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Main Objective
To see whether the drug finasteride (Proscar™) can prevent prostate cancer in men age 55 and older.
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Enrollment Period
October 1993 - May 1997
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Participants
18,882 men: 92 percent white, 4 percent African American, 4 percent other races/ethnicities
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Intervention
Men were randomly assigned to take either 5 milligrams of finasteride or a placebo (dummy pill) once daily for seven years. All men had an annual digital rectal exam and prostate-specific antigen (PSA) test. At the end of the seven years, men who had not been diagnosed with prostate cancer were asked to have a prostate biopsy to see if they were truly cancer free.
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Criteria for Participation
- Men, age 55 and older
- General good health
- No evidence of prostate cancer at beginning of trial
- Prostate Specific Antigen (PSA) 3 ng/ml
- Willing to have a prostate biopsy at the end of the study
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Study Sites
222 centers, located in the United States and Canada
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Additional Study Objectives
- To determine if finasteride affects the stage and grade of prostate cancers
- To see if finasteride affects the number of deaths from prostate cancer and the number of deaths from all cancers
- To see if finasteride changes the occurrence and type of noncancerous prostate growth
- To estimate the accuracy of digital rectal exam and PSA testing -- separately and together -- in detecting whether a man has prostate cancer
- To measure how long-term treatment with finasteride affects a man's urinary and sexual function
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