A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Proscar in Men With Initial Negative Prostate Biopsies - On Going Clinical Trials for Prostate Cancer Drugs

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

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Diagnostic, Treatment

Approved-not yet active

18 and over

Pharmaceutical / Industry

2007_029
MK0906-143, NCT00547079

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
anabolic steroids
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.

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