This trial is active, not recruiting.

Condition prostate cancer
Treatments finasteride, placebo
Phase phase 4
Sponsor The University of Texas Health Science Center at San Antonio
Collaborator National Institutes of Health (NIH)
Start date February 2011
End date March 2016
Trial size 385 participants
Trial identifier NCT01296672, R01CA138627, ROI10-352


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose screening
Finasteride 5mg tablets every day by mouth for 3 months
finasteride Proscar®
Finasteride 5mg every day by mouth for 3 months
(Placebo Comparator)
Placebo 5mg tablet every day by mouth for 3 months
Placebo every day by mouth for 3 months

Primary Outcomes

Determine if finasteride improves the Prostate Specific Antigen (PSA) and the Digital Rectal Exam (DRE) for prostate cancer screening by reducing the PSA and the size of the prostate.
time frame: 3 months

Eligibility Criteria

Male participants at least 55 years old.

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.

Additional Information

Official title Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test
Principal investigator Javier Hernandez, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio.
Location data was received from the National Cancer Institute and was last updated in May 2016.