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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

The investigators will propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Finasteride

Criteria

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.