3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer

The primary goal of this proposal is to determine if a 5-alpha reductase 'challenge' improves
screening performance of PSA and DRE in men who are scheduled for prostate biopsy. Currently
a higher PSA level leads to a recommendation for prostate biopsy, causing hundreds of
thousands of unnecessary biopsies annually in the U.S. We will show that a three-month
treatment with finasteride for men with high PSA levels will better predict the man who
should have a prostate biopsy. PSA performance after finasteride 'challenge' will also be
compared with new tests for prostate cancer. Finasteride is supplied by Merck and Company,
Incorporated.

Inclusion Criteria:

1. Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention
Trial (PCPT) prostate cancer risk calculator.
(www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months
prior to study entry. A description of the frequency of these individuals in the
population is provided in Specific Aim 2

2. Patient has been recommended to undergo and plans to have a prostate biopsy.

3. Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo
treatment.

4. No allergy to finasteride or other five alpha reductase inhibitors.

5. Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month
treatment period.

6. Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for
this age range.)

Exclusion Criteria:

1. Risk of cancer greater than 60% or less than 20%.

2. Prior history of prostate cancer.

3. Prior treatment with finasteride or dutasteride in the past 6 months

4. Younger than age 55.