title: Performance of serum prostate-specific antigen isoform [-2]proPSA (p2PSA) and the prostate health index (PHI) in a Chinese hospital-based biopsy population.
abstract: BACKGROUND
  The use of serum [-2]proPSA (p2PSA) and its derivative, the prostate health index (PHI), in detecting prostate cancer (PCa) have been consistently shown to have better performance than total prostate-specific antigen (tPSA) in discriminating biopsy outcomes in western countries. However, little is known about their performance in Chinese men. Our objective is to test the performance of p2PSA and PHI and their added value to tPSA in discriminating biopsy outcomes in Chinese men.
  
  
  METHODS
  Consecutive patients who underwent prostate biopsy in three tertiary hospitals in Shanghai, China during 2012-2013 were recruited. Serum tPSA, free PSA (fPSA), and p2PSA were measured centrally using Beckman Coulter's DxI 800 Immunoassay System. The primary outcome is PCa and the secondary outcome is high-grade PCa (Gleason Score of 4 + 3 or worse). Discriminative performance was assessed using the area under the receiver operating characteristic curve (AUC), detection rate and Decision Curve Analysis (DCA).
  
  
  RESULTS
  Among 636 patients who underwent prostate biopsy, PHI was a significant predictor of biopsy outcomes, independent of other clinical variables. The AUC in discriminating PCa from non-PCa was consistently higher for PHI than tPSA in the entire cohort (0.88 vs. 0.81) as well as in patients with tPSA at 2-10 ng/ml (0.73 vs. 0.53), at 10.1-20 ng/ml (0.81 vs. 0.58), and at tPSA >20 ng/ml (0.90 vs. 0.80). The differences were statistically significant in all comparisons, P < 0.01. To detect 90% of all PCa in the cohort, 362 and 457 patients would need to be biopsied based on PHI and tPSA cutoff, respectively, a 21% reduction for PHI. Similar results were found for discriminating high-grade PCa.
  
  
  CONCLUSIONS
  PHI provides added value over tPSA in discriminating PCa and high-grade PCa in patients who underwent prostate biopsy in China.
authors.affiliation: Fudan Institute of Urology, Fudan University, Shanghai, China; Department of Urology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Rong
authors.initials: R
authors.lastname: Na
authors.forename: Dingwei
authors.initials: D
authors.lastname: Ye
authors.forename: Fang
authors.initials: F
authors.lastname: Liu
authors.forename: Haitao
authors.initials: H
authors.lastname: Chen
authors.forename: Jun
authors.initials: J
authors.lastname: Qi
authors.forename: Yishuo
authors.initials: Y
authors.lastname: Wu
authors.forename: Guiming
authors.initials: G
authors.lastname: Zhang
authors.forename: Meilin
authors.initials: M
authors.lastname: Wang
authors.forename: Wenying
authors.initials: W
authors.lastname: Wang
authors.forename: Jielin
authors.initials: J
authors.lastname: Sun
authors.forename: Guopeng
authors.initials: G
authors.lastname: Yu
authors.forename: Yao
authors.initials: Y
authors.lastname: Zhu
authors.forename: Shancheng
authors.initials: S
authors.lastname: Ren
authors.forename: S Lilly
authors.initials: SL
authors.lastname: Zheng
authors.forename: Haowen
authors.initials: H
authors.lastname: Jiang
authors.forename: Yinghao
authors.initials: Y
authors.lastname: Sun
authors.forename: Qiang
authors.initials: Q
authors.lastname: Ding
authors.forename: Jianfeng
authors.initials: J
authors.lastname: Xu
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D014408:Biomarkers, Tumor / Q000097:blood*; D001706:Biopsy; D002681:China; D006801:Humans; D007118:Immunoassay; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D011467:Prostate / Q000473:pathology*; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000473:pathology; D020033:Protein Isoforms; D012372:ROC Curve; D012720:Severity of Illness Index
chemical_list: D014408:Biomarkers, Tumor; D020033:Protein Isoforms; D017430:Prostate-Specific Antigen
keywords: PSA; [-2]proPSA (p2PSA); prostate cancer; prostate health index (PHI); receiver operating curve (ROC)