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

This study has been completed.
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio Identifier:
First received: February 3, 2011
Last updated: March 14, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Prostate Cancer
Drug: Finasteride
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Screening
Official Title: Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

Resource links provided by NLM:

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • 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 ]
    Participants will take Finasteride/Placebo 5mg per day by mouth for 3 months before prostate biopsy.

Enrollment: 385
Study Start Date: February 2011
Study Completion Date: January 2017
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Finasteride
Finasteride 5mg tablets every day by mouth for 3 months
Drug: Finasteride
Finasteride 5mg every day by mouth for 3 months
Other Names:
  • Proscar®
  • Propecia®
Placebo Comparator: Placebo
Placebo 5mg tablet every day by mouth for 3 months
Drug: Placebo
Placebo every day by mouth for 3 months

Detailed 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.

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention Trial (PCPT) prostate cancer risk calculator. ( 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01296672

United States, Texas
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Principal Investigator: Javier Hernandez, MD The University of Texas Health Science Center at San Antonio
  More Information

Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT01296672     History of Changes
Other Study ID Numbers: ROI10-352
R01CA138627 ( US NIH Grant/Contract Award Number )
Study First Received: February 3, 2011
Last Updated: March 14, 2017

Keywords provided by The University of Texas Health Science Center at San Antonio:
Prostate cancer
Prostate Specific Antigen (PSA)
Men at intermediate risk of prostate cancer
Men scheduled for prostate biopsy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents processed this record on May 25, 2017