Robert L Waterhouse1, Leander Van Neste2, Kelvin A Moses3, Carlton Barnswell4, Jonathan L Silberstein5, Mark Jalkut6, Ronald Tutrone7, James Sylora8, Ronald Anglade9, Myron Murdock10, Zvi Shiffman11, Todd Vandenberg12, Nikhil Shah13, Michael Carter14, Manuel Krispin14, Jack Groskopf14, Wim Van Criekinge15. 1. Consortium on Disparities in Urologic Conditions, Charlotte, NC. 2. Ghent University, Maastricht, Netherlands. 3. Vanderbilt University, Nashville, TN. 4. Advanced Urology Centers of New York, New York, NY. 5. Tulane University, New Orleans, LA. 6. Associated Urologists of North Carolina, Raleigh, NC. 7. Chesapeake Urology, Baltimore, MD. 8. Associated Urological Specialists, Orland Park, IL. 9. Georgia Urology, Duluth, GA. 10. MidAtlantic Urology Associates, Greenbelt, MI. 11. Houston Metro Urology, Houston, TX. 12. Palmetto Urology, Orangeburg, SC. 13. Piedmont Physicians Group, Atlanta, GA. 14. MDxHealth, Irvine, CA. 15. Ghent University, Ghent, Belgium. Electronic address: wim.vancriekinge@gmail.com.
Abstract
OBJECTIVE: To evaluate an epigenetic assay performed on tissue from negative prostate biopsies in a group of African American (AA) men undergoing repeat biopsy, and to compare accuracy for predicting repeat biopsy outcome to prior studies conducted in predominantly Caucasian populations. MATERIALS AND METHODS: The study population consisted of 211 AA men from 7 urology centers across the United States; all of whom were undergoing 12-core transrectal ultrasound-guided repeat biopsy within 30 months from a negative index biopsy. All biopsy cores from the negative index biopsy were profiled for the epigenetic biomarkers GSTP1, APC, and RASSF1 using ConfirmMDx for Prostate Cancer (MDxHealth, Irvine, CA). RESULTS: Upon repeat biopsy, 130 of 211 subjects (62%) had no prostate cancer (PCa) detected and 81 of 211 (38%) were diagnosed with PCa. Of the subjects with PCa, 54 (67%) were diagnosed with Gleason score (GS) ≤6 PCa and 27 (33%) with GS ≥7 disease. For detection of PCa at repeat biopsy, ConfirmMDx sensitivity was 74.1% and specificity was 60.0%, equivalent to prior studies (P = .235 and .697, respectively). For detection of GS ≥7 PCa, sensitivity was 78% and specificity was 53%. The negative predictive values for detection of all PCa and GS ≥7 PCa were 78.8% and 94.2%, respectively. CONCLUSION: In this group of AA men, we successfully validated an epigenetic assay to assess the need for repeat biopsy. Results were consistent with previous studies from predominantly Caucasian populations. Therefore, the ConfirmMDx assay is a useful tool for risk stratification of AA men who had an initial negative biopsy.
OBJECTIVE: To evaluate an epigenetic assay performed on tissue from negative prostate biopsies in a group of African American (AA) men undergoing repeat biopsy, and to compare accuracy for predicting repeat biopsy outcome to prior studies conducted in predominantly Caucasian populations. MATERIALS AND METHODS: The study population consisted of 211 AA men from 7 urology centers across the United States; all of whom were undergoing 12-core transrectal ultrasound-guided repeat biopsy within 30 months from a negative index biopsy. All biopsy cores from the negative index biopsy were profiled for the epigenetic biomarkers GSTP1, APC, and RASSF1 using ConfirmMDx for Prostate Cancer (MDxHealth, Irvine, CA). RESULTS: Upon repeat biopsy, 130 of 211 subjects (62%) had no prostate cancer (PCa) detected and 81 of 211 (38%) were diagnosed with PCa. Of the subjects with PCa, 54 (67%) were diagnosed with Gleason score (GS) ≤6 PCa and 27 (33%) with GS ≥7 disease. For detection of PCa at repeat biopsy, ConfirmMDx sensitivity was 74.1% and specificity was 60.0%, equivalent to prior studies (P = .235 and .697, respectively). For detection of GS ≥7 PCa, sensitivity was 78% and specificity was 53%. The negative predictive values for detection of all PCa and GS ≥7 PCa were 78.8% and 94.2%, respectively. CONCLUSION: In this group of AA men, we successfully validated an epigenetic assay to assess the need for repeat biopsy. Results were consistent with previous studies from predominantly Caucasian populations. Therefore, the ConfirmMDx assay is a useful tool for risk stratification of AA men who had an initial negative biopsy.
Authors: Warwick J Locke; Dominic Guanzon; Chenkai Ma; Yi Jin Liew; Konsta R Duesing; Kim Y C Fung; Jason P Ross Journal: Front Genet Date: 2019-11-14 Impact factor: 4.599
Authors: William G Nelson; Otis W Brawley; William B Isaacs; Elizabeth A Platz; Srinivasan Yegnasubramanian; Karen S Sfanos; Tamara L Lotan; Angelo M De Marzo Journal: J Clin Invest Date: 2022-02-01 Impact factor: 14.808