Table 1.
Overview of prostate cancer biomarker assays that are in development or have gained clinical approval. Pre-diagnostic biomarkers (blue), biomarkers used in biopsy-proven prostate cancer cases (yellow), predictive biomarkers (green). 3.4mt∆, 3.4-kb mitochondrial genome deletion; AR, androgen receptor; AR-V7, androgen receptor splice variant 7; BCR, biochemical recurrence; CTCs, circulating tumour cells; CTLA-4, cytotoxic T lymphocyte-associated protein-4; miRNA, microRNAs; PARP, poly (ADP-ribose) polymerase; PC, prostate cancer; PD-1, programmed death-1; PORTOS, Post-Operative Radiation Therapy Outcomes Score; PTEN, phosphatase and tensin homolog; RP, radical prostatectomy; RT, radiotherapy; sncRNAs, small non-coding RNAs; TMB, Tumour mutational burden.
| Test | Analyte | Analyte Source | Outcome Provided by Test |
|---|---|---|---|
| SelectMDX | mRNA | Urine | Probability of detecting PC after prostatic biopsy, tumour grade |
| TMPRSS2-ERG score | mRNA | Urine | Probability of detecting PC after prostatic biopsy, tumour grade |
| miR Sentinel PCa | sncRNAs | Urine | Distinguishes patients with PC from subject with no evidence of PC, tumour grade |
| ConfirmMDx | Methylated DNA | Prostatic biopsy tissue | Separates patients that have PC from those with a true negative biopsy result, tumour grade |
| PCA3 | mRNA | Urine | Probability of detecting PC after prostatic biopsy |
| Prostate Core Mitomic Test | 3.4mt∆ | Prostatic biopsy tissue | Resolves false from true-negative prostatic biopsy results |
| Oncotype DX Genomic Prostate Score | mRNA | Prostatic biopsy tissue | Tumour grade, BCR, metastasis, recurrence |
| Prolaris | mRNA | Prostatic biopsy tissue | Tumour aggressiveness, metastasis |
| ProMark | Protein | Prostatic biopsy tissue | Tumour aggressiveness |
| Decipher | mRNA | Primary tumour after RP, prostatic biopsy tissue | Tumour aggressiveness, BCR, metastasis |
| miR Sentinel CS/GH tests | sncRNAs | Urine | Tumour grade |
| Ki67 | Protein | Primary tumour after RP, prostatic biopsy tissue | BCR, metastasis, survival |
| miR risk score | miRNAs | Serum | Gleason score, BCR |
| PTEN | Protein | Prostatic biopsy tissue | Gleason score, stage, metastasis, BCR, recurrence |
| PORTOS | mRNA | Primary tumour after RP | Predict RT response |
| DNA repair defects | mRNA | Prostatic biopsy tissue | Predict response to PARP inhibitors |
| AR-V7 | Protein, mRNA | Prostatic biopsy tissue, CTCs | Predict resistance to AR signalling inhibitors or sensitivity to taxanes |
| CTLA-4 and PD-1 receptors, TMB | Protein, mRNA | Prostatic biopsy tissue, CTCs | Response to immunotherapy |