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A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Proscar in Men With Initial Negative Prostate Biopsies
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase IV
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Diagnostic, Treatment
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Approved-not yet active
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18 and over
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Pharmaceutical / Industry
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2007_029 MK0906-143, NCT00547079
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Trial Description
Summary Twenty percent of men with an initial negative prostate biopsy are found to have cancer on a repeat biopsy. finasteride (a 5-ARI) reduces prostate volume and improves the utility of PSA and DRE. thus, six months of finasteride may improve the detection rate of prostate cancer in men with an initial negative biopsy. Eligibility Criteria Inclusion Criteria: - Initial biopsy, performed at UHN, of at least 8 cores with no evidence of cancer (HGPIN or ASAP followed)
- PSA less or equal to 20ng/ml
- Prostate volume greater or equal to 25cc and less or equal to 81cc
- Able to swallow and retain oral medication
- Able to read and write (IPSS questionnaire is self-administered), understand instructions related to study procedures and to give written informed consent
Exclusion Criteria: - Glucocorticosteroids, except inhaled or topical, are not permitted within 3 months prior to visit 1
- concurrent and previous use within the past 12 months of the following medications:
- finasteride (proscar, propecia)
- dutasteride (gi198745, avodart)
- any other investigational 5a-reductase inhibitors
- drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents)
- Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period
- Abnormal liver function test (greater than 2 times the upper limit of normal for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP); or bilirubin greater than 1.5 times the upper limit of normal
- Serum creatinine greater than 1.5 times the upper limit of normal
- Any unstable serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management
- History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject
- Known hypersensitivity to any 5a-reductase inhibitor or to any drug chemically related to proscar
Trial Contact Information
Trial Lead Organizations/Sponsors Merck and Company, Incorporated Medical Monitor | | Study Director |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00547079 Information obtained from ClinicalTrials.gov on February 19, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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