Prostate Genomic Cancer Testing
Available multigene tests for prostate cancer include myRisk (Myriad), Colon hereditary cancer test (Color; Genome Dx), Prostate cancer panel (Invitae), Hereditary prostate cancer panel (Opko/GeneDx), Prostate Next (Ambry)
A 2018 study shows how prostate cancer has multiple genetic foci and care should be taken when using biopsy results to stratify due to sampling error. (2)
Decipher Tissue based genomic test for use on post RP to help adjuvant therapy recommendations. 7 studies have shown usefulness after RP, none after a biopsy in 2 excellent quality (37,39) and 4 high quality studies (38,40,41,42,43). Changes in decisions occurred in up to 61% of salvage patients and ~30-50% of adjuvant patients (37-43, 46-61)
Oncotype Tissue based genomic test used after positive prostate biopsy. There are two studies showing clinical usefulness demonstrating a 20-25% reduction in interventions. (35,36,66-70)
Prolaris Tissue based post biopsy or RP sample. Measures cell cycle progression in 46 genes to predict mortality and progression. 5 studies have shown clinical utility in post biopsy (28,29,30,31,32) and 1 post RP. (33) Up to 65% altered treatment recommendation with mostly less interventions (28) and 48% change in treatment recommendations, mostly for less intervention (30,71-77)
Confirm MDx Measures methylation levels of 3 genes. There is one good quality article showing reduced need for repeat biopsy. (27)
Progensa PCA3 - Urine sample. Non-coding MRNA overexpressed in PCa tissue. FDA approved for men >50yrs w/ 1 or more negative biopsy. 25 is cutoff for positive score in men w/ PSA >3ng/ml. Several studies have reported reduction in biopsies of 37-77% (21,22,23,24,25,26) depending on the cutoff level (25-35) with a missed diagnoses of 21% (24,25). Overall two excellent quality studies (21,22) and 4 good quality studies have shown effectiveness. (23,24,25,26)
4Kscore - Serum sample required, first published in 2008. (12) Combination of total, free, intact PSA and human kallikrein 2 with clinical information. Predicts likelihood of metastatic disease in next 20 years in otherwise healthy men who have PSA >1.99 ng/ml. Useful in predicting risk of Gleason 7 or greater. The largest study of 1241 Swedish men showed 4K score of <7.5% had a 1% chance of mPCa and 1.8% mPCa at 15 and 20 years respectively (13). At least 10 studies have been published showing its efficacy. (4,5,6,7,8,9,10,11,12,13) These studies show various levels of decreased biopsies 36% (5), 64% (6), 49% (7), 82% (9), 25% (10), 51% (11) and 41% (64). The highest quality studies show a reduction in unnecessary biopsies between 41-57% (9,11,12,13)
Prostate Health Index (PHI) - Serum sample required, first published in 2013. (14) An isoform of pro-PSA w/ two amino acids has been proven to be elevated in PCa tissues. PHI uses this and free and total PSA to generate phi score. PHI is FDA approved for PSA of 4-10ng/ml and NCCN endorses >35 phi score useful in patients with no or negative prior prostate biopsy. Studies have shown this to have greater predictive ability than %fPSA, total PSA. Studies report different cutoff levels, with higher levels resulting in less biopsies with the risk of missing prostate cancer. Multiple studies show ~10% risk of missed prostate cancer with a 15-45% reduced biopsy rate. Overall there are two excellent studies (14,15) and 5 good quality. (16,17,18,19,20) showing reduced need for biopsy.
Ki-67 - IHC (62-65)
Select MDx - urine sample. Measures mRNA levels of DLX1 and HOXC6. Useful in predicting high risk cancer.
