Login to Access Video or Poster Abstract: MP33-10
Sources of Funding: MDxHealth, Inc.

Introduction

Background: _x000D_ Management of men at risk of prostate cancer (PCa), but with a cancer-negative index biopsy, remains a challenge. PCa diagnosis involves an invasive biopsy procedure that is subject to significant sampling errors, possible negative quality-of-life implications for the patient and high additional costs to the healthcare system. An epigenetic assay assessing PCa-associated DNA-methylation of GSTP1, RASSF1, and APC in histologically negative biopsies has previously been clinically validated to improve the negative predictive value (NPV) relative to standard of care (SOC), yielding a NPV of 90% for all PCa and 96% for high-grade PCa (Gleason Score 7 or higher). Examination of the repeat biopsy rate associated with the outcome of this epigenetic assay would provide further evidence of its clinical utility for improving urologists' management of previously biopsied patients._x000D_ _x000D_ Objective: _x000D_ The primary goal of this study was to determine the rate of repeat biopsy in relation to the epigenetic assay and how this impacted the management of patients.

Methods

Practicing urologists used the epigenetic assay to evaluate 986 men (680 in the case group and 306 in the control group) with a previous negative biopsy. Men in the Case group had an epigenetic assay-negative result and were prospectively followed for a minimum of 12 months from the date of epigenetic profiling. The Control group was managed under SOC.

Results

The two groups were balanced in terms of patient characteristics, except for median age, which was lower in the Case group compared to the Control group (62 vs. 66 years, p<0.001). Use of the epigenetic assay resulted in significantly fewer first repeat biopsies in the Case group compared to the Control group (7.8% vs. 15.4%, respectively; p=0.004). There were also significantly fewer second repeat biopsies in the Case group compared to the Control group (12.1% vs. 26.1%, respectively; p<0.001) and significantly lower PCa detection upon repeat biopsy after a negative epigenetic assay result in the Case group compared to the Control group (0.6% vs. 4.9%, respectively; p<0.001).

Conclusions

In this real-world prospective study, the use of the epigenetic assay resulted in a significant reduction in the rate of excess repeat prostate biopsies.

Funding

MDxHealth, Inc.