Table 1.
Potential clinical utility, characteristics, and availability of prostate cancer biomarkers.
| Biomarker Test | Molecular Markers | Potential Clinical Utility | Characteristics | Availability |
|---|---|---|---|---|
| Serum biomarkers | ||||
| PSA | PSA | Treatment monitoring | Sensitivity: 60% [18] Specificity: 79% [18] AUC: 0.55 [19] |
|
| 4KScore | Total PSA, free PSA, intact PSA, hK2 | Unnecessary biopsy reduction of 43% [20] Risk prediction of PCa metastases Previous negative biopsy |
Sensitivity: 75% [21] Specificity: 63% [21] AUC: 0.71 [22] |
CLIA-certified |
| PHI | Total PSA, free PSA, p2PSA isoform | Unnecessary biopsy reduction of 40% [23] Prediction of high-grade PCa Active supervision monitoring |
Sensitivity: 82% [24] Specificity: 80% [24] AUC: 0.71 [21] |
FDA-approved |
| Urinary biomarkers | ||||
| Progensa (PCA3) | Long non-coding RNAs (ratio of PCA3 mRNA:PSA mRNA) | Unnecessary biopsy reduction of 23–38% [25] PCa detection, staging, and prognosis Previous negative biopsy |
Sensitivity: 69% [26] Specificity: 65% [26] AUC: 0.73 [26] |
FDA-approved |
| SelectMDx | HOXC6 and DLX1 mRNA | Unnecessary biopsy reduction of 53% [27] Prediction of high-grade PCa |
Sensitivity: 91% [27] Specificity: 36% [27] AUC: 0.71–0.81 [27] |
CLIA-certified |
| MPS | PCA3 and TMPRSS2-ERG mRNA | Unnecessary biopsy reduction of 35–47% [28] Predict the risk of PCa and high-grade PCa |
Sensitivity: 93% [29] Specificity: 33% [29] AUC: 0.69 [28] |
CLIA-certified |
| EPI | Exosomal RNA (SPDEF, PCA3, ERG) | Unnecessary biopsy reduction of 27% [30] Improved identification of high-grade PCa |
Sensitivity: 92% [30] Specificity: 34% [30] AUC: 0.70 [30] |
CLIA-certified |
| Tissue biomarkers | ||||
| ConfirmMDx | DNA hypermethylation GSTP1, APC, and RASSF1 | Prediction of true negative prostate biopsies | Sensitivity: 68% [24] Specificity: 64% [24] AUC: 0.74 [24] |
Not FDA-approved yet |
| OncotypeDX | mRNA expression (17 genes) | Monitoring of tumor aggressiveness | AUC: 0.73 [26] | Not FDA-approved yet |
| Prolaris | mRNA expression (31 genes) | Monitoring of tumor aggressiveness | AUC: 0.78 [26] | FDA-approved |
| Decipher | mRNA expression (22 genes) | Treatment monitoring | Sensitivity: 73% [31] Specificity: 74% [31] AUC: 0.79 [31] |
CLIA-certified |
| ProMark | Protein biomarker test (8 proteins) | Monitoring of tumor aggressiveness | Sensitivity: 90% [27] Specificity: 85% [27] AUC: 0.72 [27] |
CLIA-certified |
Legend: AUC—area under the receiver operating characteristic (ROC) curve; CLIA—Clinical Laboratory Improvement Amendments; FDA—Food and Drug Administration.