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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Javier Hernandez, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01296672
First received: February 3, 2011
Last updated: April 22, 2016
Last verified: April 2016

February 3, 2011
April 22, 2016
February 2011
March 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Participants will take Finasteride/Placebo 5mg per day by mouth for 3 months before prostate biopsy.
Determine if finasteride improves the performance of Prostate Specific Antigen (PSA) and Digital Rectal Exam (DRE) for prostate cancer screening. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Participants will take Finasteride/Placebo 5mg per day by mouth for 3 months before prostate biopsy.
Complete list of historical versions of study NCT01296672 on ClinicalTrials.gov Archive Site
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3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Screening
Prostate Cancer
  • Drug: Finasteride
    Finasteride 5mg every day by mouth for 3 months
    Other Names:
    • Proscar®
    • Propecia®
  • Drug: Placebo
    Placebo every day by mouth for 3 months
  • Experimental: Finasteride
    Finasteride 5mg tablets every day by mouth for 3 months
    Intervention: Drug: Finasteride
  • Placebo Comparator: Placebo
    Placebo 5mg tablet every day by mouth for 3 months
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
385
Not Provided
March 2016   (final data collection date for primary outcome measure)

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.
Male
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01296672
ROI10-352, R01CA138627
No
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Javier Hernandez, The University of Texas Health Science Center at San Antonio
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
The University of Texas Health Science Center at San Antonio
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP