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Objectives  To investigate and further validate if two novel cancer‐related glycoproteins, discovered by a genetic‐guided proteomics approach, can distinguish benign disease from prostate cancer ( PC a) in men with enlarged prostates.    Patients and Methods  A retrospective study was performed that included men with a total prostate‐specific antigen ( PSA ) concentration of 2.0–10 ng/mL, negative digital rectal examination and enlarged prostate (volume ≥35 mL). Serum samples were collected between 2011 and 2016 at a single centre from 474 men before they underwent prostate biopsy. Serum concentrations of thrombospondin 1 ( THBS 1) and cathepsin D ( CTSD ) glycoproteins were combined with the percentage of free PSA to total  PSA  ratio (% fPSA ) to predict any or significant cancer at biopsy.    Results  The multivariable logistic regression model including  THBS 1,  CTSD  and % fPSA  discriminated among biopsy‐positive and biopsy‐negative patients in the validation set with an area under the curve ( AUC ) of 0.86 ( P  < 0.001, 95% confidence interval ( CI ) 0.82–0.91), while % fPSA  alone showed an  AUC  of 0.64 ( P  < 0.001, 95%  CI  0.57–0.71). At 90% sensitivity for  PC a, the specificity of the model was 62%, while % fPSA  had a specificity of 23%. For high grade (Gleason score ≥ 7 in prostatectomy specimen)  PC a, the specificity was 48% at 90% sensitivity, with an  AUC  of 0.83, ( P  < 0.001, 95%  CI  0.77 to 0.88). Limitations of the study include the retrospective set‐up and single‐centre cohort.    Conclusions  A model combining two cancer‐related glycoproteins ( THBS 1 and  CTSD ) and % fPSA  can improve  PC a diagnosis and may reduce the number of unnecessary prostate biopsies because of its improved specificity for  PC a when compared to % fPSA  alone.

Thrombospondin 1 and cathepsin D improve prostate cancer diagnosis by avoiding potentially unnecessary prostate biopsies