MP63-15 THE PROFILE FEASIBILITY STUDY: GENETIC PROSTATE CANCER RISK STRATIFICATION FOR TARGETED SCREENING

Abstract

(MSP) assay to validate the results from the European MATLOC study. The cancer prevalence rate of the DOCUMENT cohort was adjusted to 18% to allow direct comparison. The predetermined analytical gene marker cutoffs from MATLOC were used to demonstrate clinical performance. RESULTS: The epigenetic assay resulted in an NPV of 88% (95% confidence interval (CI), 85-91%), a sensitivity of 60% (95% CI, 50-71%) and specificity of 64% (95% CI, 57-70%). Detection of cancerassociated DNA-methylation in the first biopsy was associated with an odds ratio of 2.33 (95% CI, 1.27-4.01; p 1⁄4 0.004) when corrected for other risk factors such as histopathology (p1⁄40.040), age (p1⁄40.046), PSA (p1⁄40.254) and race (p1⁄40.758). CONCLUSIONS: The DOCUMENT study validates this epigenetic assay as a significant, independent predictor for the absence of prostate cancer in a repeat biopsy in this US population. These findings are consistent with and confirm the results from the earlier European MATLOC study, demonstrating an NPV of 90% (95% CI, 86-94%). The consistently high NPV of the epigenetic assay is significantly higher than the use of standard histopathology alone. The addition of this test to other commonly known risk factors can be used to reduce unnecessary repeat prostate biopsies.