Clinical Trial: The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy

Brief Summary: 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.

Detailed Summary:

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:

To determine the effectiveness of 5mg finasteride administered two weeks prior to prostate biopsy and one week following on reducing hematuria and hematos
Sponsor: University of British Columbia

Current Primary Outcome: Differences in rate and severity of hematuria and hematospermia among subjects in treatment and placebo groups. [ Time Frame: 2 & 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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. [ Time Frame: 2 & 4 weeks ]

Original Secondary Outcome: Same as current

Information By: University of British Columbia

Dates:
Date Received: January 14, 2008
Date Started: March 2008
Date Completion:
Last Updated: January 29, 2014
Last Verified: January 2014