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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Finasteride; Drug: Placebo	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	383 participants
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
Study Start Date :	February 2011
Actual Primary Completion Date :	November 2016
Actual Study Completion Date :	January 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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)
2. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	55 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted:	February 15, 2011
Results First Posted:	September 8, 2017
Last Update Posted:	October 6, 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