Waterhouse Robert L, Van Neste Leander, Moses Kelvin A, Barnswell Carlton, Silberstein Jonathan L, Jalkut Mark, Tutrone Ronald, Sylora James, Anglade Ronald, Murdock Myron, Shiffman Zvi, Vandenberg Todd, Shah Nikhil, Carter Michael, Krispin Manuel, Groskopf Jack, Van Criekinge Wim
Consortium on Disparities in Urologic Conditions, Charlotte, NC.
Ghent University, Maastricht, Netherlands.
Urology. 2019 Jun;128:62-65. doi: 10.1016/j.urology.2018.04.001. Epub 2018 Apr 13.
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.
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).
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.
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.
评估对一组接受重复活检的非裔美国（AA）男性患者阴性前列腺活检组织进行的表观遗传学检测，并将预测重复活检结果的准确性与之前在以白种人为主的人群中开展的研究进行比较。
研究人群包括来自美国7家泌尿外科中心的211名AA男性；他们均在初次活检为阴性后的30个月内接受12针经直肠超声引导下的重复活检。使用前列腺癌的ConfirmMDx（MDxHealth，加利福尼亚州欧文市）对初次阴性活检的所有活检针进行表观遗传生物标志物GSTP1、APC和RASSF1分析。
重复活检时，211名受试者中有130名（62%）未检测到前列腺癌（PCa），211名中有81名（38%）被诊断为PCa。在患有PCa的受试者中，54名（67%）被诊断为Gleason评分（GS）≤6的PCa，27名（33%）被诊断为GS≥7疾病。对于重复活检时PCa的检测，ConfirmMDx的敏感性为74.1%，特异性为60.0%，与之前的研究相当（P分别为0.235和0.697）。对于GS≥7的PCa检测，敏感性为78%，特异性为53%。检测所有PCa和GS≥7的PCa的阴性预测值分别为78.8%和94.2%。
在这组AA男性中，我们成功验证了一种表观遗传学检测方法以评估重复活检的必要性。结果与之前以白种人为主的人群的研究一致。因此，ConfirmMDx检测对于初次活检为阴性的AA男性进行风险分层是一种有用的工具。
