Table 2. Commercially available prostate cancer genomic and proteomic assays to assist in clinical decision making.
| Test | Patient criteria | Details | Prognostic predictor |
|---|---|---|---|
| Stockholm 3 (56) | Age 50 to 70 and must not previously had diagnosis of prostate cancer | Panel of plasma biomarkers, 232 genetic polymorphisms in association with clinical variables | Improves diagnostic specificity for detection of prostate cancer of Gleason score 7 or greater |
| Prolaris (57) | Low to intermediate National Comprehensive Cancer Network (NCCN) risk (58) | 31 RNA expression profiles implicated in cell cycle progression genes using tissue samples in combination with PSA and Gleason score | 10-year disease specific mortality risk. Aggressive disease. 10-year biochemical recurrence risk |
| OncotypeDx Genomic Prostate score (59) | Low to intermediate NCCN risk | RNA expression using tissue samples in combination with PSA, TMN staging and Gleason score | 10-year disease specific mortality and metastatic risk. Aggressive disease |
| ConfirmMDx (60) | Previous negative biopsy | Methylation-specific quantitative polymerase chain reaction in combination with PSA, TMN staging and Gleason score | Improves negative predictive value of repeat biopsy |
| Progensa PCA3 (61) | Previous negative biopsy | RNA ratio of PCA3 RNA to PSA RNA in urine combined with PSA, DRE, age and prostate size | Improves negative predictive value of repeat biopsy |
| 4K Score (62) | Negative or no previous biopsy | A panel of four Kallikrein protein in combination with clinical information | 20-year disease specific mortality risk. 10-year metastatic risk. Aggressive disease |
| Decipher (63) | Low to intermediate NCCN risk or Post-radical prostatectomy with positive surgical margins, pT3a disease, pT4 disease or biochemical recurrence on PSA | RNA expression using tissue samples in combination with PSA, TMN staging and Gleason score | 10-year disease specific mortality risk. 5-year metastatic risk. Aggressive disease |
| OncotypeDx AR-V7 Nucleus test (64) | mCRPC patients | AR-V7 protein | AR-V7 variant detection |
| ProstaVysion (65) | Must have had biopsy or prostatectomy | ERG gene fusion/translocation or PTEN deletion using tissue samples in combination with PSA, TMN staging and Gleason score | Disease specific mortality risk and aggressive disease |
| Promark (66) | Gleason 3+3 and 3+4 | A panel of eight proteins using tissue samples in combination with PSA, TMN staging and Gleason score | Risk of aggressive disease |
PSA, prostate specific antigen; mCRPC, metastatic castration-resistant prostate cancer; DRE, digital rectal examination; PTEN, phosphatase and tensin homolog.