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

September 7, 2017 updated by: The University of Texas Health Science Center at San Antonio

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

383

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day
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
Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Javier Hernandez, MD, The University of Texas Health Science Center at San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

February 3, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (ESTIMATE)

February 15, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROI 10-352H
  • R01CA138627 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Finasteride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe