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

Overview

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.

Full Title of Study: “Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2016

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.

Interventions

  • Drug: Finasteride
    • Finasteride 5mg every day by mouth for 3 months
  • Drug: Placebo
    • Placebo every day by mouth for 3 months

Arms, Groups and Cohorts

  • Experimental: Finasteride
    • Finasteride 5mg tablets every day by mouth for 3 months
  • Placebo Comparator: Placebo
    • Placebo 5mg tablet every day by mouth for 3 months

Clinical Trial Outcome Measures

Primary Measures

  • Pre/Post Ratio PSA Area Under the Curve (AUC)
    • Time Frame: Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months
    • Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.

Secondary Measures

  • PCA3 (Prostate Cancer Antigen 3)Score AUC
    • Time Frame: Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day
    • Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)
  • T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC
    • Time Frame: Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days
    • Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center at San Antonio
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Javier Hernandez, MD, Principal Investigator, The University of Texas Health Science Center at San Antonio

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