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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01296672
First Posted: February 15, 2011
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
  Purpose
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: Triple (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:
  • 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 Outcome 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


Enrollment: 383
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296672


Locations
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)
Investigators
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
ClinicalTrials.gov Identifier: NCT01296672     History of Changes
Other Study ID Numbers: ROI 10-352H
R01CA138627 ( U.S. NIH Grant/Contract )
First Submitted: February 3, 2011
First Posted: February 15, 2011
Results First Submitted: June 26, 2017
Results First Posted: September 8, 2017
Last Update Posted: October 6, 2017
Last Verified: March 2017

Keywords provided by The University of Texas Health Science Center at San Antonio:
Finasteride
Placebo
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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Finasteride
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