The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy - Full Text View

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 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.

Condition	Intervention	Phase
Hematuria Hematospermia	Drug: Finasteride	Phase II

ChemIDplus related topics:

Finasteride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Differences in rate and severity of hematuria and hematospermia among subjects in treatment and placebo groups. [ Time Frame: 2 & 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 5mg finasteride orally, daily for 2 weeks prior to prostate biopsy and one week following prostate biopsy.	Drug: Finasteride one tablet (5mg) of finasteride

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Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600691

Contacts


Contact: Nathan Hoag	250-216-4455	natman@interchange.ubc.ca

Locations


Canada, British Columbia
	Royal Jubilee Hospital	Recruiting
	Victoria, British Columbia, Canada
	Contact: Nathan Hoag 250-216-4455 natman@interchange.ubc.ca
	Victoria General Hospital	Recruiting
	Victoria, British Columbia, Canada
	Contact: Nathan Hoag 250-216-4455 natman@interchange.ubc.ca

Sponsors and Collaborators

University of British Columbia

Health, Canada

Merck Frosst Canada Ltd.

Investigators


Principal Investigator:	Peter Pommerville, MD	University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Dr. Peter Pommerville )
Study ID Numbers:	H07-01188, Health Canada Control #118638, Merck Frosst #IISP #P2587
First Received:	January 14, 2008
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00600691
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Finasteride

hematuria

hematospermia

prostate biopsy

Study placed in the following topic categories:

Finasteride

Urologic Diseases

Hematuria

Urination Disorders

Genital Diseases, Male

Hemorrhage

Hemospermia

Additional relevant MeSH terms:

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	University of British Columbia Health, Canada Merck Frosst Canada Ltd.
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00600691