CAPSTONE PROGRAM1

OAKLAND UNIVERSITY WILLIAM BEAUMONT

oakland.edu/medicine

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Clinical Utility of ConfirmMDx for Prostate Cancer in Management

of Suspected Prostate Cancer

1Thanh Huynh, 2Jason Hafron, MD

1Oakland University William Beaumont School of Medicine2William Beaumont Department of Urology

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What is the clinical utility of the ConfirmMDx Test for Prostate

Cancer, i.e. do the results of the test change frequency of repeat

biopsies, follow-up visits, and prostate-specific antigen tests?

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Introduction

• Prostate cancer is one of the most common cancers in men

• Prostate-specific antigen tests (PSA), digital rectal exams (DRE), and prostate biopsies are methods of screening and detection

• ConfirmMDx (MDxHealth, Inc, Irvine CA) is an epigenetic assay that helps confirm negative biopsy.

• Will ConfirmMDx results decrease future clinical tests?

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Background

• ConfirmMDx for Prostate Cancer is a relatively new test, having come out in May 2012

• Several studies have shown the effectiveness of using epigenetic assays to detect prostate cancer not seen on biopsy1, 2

• One study has shown that ConfirmMDx reduced the rate of repeat prostate biopsies in clinical practice3

• Since ConfirmMDx is a new test, more studies are needed to confirm its clinical utility.

• Want to look at other parameters other than biopsies, such as repeat office visits and PSAs to see if test has clinical utility

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Methods

• Retrospective chart review. • Compare 3 different populations using data collected

from charts of patients at the Michigan Institute of Urology: 1) control group with negative biopsies and no ConfirmMDx test2) negative biopsies with negative ConfirmMDx tests 3) positive biopsies with positive ConfirmMDx tests

• Compare differences between the groups in terms of follow-up visits, biopsies, and PSAs

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MethodsTools/Forms of Analysis

• Use statistical tests to compare treatment in the three groups

• Sample size limited due to the number of patients/charts available to analyze

• Collecting demographic data (age, race, BMI, family history) and clinical data (DRE, PSA, biopsy findings and their dates)

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Challenges/Solutions/Limitations

• Small sample size (~50-100 patients per group) may not be enough data to prove trends in physician behavior

• Using data from one source (Michigan Institute of Urology)

• Limited follow-up times• Ideally, all three groups would be matched

for the main risk factors (e.g. age, race, PSA at biopsy, etc.)

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Results

• Results pending• Hope to find that ConfirmMDx increases

clinical by decreasing the number of follow-up visits, prostate specific antigen tests, and prostate biopsies.

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Concluding Remarks and Discussion

• Most of data has been collected and hoping to perform analysis soon

• ConfirmMDx test could help reduce the number of clinical tests done after biopsy, preventing repeat testing and saving money

• Future work could include larger sample sizes with better matching between groups, and more follow-up time

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• Ayad Khourdaji, MD and Jessica Gibson (MDxHealth)for help with data collection

• MIU Men’s Health Foundation Jeff Murri Scholarship

Acknowledgements

References1. Stewart G, Van Neste L, Delvenne P, et al. Clinical utility of a multiplexed epigenetic gene assay to detect occult cancer in histopathologically negative prostate biopsies: results of the multicenter MATLOC study. J Urol. 2013; 189: 1110-16.

2. Van Neste L, Herman JG, Otto G, et al. The epigenetic promise for prostate cancer diagnosis. Prostate. 2012; 72: 1248-1261.

3. Wojno KJ, Costa FJ, Cornell RJ, et al. Reduced rate of biopsies observed in ConfirmMDx clinical utility field study. Am Health Drug Benefits. 2014; 7(3): 129-134.

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