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

NCT ID: NCT01296672

Last Updated: 2017-10-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

383 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Finasteride

Finasteride 5mg tablets every day by mouth for 3 months

Group Type EXPERIMENTAL

Finasteride

Intervention Type DRUG

Finasteride 5mg every day by mouth for 3 months

Placebo

Placebo 5mg tablet every day by mouth for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo every day by mouth for 3 months

Interventions

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Finasteride

Finasteride 5mg every day by mouth for 3 months

Intervention Type DRUG

Placebo

Placebo every day by mouth for 3 months

Intervention Type DRUG

Other Intervention Names

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Proscar® Propecia®

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Javier Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Hernandez J, Gelfond J, Goros M, Liss MA, Liang Y, Ankerst D, Thompson IM Jr, Leach RJ. The effect of 3-month finasteride challenge on biomarkers for predicting cancer outcome on biopsy: Results of a randomized trial. PLoS One. 2018 Oct 9;13(10):e0204823. doi: 10.1371/journal.pone.0204823. eCollection 2018.

Reference Type DERIVED
PMID: 30300367 (View on PubMed)

Other Identifiers

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R01CA138627

Identifier Type: NIH

Identifier Source: secondary_id

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ROI 10-352H

Identifier Type: -

Identifier Source: org_study_id