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

NCT00600691 | Terminated Phase 2

• 3 other identifiers: H07-01188Health Canada Control #118638Merck Frosst #IISP #P2587
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematuria; Hematospermia

Keywords

Finasteride; hematuria; hematospermia; prostate biopsy

Outcome Measures

Primary Outcomes (1)

• Differences in rate and severity of hematuria and hematospermia among subjects in treatment and placebo groups.

  2 & 4 weeks

Secondary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

5mg finasteride orally, daily for 2 weeks prior to prostate biopsy and one week following prostate biopsy.

Drug: Finasteride

Interventions

Finasteride DRUG

one tablet (5mg) of finasteride

1

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Health Canada: collaborator
• Merck Frosst Canada Ltd.: collaborator

Study Sites (2)

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Location

Victoria General Hospital

Victoria, British Columbia, Canada

Location

MeSH Terms

Conditions

Hematuria; Hemospermia

Interventions

Finasteride

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Peter Pommerville, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

CA (2)