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

Study Overview
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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.

Official Title
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Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Finasteride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Finasteride<br>Finasteride 5mg tablets every day by mouth for 3 months | Drug: Finasteride<br>* Finasteride 5mg every day by mouth for 3 months<br>* Other names: Propecia®;|
| Placebo Comparator: Placebo<br>Placebo 5mg tablet every day by mouth for 3 months | Drug: Placebo<br>* Placebo every day by mouth for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre/Post Ratio PSA Area Under the Curve (AUC) | 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. | Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCA3 (Prostate Cancer Antigen 3)Score AUC | 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) | Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day | 
| T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC | 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 | Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Finasteride, Placebo, Prostate cancer, Prostate Specific Antigen (PSA), Men at intermediate risk of prostate cancer, Men scheduled for prostate biopsy