Mp17-07 validation of micheck prostate for significant prostate cancer in an australian population

You have accessJournal of UrologyCME1 Apr 2023MP17-07 VALIDATION OF MICHECK PROSTATE FOR SIGNIFICANT PROSTATE CANCER IN AN AUSTRALIAN POPULATION David Gillatt, Dmitry Polikarpov, Ian Smith, Howard Lau, Lawrence Kim, Chi Can Huynh, Kheng Sit Lim, Jaya Siddireddy, Yanling Lu, Ninantao Deng, Douglas Campbell, Brad Walsh, and Manish Patel David GillattDavid Gillatt More articles by this author , Dmitry PolikarpovDmitry Polikarpov More articles by this author , Ian SmithIan Smith More articles by this author , Howard LauHoward Lau More articles by this author , Lawrence KimLawrence Kim More articles by this author , Chi Can HuynhChi Can Huynh More articles by this author , Kheng Sit LimKheng Sit Lim More articles by this author , Jaya SiddireddyJaya Siddireddy More articles by this author , Yanling LuYanling Lu More articles by this author , Ninantao DengNinantao Deng More articles by this author , Douglas CampbellDouglas Campbell More articles by this author , Brad WalshBrad Walsh More articles by this author , and Manish PatelManish Patel More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003237.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: PSA screening and multi parametric MRI are widely used to identify patients with suspected prostate cancer who may benefit from prostate biopsy. Patients with PIRADs scores 3-5 are typically biopsied, however up to 17% of patients with PIRADs scores of 1-2 will harbour clinically significant cancers that would remain undiagnosed using these criteria, while up to 80% of PIRADs 3 patients do not have clinically significant cancers. Hence there is a requirement for additional tests better able to guide prostate biopsy decisions. MiCheck Prostate is a serum-based test for aggressive prostate cancer (GS3+4 or higher) developed by Minomic International that uses a proprietary algorithm to combine results from three standard blood markers with clinical factors to provide a risk score for clinically significant cancer. The current study was designed to assess the test performance of MiCheck Prostate in an Australian study cohort. METHODS: The study was conducted at Macquarie University Hospital (MUH, Ethics approval 5201500707). Serum samples were collected from patients undergoing prostate biopsies. Blood markers were measured at Douglass Hanley Moir (DHM) laboratories using Abbott Architect and Alinity immunoassays. RESULTS: 192 patient samples were collected: 78 (41%) had no cancer, 37 (19%) had insignificant cancer (Gleason 3+3) and 77 (40%) had Gleason 3+4 or higher. 2 (1%) patients had PIRADs 1, 16 (8%) had PIRADS 2, 23 (12%) PIRADs 3, 88 (46%) had PIRADs 4 and 55 (29%) had PIRADs 5 and 8 (4%) patients had no PIRADs data. When used prior to MRI, MiCheck Prostate had 92% sensitivity for detection of clinically significant cancers. The AUC for MiCheck Prostate was significantly higher than PSA (0.71 vs 0.58, p=0.03). When used post MRI, MiCheck Prostate showed sensitivity of 94% and specificity of 39% for detection of significant prostate cancer in the overall patient population. The AUC for MiCheck Prostate was significantly higher than PSA (0.79 vs 0.58, p<0.0001). In 49 patients with PIRADs score of 3 or lower, MiCheck Prostate showed sensitivity of 92% and specificity of 65%, with NPV of 96%. CONCLUSIONS: The current study demonstrates MiCheck Prostate has high sensitivity for detection of significant prostate cancer in an Australian population. MiCheck Prostate has high sensitivity in both the pre-MRI and post-MRI settings as well as in the PIRADs 1-3 subgroup. MiCheck Prostate provides additional information to urologists and patients in the decision to proceed to prostate biopsy with patients suspected of having prostate cancer. Source of Funding: Minomic International Ltd, Australian Government SIEF © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e215 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information David Gillatt More articles by this author Dmitry Polikarpov More articles by this author Ian Smith More articles by this author Howard Lau More articles by this author Lawrence Kim More articles by this author Chi Can Huynh More articles by this author Kheng Sit Lim More articles by this author Jaya Siddireddy More articles by this author Yanling Lu More articles by this author Ninantao Deng More articles by this author Douglas Campbell More articles by this author Brad Walsh More articles by this author Manish Patel More articles by this author Expand All Advertisement PDF downloadLoading ...