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

This study has been completed.

Sponsor:

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

ClinicalTrials.gov Identifier:

NCT01296672

First received: February 3, 2011

Last updated: March 14, 2017

Last verified: March 2017

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 Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator Primary Purpose: Screening
Official Title:	Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

Resource links provided by NLM:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: 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 ]
Participants will take Finasteride/Placebo 5mg per day by mouth for 3 months before prostate biopsy.


Enrollment:	385
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


Ages Eligible for Study:	55 Years and older (Adult, Senior)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:	ROI10-352 R01CA138627 ( US NIH Grant/Contract Award Number )
Study First Received:	February 3, 2011
Last Updated:	March 14, 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

ClinicalTrials.gov processed this record on June 21, 2017

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