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

This study is currently recruiting participants.

Verified January 2013 by The University of Texas Health Science Center at San Antonio

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Ian Thompson, Jr., The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT01296672

First received: February 3, 2011

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

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	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Screening
Official Title:	Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Finasteride

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
Participants will take Finasteride/Placebo 5mg per day by mouth for 3 months before prostate biopsy.

Estimated Enrollment:	500
Study Start Date:	February 2011
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	September 2015 (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

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

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
Patient has been recommended to undergo and plans to have a prostate biopsy.
Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment.
No allergy to finasteride or other five alpha reductase inhibitors.
Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period.
Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.)

Exclusion Criteria:

Risk of cancer greater than 60% or less than 20%.
Prior history of prostate cancer.
Prior treatment with finasteride or dutasteride in the past 6 months
Younger than age 55.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296672

Contacts

Contact: Esther Nanez, RN	210-567-1995	nanez@uthscsa.edu
Contact: Linda Hernandez, RN	210-450-0016	hernandezmh@uthscsa.edu

Locations

United States, Texas
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center	Recruiting
San Antonio, Texas, United States, 78229
Contact: Esther Nanez, RN 210-567-1995 nanez@uthscsa.edu
Contact: Linda Hernandez, RN 210-450-0016 hernandezmh@uthscsa.edu
Principal Investigator: Ian Thompson, MD

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:

Ian Thompson, MD

The University of Texas Health Science Center at San Antonio

More Information

No publications provided

Responsible Party:	Ian Thompson, Jr., Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT01296672 History of Changes
Other Study ID Numbers:	ROI10-352, R01CA138627
Study First Received:	February 3, 2011
Last Updated:	January 23, 2013
Health Authority:	United States: Institutional Review Board

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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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