The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Differences in rate and severity of hematuria and hematospermia among subjects in treatment and placebo groups.
研究概览
简要总结
The purpose of our study is primarily to evaluate the effects of 5mg finasteride on hematuria and hematospermia commonly associated with prostate biopsies. We hypothesize that 5mg of finasteride daily for two weeks preceding TRUS prostate biopsy and one week following will reduce hematuria and hematospermia commonly seen as complications following prostate biopsy. We also hypothesize that reducing complications will decrease concern among subjects and make for a more tolerable overall procedure than compared with subjects treated with placebo.
详细描述
Study Purpose:
The purpose of our study is primarily to evaluate the effects of 5mg finasteride on hematuria and hematospermia commonly associated with prostate biopsies. We will also examine how effective the dosing of finasteride administered two weeks prior to biopsy and one week following. We will also use the subject questionnaire to assess subject's attitudes and concerns about hematuria and hematospermia. We will examine the overall subjective tolerability of the biopsy procedure, concerns about sexual function, anxiety surrounding prostate cancer, and urination following the procedure. Questionnaires will use a 10 point visual analog scale to gauge subject's attitudes and concerns. We will examine for any statistically significant correlations between these parameters and the complications we are monitoring. We will also monitor side effects of subjects, in an effort to gauge the potential risks associated with short term usage of finasteride compared to any benefits afforded by finasteride on reducing hematuria and hematospermia.
Hypotheses:
Based on the previous research into the molecular mechanisms of finasteride, we hypothesize that 5mg of finasteride daily for two weeks preceding TRUS prostate biopsy and one week following will reduce hematuria and hematospermia commonly seen as complications following prostate biopsy. We also hypothesize that reducing complications will decrease concern among subjects and make for a more tolerable overall procedure than compared with subjects treated with placebo.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to the participation in any study related activity.
- •Male subject already identified as requiring TRUS prostate biopsy for unrelated medical reasons.
排除标准
- •Suspected or known liver disease.
- •Suspected or known hematological disorders.
- •Subjects who are candidates for immediate surgery.
- •Known hypersensitivity to any component of the product.
研究组 & 干预措施
1
5mg finasteride orally, daily for 2 weeks prior to prostate biopsy and one week following prostate biopsy.
干预措施: Finasteride (Drug)
结局指标
主要结局
Differences in rate and severity of hematuria and hematospermia among subjects in treatment and placebo groups.
时间窗: 2 & 4 weeks
次要结局
- Differences between placebo group and finasteride treatment group in: complication rates, overall subjective experience of biopsy procedure, and concern relating to biopsy. Monitor side effects between placebo and finasteride.(2 & 4 weeks)