摘要
No AccessJournal of UrologyAdult Urology1 Jan 2020Diagnostic Impacts of Clinical Laboratory Based p2PSA Indexes on any Grade, Gleason Grade Group 2 or Greater, or 3 or Greater Prostate Cancer and Prostate Specific Antigen below 10 ng/ml Kazuto Ito, Akira Yokomizo, Shoji Tokunaga, Gaku Arai, Mikio Sugimoto, Koichiro Akakura, Hisashi Hasumi, Hideki Sakai, Akiko Ouraji, Ryo Oki, Eiji Kashiwagi, Yoshitomo Kobori, Hiromi Hirama, Hiroki Kitoh, Hiroji Uemura, Tomoaki Hakariya, and Kazuhiro Suzuki Kazuto ItoKazuto Ito *Correspondence: Institute for Preventive Medicine, Kurosawa Hospital, 187, Yanaka-cho, Takasaki, Gunma 370-1203, Japan telephone: +81-27-352-1166; FAX: +81-27-352-7925; E-mail Address: [email protected] Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Japan Institute for Preventive Medicine, Kurosawa Hospital, Takasaki, Japan Financial interest and/or other relationship with Takeda Pharmaceutical Company, Janssen Pharmaceutical, Astellas Pharma and AstraZeneca. More articles by this author , Akira YokomizoAkira Yokomizo Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan Department of Urology, Hara-Sanshin Hospital, Fukuoka, Japan Financial interest and/or other relationship with Astellas Pharma, AstraZeneca, Bayer Yakuhin, Janssen Pharmaceutical, Sanofi Genzyme and Takeda Pharmaceutical. More articles by this author , Shoji TokunagaShoji Tokunaga Medical Information Center, Kyushu University Hospital, Fukuoka, Japan More articles by this author , Gaku AraiGaku Arai Department of Urology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan More articles by this author , Mikio SugimotoMikio Sugimoto Department of Urology, Kagawa University Faculty of Medicine, Kagawa, Japan More articles by this author , Koichiro AkakuraKoichiro Akakura Japan Community Healthcare Organization Tokyo Shinjuku Medical Center, Tokyo, Japan More articles by this author , Hisashi HasumiHisashi Hasumi Yokohama City University, Yokohama, Japan More articles by this author , Hideki SakaiHideki Sakai Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan Financial interest and/or other relationship with Astellas Pharma, AstraZeneca, Bayer Yakuhin, Janssen Pharmaceutical and Takeda Pharmaceutical. More articles by this author , Akiko OurajiAkiko Ouraji Clinical Research Support Center Kyushu, Fukuoka, Japan More articles by this author , Ryo OkiRyo Oki Institute for Preventive Medicine, Kurosawa Hospital, Takasaki, Japan More articles by this author , Eiji KashiwagiEiji Kashiwagi Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan More articles by this author , Yoshitomo KoboriYoshitomo Kobori Department of Urology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan More articles by this author , Hiromi HiramaHiromi Hirama Department of Urology, Kagawa University Faculty of Medicine, Kagawa, Japan More articles by this author , Hiroki KitohHiroki Kitoh Japan Community Healthcare Organization Tokyo Shinjuku Medical Center, Tokyo, Japan More articles by this author , Hiroji UemuraHiroji Uemura Yokohama City University, Yokohama, Japan More articles by this author , Tomoaki HakariyaTomoaki Hakariya Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan More articles by this author , and Kazuhiro SuzukiKazuhiro Suzuki Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Japan More articles by this author and Members of PROPHET View All Author Informationhttps://doi.org/10.1097/JU.0000000000000495AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: The PROPHET (Prostate Cancer: Prostate Health Index Trial) is a prospective study to clarify the diagnostic impact of laboratory based and prostate volume adjusted p2PSA ([–2] proenzyme prostate specific antigen) related indexes on prostate cancer and clinically significant prostate cancer with prostate specific antigen less than 10 ng/ml. Materials and Methods: Between April 2015 and March 2017, 421 men 50 to 79 years old in the prostate specific antigen range above age specific cutoffs and below 10 ng/ml were registered in the PROPHET. We investigated the diagnostic impacts of various clinical laboratory based free prostate specific antigen related and p2PSA related indexes on any grade and high Gleason grade group prostate cancer. Results: Of the 363 eligible participants 179, 141 and 80 were diagnosed with any grade, and Gleason Grade Group 2-5 and 3-5 prostate cancer, respectively. The AUC-ROCs distinguishing nonprostate cancer vs prostate cancer, nonprostate cancer plus low Gleason Grade Group and low volume vs remaining prostate cancer with a higher Gleason Grade group or a higher volume on the PHI (Prostate Health Index) were significantly superior to the AUC-ROCs of prostate specific antigen and free-to-total prostate specific antigen. At 90% sensitivity in all investigated p2PSA related indexes the false-positive rate was superior to that of prostate specific antigen and free-to-total prostate specific antigen in any group comparison in terms of the Gleason Grade Group and positive biopsy cores. In 35% to 42% of men without prostate cancer and/or those with less aggressive prostate cancer the PHI would avoid unnecessary biopsy. Conclusions: Laboratory based p2PSA related indexes were significantly superior for detecting clinically significant prostate cancer compared to free-to-total prostate specific antigen. The indexes those would avoid up to 42% of prostate biopsies in men without aggressive cancer while maintaining 90% sensitivity. References 1. : Prostate cancer in Asian men. Nat Rev Urol 2014; 11: 197. Google Scholar 2. : Long-term longitudinal changes in baseline PSA distribution and estimated prevalence of prostate cancer in male Japanese participants of population-based PSA screening. 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Link, Google Scholar The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number. Supported by the Clinical Research Support Center Kyushu, Fukuoka, Japan. No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue 1January 2020Page: 83-91Supplementary Materials Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.Keywordshematologic testsprostate-specific antigenmass screeningenzyme precursorsprostatic neoplasmsMetricsAuthor Information Kazuto Ito Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Japan Institute for Preventive Medicine, Kurosawa Hospital, Takasaki, Japan *Correspondence: Institute for Preventive Medicine, Kurosawa Hospital, 187, Yanaka-cho, Takasaki, Gunma 370-1203, Japan telephone: +81-27-352-1166; FAX: +81-27-352-7925; E-mail Address: [email protected] Financial interest and/or other relationship with Takeda Pharmaceutical Company, Janssen Pharmaceutical, Astellas Pharma and AstraZeneca. More articles by this author Akira Yokomizo Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan Department of Urology, Hara-Sanshin Hospital, Fukuoka, Japan Financial interest and/or other relationship with Astellas Pharma, AstraZeneca, Bayer Yakuhin, Janssen Pharmaceutical, Sanofi Genzyme and Takeda Pharmaceutical. More articles by this author Shoji Tokunaga Medical Information Center, Kyushu University Hospital, Fukuoka, Japan More articles by this author Gaku Arai Department of Urology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan More articles by this author Mikio Sugimoto Department of Urology, Kagawa University Faculty of Medicine, Kagawa, Japan More articles by this author Koichiro Akakura Japan Community Healthcare Organization Tokyo Shinjuku Medical Center, Tokyo, Japan More articles by this author Hisashi Hasumi Yokohama City University, Yokohama, Japan More articles by this author Hideki Sakai Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan Financial interest and/or other relationship with Astellas Pharma, AstraZeneca, Bayer Yakuhin, Janssen Pharmaceutical and Takeda Pharmaceutical. More articles by this author Akiko Ouraji Clinical Research Support Center Kyushu, Fukuoka, Japan More articles by this author Ryo Oki Institute for Preventive Medicine, Kurosawa Hospital, Takasaki, Japan More articles by this author Eiji Kashiwagi Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan More articles by this author Yoshitomo Kobori Department of Urology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan More articles by this author Hiromi Hirama Department of Urology, Kagawa University Faculty of Medicine, Kagawa, Japan More articles by this author Hiroki Kitoh Japan Community Healthcare Organization Tokyo Shinjuku Medical Center, Tokyo, Japan More articles by this author Hiroji Uemura Yokohama City University, Yokohama, Japan More articles by this author Tomoaki Hakariya Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan More articles by this author Kazuhiro Suzuki Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Japan More articles by this author Expand All The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number. Supported by the Clinical Research Support Center Kyushu, Fukuoka, Japan. No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Advertisement PDF downloadLoading ...