, 5mg, once per day, 2 weeks
干预措施: dutasteride (Drug)
结局指标
主要结局
HIF-1a and VEGF expression
时间窗: 2 weeks
effects of dutasteride on the expression of angiogenesis markers in rat and human prostates
次要结局
未报告次要终点
研究者
Ja Hyeon Ku,
Associate Professor
Seoul National University Hospital