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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: September 8, 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:

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:

Pre/Post Ratio PSA Area Under the Curve (AUC) [ Time Frame: 90-day: 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: Baseline, 30 days, 60 days and 90-day ]
Accuracy of prediction area under the curve (AUC) receiver operating characteristics (sensitivity and specificity) of the 3 month finasteride PSA velocity and to have adequate power to detect the 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: Baseline, 30 days, 60 days, and 90 days ]
Accuracy of prediction area under the receiver operating characteristics curve (AUC) to assess the prediction of risk of prostate cancer based on the change from baseline to 90 days for subjects taking finasteride, compared to subjects taking placebo who received biopsy.


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:

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

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:	September 8, 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

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