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Sponsors and Collaborators: |
University Health Network, Toronto Merck Frosst Canada Ltd. |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00542243 |
The purpose of this study is to assess whether six months of daily finasteride (PROSCAR), following an initial negative prostate biopsy, will improve the detection of prostate cancer on repeat biopsy.
144 subjects with an initial negative prostate biopsy will be randomized to receive either finasteride or placebo for 6 months. The subjects will undergo a second prostate biopsy following drug intervention. PSA (prostate specific antigen) measurements, testosterone levels, and quality of life questionnaires will also be assessed during the study. The two groups will then be compared.
Condition | Intervention | Phase |
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Enlarged Prostate |
Drug: Finasteride Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of PROSCAR in Men With Initial Negative Prostate Biopsies |
Estimated Enrollment: | 144 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Finasteride
Finasteride (5mg) will be given once per day for 6 months.
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2: Placebo Comparator |
Drug: Placebo
Placebo will be given once a day for 6 months.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Keri L Durrant, BSc. | 416-946-4501 ext 3431 | keri.durrant@uhn.on.ca |
Contact: Hersey Karen, RN | 416-946-2155 | karen.hersey@uhn.on.ca |
Canada, Ontario | |
University Health Network, Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 |
Principal Investigator: | Antonio Finelli, MD MSc FRCSC | University Health Network, Toronto |
Responsible Party: | University Health Network ( Dr. Antonio Finelli/Urologic Oncologist ) |
Study ID Numbers: | 07-0499-B |
Study First Received: | October 9, 2007 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00542243 |
Health Authority: | Canada: Health Canada |
enlarged prostate finasteride |
Finasteride |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions |