title: Performance of the Prostate Health Index in predicting prostate biopsy outcomes among men with a negative digital rectal examination and transrectal ultrasonography.
abstract: The [-2]proPSA (p2PSA) and its derivatives, the p2PSA-to-free PSA ratio (%p2PSA), and the Prostate Health Index (PHI) have greatly improved discrimination between men with and without prostate cancer (PCa) in prostate biopsies. However, little is known about their performance in cases where a digital rectal examination (DRE) and transrectal ultrasonography (TRUS) are negative. A prospective cohort of 261 consecutive patients in China with negative DRE and TRUS were recruited and underwent prostate biopsies. A serum sample had collected before the biopsy was used to measure various PSA derivatives, including total prostate-specific antigen (tPSA), free PSA, and p2PSA. For each patient, the free-to-total PSA ratio (%fPSA), PSA density (PSAD), p2PSA-to-free PSA ratio (%p2PSA), and PHI were calculated. Discriminative performance was assessed using the area under the receiver operating characteristic curve (AUC) and the biopsy rate at 91% sensitivity. The AUC scores within the entire cohort with respect to age, tPSA, %fPSA, PSAD, p2PSA, %p2PSA, and PHI were 0.598, 0.751, 0.646, 0.789, 0.814, 0.808, and 0.853, respectively. PHI was the best predictor of prostate biopsy results, especially in patients with a tPSA of 10.1-20 ng ml-1 . Compared with other markers, at a sensitivity of 91%, PHI was the most useful for determining which men did not need to undergo biopsy, thereby avoiding unnecessary procedures. The use of PHI could improve the accuracy of PCa detection by predicting prostate biopsy outcomes among men with a negative DRE and TRUS in China.
authors.affiliation: Fudan Institute of Urology, Huashan Hospital, Fudan University, Shanghai; Department of Urology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Guo-Peng
authors.initials: GP
authors.lastname: Yu
authors.affiliation: Fudan Institute of Urology, Huashan Hospital, Fudan University, Shanghai; Department of Urology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Rong
authors.initials: R
authors.lastname: Na
authors.affiliation: Department of Urology, Fudan University Shanghai Cancer Center and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
authors.forename: Ding-Wei
authors.initials: DW
authors.lastname: Ye
authors.affiliation: Department of Urology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Qi
authors.affiliation: Fudan Institute of Urology, Huashan Hospital, Fudan University, Shanghai, China; State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai, China; Center for Cancer Genomics, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA, .
authors.forename: Fang
authors.initials: F
authors.lastname: Liu
authors.affiliation: State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai, China.
authors.forename: Hai-Tao
authors.initials: HT
authors.lastname: Chen
authors.affiliation: Fudan Institute of Urology, Huashan Hospital, Fudan University, Shanghai; Department of Urology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Yi-Shuo
authors.initials: YS
authors.lastname: Wu
authors.affiliation: Department of Urology, Fudan University Shanghai Cancer Center and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
authors.forename: Gui-Ming
authors.initials: GM
authors.lastname: Zhang
authors.affiliation: Center for Cancer Genomics, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
authors.forename: Jie-Lin
authors.initials: JL
authors.lastname: Sun
authors.affiliation: Department of Urology, Fudan University Shanghai Cancer Center and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
authors.forename: Yao
authors.initials: Y
authors.lastname: Zhu
authors.affiliation: Department of Urology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
authors.forename: Li-Qun
authors.initials: LQ
authors.lastname: Huang
authors.affiliation: Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Shan-Cheng
authors.initials: SC
authors.lastname: Ren
authors.affiliation: State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai, China; Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, IL, USA, .
authors.forename: De-Ke
authors.initials: DK
authors.lastname: Jiang
authors.affiliation: Center for Cancer Genomics, Wake Forest School of Medicine, Winston-Salem, North Carolina; Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, IL, USA.
authors.forename: S Lilly
authors.initials: SL
authors.lastname: Zheng
authors.affiliation: Fudan Institute of Urology, Huashan Hospital, Fudan University, Shanghai; Department of Urology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Hao-Wen
authors.initials: HW
authors.lastname: Jiang
authors.affiliation: Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Ying-Hao
authors.initials: YH
authors.lastname: Sun
authors.affiliation: Fudan Institute of Urology, Huashan Hospital, Fudan University, Shanghai; Department of Urology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Ding
authors.affiliation: Fudan Institute of Urology, Huashan Hospital, Fudan University, Shanghai, China; Department of Urology, Huashan Hospital, Fudan University, Shanghai, China; State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai, China; Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, IL, USA, .
authors.forename: Jianfeng
authors.initials: J
authors.lastname: Xu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D051517:Digital Rectal Examination; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011467:Prostate / Q000000981:diagnostic imaging / Q000473:pathology*; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000473:pathology; D014463:Ultrasonography / Q000379:methods