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

This study is currently recruiting participants.

Verified September 2011 by University of British Columbia

First Received on January 14, 2008. Last Updated on September 19, 2011 History of Changes

Sponsor:	University of British Columbia
Collaborators:	Health Canada Merck Frosst Canada Ltd.
Information provided by (Responsible Party):	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00600691

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy

Resource links provided by NLM:

Drug Information available for: Finasteride

U.S. FDA Resources

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:	December 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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

No publications provided

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00600691 History of Changes
Other Study ID Numbers:	H07-01188, Health Canada Control #118638, Merck Frosst #IISP #P2587
Study First Received:	January 14, 2008
Last Updated:	September 19, 2011
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Finasteride
hematuria
hematospermia
prostate biopsy

Additional relevant MeSH terms:

Hematuria
Hemospermia
Urination Disorders
Urologic Diseases
Hemorrhage
Pathologic Processes

Genital Diseases, Male
Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012