Table 3. Studies on diagnostic performance of PCA3.
| Author | Year | Number of patients | Endpoint | Outcome |
|---|---|---|---|---|
| Hessels et al [88] | 2003 | 108 | Ability to identify PCa | AUC: 0.72 (95% CI: 0.58, 0.85) |
| Tinzl et al [87] | 2004 | 201 | Ability to identify PCa | AUC: 0.87 (95% CI: 0.81, 0.92) |
| Groskopf et al [91] | 2006 | 143 | Ability to identify PCa | AUC: 0.746 (95% CI, 0.574, 0.918) |
| Chun et al [92] | 2009 | 1,206 | Predictive value of HGPC | AUC: 0.633 for PCA3 assay score cut-off threshold of 17; 0.624 for PCA3 cut-off of 24; 0.620 for PCA3 cut-off of 35 |
| Roobol et al [90] | 2010 | 721 | Diagnostic value of PCa | AUC: 0.635 (95% CI: 0.582, 0.689) |
| Pepe et al [93] | 2012 | 118 | Diagnosis ability in PCa with cut-off of 35 vs. 20 | AUC: 0.678 for PCA3 ≥20; 0.634 for PCA3 ≥35 |
| Klatte et al [94] | 2012 | 205 | Diagnostic value of PCa and impact of age | AUC: 0.754 (95% CI: 0.684, 0.824) for PCA3 alone; 0.771 (95% CI: 0.702, 0.840) with age-specific PCA3 score |
| Wu et al [95] | 2012 | 103 | Diagnostic value of PCa | AUC: 0.64 (95% CI: 0.53, 0.75) |
| Ferro et al [52] | 2012 | 251 | Diagnostic value of PCa | AUC: 0.71; sensitivity: 0.81 (95% CI: 0.68, 0.91); specificity: 0.57 (95% CI: 0.45, 0.69) |
| Crawford et al [96] | 2012 | 1,962 | Diagnostic value of PCa | AUC: 0.706 (95% CI: 0.673, 0.739) |
| Cornu et al [97] | 2013 | 291 | Diagnostic value of PCa | AUC: 0.66 (95% CI: 0.60, 0.72) |
| Scattoni et al [56] | 2013 | 211 | Diagnostic value of PCa | AUC: 0.69 (95% CI: 0.59, 0.79) in initial biopsy; 0.72 (95% CI: 0.59, 0.84) in repeat biopsy |
| Ruffion et al [98] | 2013 | 601 | Diagnostic value of PCa | AUC: 0.780 (95% CI: 0.743, 0.818) |
| Ferro et al [57] | 2013 | 300 | Diagnostic value of PCa | AUC: 0.73 (95% CI: 0.68, 0.79) |
| Ochiai et al [100] | 2013 | 647 | Diagnostic value of PCa in Asian men | AUC: 0.742; sensitivity 66.5%; specificity 71.6% |
| Chevli et al [99] | 2014 | 3,073 | Diagnostic value of PCa | AUC: 0.697 for all PCa; 0.682 for HGPC |
| Leyten et al [89] | 2014 | 497 | Diagnostic value of PCa | AUC: 0.720 (95% CI: 0.67, 0.77) in all PCa; 0.53 (95% CI: 0.44, 0.61) in patients Gleason score ≥7; 0.48 (95% CI: 0.39, 0.56) in patients clinical tumor stage T3–T4 |
| Vedder et al [33] | 2014 | 708 | Predictive value added to the ERSPC multivariable prediction models | AUC: 0.62 (95% CI: 0.52, 0.73) |
| Wei et al [101] | 2014 | 859 | Diagnostic value of PCa | PPV: 80% (95% CI: 72%, 86%); NPV: 88% (95% CI: 81%, 93%); AUC 0.79 for initial prostate biopsy of any cancer; 0.69 for repeat prostate biopsy of any cancer; 0.78 for initial prostate biopsy of high-grade cancer; 0.79 for repeat prostate biopsy of high-grade cancer AUC: 0.775 |
| Capoluongo et al [102] | 2014 | 734 | Evaluation diagnostic performance of PCA3 | AUC: 0.775 |
| Merola et al [103] | 2015 | 407 | Diagnostic value of PCa | AUC: 0.865 |
| Zheng et al [104] | 2015 | 52 | Diagnostic value of PCa | AUC: 0.831; sensitivity: 82.4%; specificity: 77.8% |
| Tomlins et al [105] | 2016 | 1,244 | Diagnostic value of HGPC | AUC: 0.726 |
| Feibus et al [106] | 2016 | 304 | Diagnostic value of PCa | AUC: 0.804 (95% CI: 0.752, 0.855) |
| Cantiello et al [48] | 2016 | 188 | Diagnostic value added to the Epstein criteria (Model 1: PSA density, number of positive cores and % of core involvement) | AUC: 0.77 (95% CI: 0.70, 0.83) for PCA3 add to the Epstein criteria |
| Cao et al [107] | 2018 | 271 | Diagnostic value of PCa | AUC: 0.729 (95% CI: 0.65, 0.78) |
| Ankerst et al [109] | 2019 | 1,225 | Diagnostic value of PCa | AUC: 0.713; 0.764 for updated for PCPTRC with PCA3 included: 0.771 for updated PCPTRC with both PCA3 and T2:ERG included |
| Newcomb et al [110] | 2019 | 782 | Diagnostic value of PCa | AUC: 0.611 (95% CI: 0.553, 0.668) |
| Gan et al [108] | 2022 | 124 | Diagnostic value of PCa | AUC: 0.7829 (95% CI: 0.7021, 0.8633) |
AUC: area under the curve, CI: confidence interval, ERSPC: European Randomized Study of Screening for Prostate Cancer, HGPC: high-grade prostate cancer, NPV: negative predictive value, PCa: prostate cancer, PCA3: prostate cancer antigen 3, PCPTRC: Prostate Cancer Prevention Trial Risk Calculator, PPV: positive predictive value.