94 Background: There is an unmet need for methods to better identify patients most likely to benefit from repeat prostate biopsy after an initial negative biopsy. ConfirmMDx is a molecular test clinically validated for detection of prostate cancer (PCa) in tissue from PCa-negative biopsies. In this clinical utility study, we evaluated the impact of ConfirmMDx on the management of patients being considered for repeat prostate biopsy in a community urology practice. Methods: The study population consisted of 605 men with a prior PCa-negative prostate biopsy, who were counseled on the need to undergo repeat biopsy at a large community urology practice due to persistent elevated risk of PCa. All tissue cores from each PCa-negative patient were tested with the ConfirmMDx methylation-specific PCR test, and positive or negative ConfirmMDx results based on the presence or absence of GSTP1, APC or RASSF1 methylation in the biopsy tissue. ConfirmMDx results were provided to the physician for use in repeat biopsy decision-making. Medical record review was conducted at a minimum of nine months after ConfirmMDx results were reported. Results: Of the 605 subjects enrolled, 308 (51%) had a negative ConfirmMDx test result and 297 (49%) were positive. For the entire study population, average age was 64 (median 64, interquartile range 59 to 69), average serum PSA level 6.8 ng/mL (5.7, 4.3 to 8.1). The median follow-up for both Confirm positives and negatives was 10 months post-testing. Repeat biopsy rates for ConfirmMDx positive and negative men were 32.3% (96/297) and 5.8% (15/308), respectively (P < 0.001). For patients who received a biopsy during the follow-up period, the time between ConfirmMDx and repeat biopsy was shorter for ConfirmMDx positive men versus ConfirmMDx negatives (median 4 vs. 8 months, P = 0.007). Conclusions: In this utility study, ConfirmMDx had a significant impact on repeat prostate biopsy decision-making in a U.S. community urology setting. Repeat biopsy rates in ConfirmMDx positive men were six-fold higher than in ConfirmMDx negatives. These results reflect the clinical utility of ConfirmMDx for biopsy decision-making in real world clinical practice.

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INTRODUCTION AND OBJECTIVES: DNA promoter hypermethylation (Confirm MDX) may pick up occult prostate cancer due to a field defect the tumor exerts on normal tissue. The reported negative predictive value of Confirm MDX is high, ranging from 90-96% for low and high-grade cancer, respectively. In this study, we obtained MRI on all patients with a negative Confirm MDX to correlate imaging findings. We asked whether MRI can safely be omitted in the setting of a negative Confirm MDX.METHODS: All patients with elevated PSA and negative systematic prostate needle biopsy within 24 months of referral prospectively underwent Confirm MDX tissue testing (MDX) and 1.5 Tesla multiparametric MRI (no endorectal coil). MRI was centrally re-reviewed and PIRADS v.2 score was assigned to suspicious regions of interest (ROI). PIRADS 3 or higher lesions were considered abnormal. Clinicopathologic and imaging characteristics were analyzed.RESULTS: 113 patients underwent MDX and MRI. MDX was negative (MDX-) in 56 patients (49.6%). Among MDX-, MRI was negative (MRI-) in 40 (71.4%). Of the MRIþ patients, PIRADS 3-5 lesions were detected at a frequency of 56.25%, 31.25%, and 12.5%, respectively. Variables that correlated with a negative MRI included low PSA (7.82 ng/dL vs 11.2 ng/dL, p [0.033), lower PSA density ([PSAD] 0.13 ng/dL/mL vs. 0.21 ng/dL/mL, p[0.12), and smaller prostate volume (67.8 mL vs. 98.2 mL, p[0.028). Prostate volume among PIRADS 3, 4, and 5 lesions was 88.5 mL, 133.5 mL, and 30.6 mL, respectively. ROI diameter in each group measured 10.9 mm, 12.5 mm, and 24 mm. PIRADS 3, 4, and 5 lesions were identified in the transition zone in 75%, 0%, and 0% of cases. Of note, both PIRADS 5 lesions were located in the anterior base of the prostate; the MDX tissue samples in both patients only included the anterior apex.CONCLUSIONS: The majority of Confirm MDX negative patients also had a negative mpMRI at 1.5T. Of patients with an abnormal MRI, most were PIRADS 3 transition zone lesions in large glands which historically rarely harbor prostate cancer. PSA < 10 and smaller gland size were significant predictors of negative MRI in the negative MDX patients. Anterior prostate cancers may be detected less often by Confirm MDX due to inadequate anterior prostate sampling at biopsy.

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