title: Risk assessment models to evaluate the necessity of prostate biopsies in North Chinese patients with 4-50 ng/mL PSA.
abstract: BACKGROUND
  Prostate-specific antigen (PSA) is widely used for prostate cancer screening, but low specificity results in high false positive rates of prostate biopsies.
  
  
  OBJECTIVE
  To develop new risk assessment models to overcome the diagnostic limitation of PSA and reduce unnecessary prostate biopsies in North Chinese patients with 4-50 ng/mL PSA.
  
  
  METHODS
  A total of 702 patients in seven hospitals with 4-10 and 10-50 ng/mL PSA, respectively, who had undergone transrectal ultrasound-guided prostate biopsies, were assessed. Analysis-modeling stage for several clinical indexes related to prostate cancer and renal function was carried out. Multiple logistic regression analyses were used to develop new risk assessment models of prostate cancer for both PSA level ranges 4-10 and 10-50 ng/mL. External validation stage of the new models was performed to assess the necessity of biopsy.
  
  
  RESULTS
  The new models for both PSA ranges performed significantly better than PSA for detecting prostate cancers. Both models showed higher areas under the curves (0.937 and 0.873, respectively) compared with PSA alone (0.624 and 0.595), at pre-determined cut-off values of 0.1067 and 0.6183, respectively. Patients above the cut-off values were recommended for immediate biopsy, while the others were actively observed. External validation of the models showed significantly increased detection rates for prostate cancer (4-10 ng/mL group, 39.29% vs 17.79%, p=0.006; 10-50 ng/mL group, 71.83% vs 50.0%, p=0.015).
  
  
  CONCLUSIONS
  We developed risk assessment models for North Chinese patients with 4-50 ng/mL PSA to reduce unnecessary prostate biopsies and increase the detection rate of prostate cancer.
authors.affiliation: Department of Urology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, People's Republic of China.
authors.forename: Jing
authors.initials: J
authors.lastname: Zhao
authors.affiliation: Department of Urology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, People's Republic of China.
authors.forename: Shuai
authors.initials: S
authors.lastname: Liu
authors.affiliation: Department of Urology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, People's Republic of China.
authors.forename: Dexuan
authors.initials: D
authors.lastname: Gao
authors.affiliation: Department of Urology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, People's Republic of China.
authors.forename: Sentai
authors.initials: S
authors.lastname: Ding
authors.affiliation: Department of Urology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, People's Republic of China.
authors.forename: Zhihong
authors.initials: Z
authors.lastname: Niu
authors.affiliation: Department of Urology, Shandong Provincial Hospital Affiliated to Shandong University (East Branch), Jinan, People's Republic of China.
authors.forename: Hui
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Department of Urology, Lanling People's Hospital, Lanling, People's Republic of China.
authors.forename: Zhilong
authors.initials: Z
authors.lastname: Huang
authors.affiliation: Department of Urology, Dongying People's Hospital, Dongying, People's Republic of China.
authors.forename: Juhui
authors.initials: J
authors.lastname: Qiu
authors.affiliation: Department of Urology, Yucheng People's Hospital, Yucheng, People's Republic of China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Urology, Guangrao County Hospital of traditional Chinese Medicine, Guangrao, People's Republic of China.
authors.forename: Ning
authors.initials: N
authors.lastname: Li
authors.affiliation: Department of Urology, Weihai Municipal Hospital, Weihai, People's Republic of China.
authors.forename: Fang
authors.initials: F
authors.lastname: Xie
authors.affiliation: Department of Urology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, People's Republic of China.
authors.forename: Jilei
authors.initials: J
authors.lastname: Cui
authors.affiliation: Department of Urology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, People's Republic of China.
authors.forename: Jiaju
authors.initials: J
authors.lastname: Lu
mesh_terms: D000368:Aged; D019540:Area Under Curve; D016009:Chi-Square Distribution; D002681:China; D000066491:Clinical Decision-Making; D003661:Decision Support Techniques; D006801:Humans; D061705:Image-Guided Biopsy; D007610:Kallikreins / Q000097:blood*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D049451:Nomograms; D016017:Odds Ratio; D018579:Patient Selection; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000473:pathology*; D012372:ROC Curve; D015203:Reproducibility of Results; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D019564:Unnecessary Procedures; D057832:Watchful Waiting
chemical_list: C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen
keywords: North China; PSA; biopsy; prostate cancer; risk assessment model