TMPRSS2:ERG - urine sample. Fusion protein. Improved accuracy vs. tPSA
MiPS - urine sample. PCA3 + TMPRSS2:ERG + tPSA
ExoDx Prostate Intelliscore - urine sample. Exosomal RNA or PCA3, TMPRSS2:ERG, SPDEF. Useful to differentiate low and high grade cancers
ProMark - biopsy based test of 8 protein markers to predict aggressiveness. There is one study showing clinical utility. (34)
NADiA ProsVue - Serum based rate of PSA change from 3 very low concentration PSA tests after RP. There is 1 high quality study showing clinical usefulness. (44)
PTEN - FISH or IHC (78-82)
Most common tests characteristics:
Urine sample: PCA3, Selects MDx,
Serum sample: 4K, PHI
Before biopsy: 4Kscore, Select MDX, phi
After negative biopsy: PHI, 4K
After positive biopsy:prolaris, oncotype
After prostatectomy: prolaris, decipher
GEMCaP is DNA based biomarker that 2018 data of 140 patients post prostatectomy showed if 20% or higher of genomic loci show copy number gain or loss in a tumor predicts risk of BCR by HR of 2.69. (1)
A 2018 study shows how prostate cancer has multiple genetic foci and care should be taken when using biopsy results to stratify due to sampling error. (2)
Decipher Tissue based genomic test for use on post RP to help adjuvant therapy recommendations. 7 studies have shown usefulness after RP, none after a biopsy in 2 excellent quality (37,39) and 4 high quality studies (38,40,41,42,43). Changes in decisions occurred in up to 61% of salvage patients and ~30-50% of adjuvant patients (37-43, 46-61)
Oncotype Tissue based genomic test used after positive prostate biopsy. There are two studies showing clinical usefulness demonstrating a 20-25% reduction in interventions. (35,36,66-70)
Prolaris Tissue based post biopsy or RP sample. Measures cell cycle progression in 46 genes to predict mortality and progression. 5 studies have shown clinical utility in post biopsy (28,29,30,31,32) and 1 post RP. (33) Up to 65% altered treatment recommendation with mostly less interventions (28) and 48% change in treatment recommendations, mostly for less intervention (30,71-77)
Confirm MDx Measures methylation levels of 3 genes. There is one good quality article showing reduced need for repeat biopsy. (27)
Progensa PCA3 - Urine sample. Non-coding MRNA overexpressed in PCa tissue. FDA approved for men >50yrs w/ 1 or more negative biopsy. 25 is cutoff for positive score in men w/ PSA >3ng/ml. Several studies have reported reduction in biopsies of 37-77% (21,22,23,24,25,26) depending on the cutoff level (25-35) with a missed diagnoses of 21% (24,25). Overall two excellent quality studies (21,22) and 4 good quality studies have shown effectiveness. (23,24,25,26)
4Kscore - Serum sample required, first published in 2008. (12) Combination of total, free, intact PSA and human kallikrein 2 with clinical information. Predicts likelihood of metastatic disease in next 20 years in otherwise healthy men who have PSA >1.99 ng/ml. Useful in predicting risk of Gleason 7 or greater. The largest study of 1241 Swedish men showed 4K score of <7.5% had a 1% chance of mPCa and 1.8% mPCa at 15 and 20 years respectively (13). At least 10 studies have been published showing its efficacy. (4,5,6,7,8,9,10,11,12,13) These studies show various levels of decreased biopsies 36% (5), 64% (6), 49% (7), 82% (9), 25% (10), 51% (11) and 41% (64). The highest quality studies show a reduction in unnecessary biopsies between 41-57% (9,11,12,13)
Prostate Health Index (PHI) - Serum sample required, first published in 2013. (14) An isoform of pro-PSA w/ two amino acids has been proven to be elevated in PCa tissues. PHI uses this and free and total PSA to generate phi score. PHI is FDA approved for PSA of 4-10ng/ml and NCCN endorses >35 phi score useful in patients with no or negative prior prostate biopsy. Studies have shown this to have greater predictive ability than %fPSA, total PSA. Studies report different cutoff levels, with higher levels resulting in less biopsies with the risk of missing prostate cancer. Multiple studies show ~10% risk of missed prostate cancer with a 15-45% reduced biopsy rate. Overall there are two excellent studies (14,15) and 5 good quality. (16,17,18,19,20) showing reduced need for biopsy.
Ki-67 - IHC (62-65)
Select MDx - urine sample. Measures mRNA levels of DLX1 and HOXC6. Useful in predicting high risk cancer.
TMPRSS2:ERG - urine sample. Fusion protein. Improved accuracy vs. tPSA
MiPS - urine sample. PCA3 + TMPRSS2:ERG + tPSA
ExoDx Prostate Intelliscore - urine sample. Exosomal RNA or PCA3, TMPRSS2:ERG, SPDEF. Useful to differentiate low and high grade cancers
ProMark - biopsy based test of 8 protein markers to predict aggressiveness. There is one study showing clinical utility. (34)
NADiA ProsVue - Serum based rate of PSA change from 3 very low concentration PSA tests after RP. There is 1 high quality study showing clinical usefulness. (44)
PTEN - FISH or IHC (78-82)
Most common tests characteristics:
Urine sample: PCA3, Selects MDx,
Serum sample: 4K, PHI
Before biopsy: 4Kscore, Select MDX, phi
After negative biopsy: PHI, 4K
After positive biopsy:prolaris, oncotype
After prostatectomy: prolaris, decipher
GEMCaP is DNA based biomarker that 2018 data of 140 patients post prostatectomy showed if 20% or higher of genomic loci show copy number gain or loss in a tumor predicts risk of BCR by HR of 2.69. (1)
Table 1 Genomic Tests for Prostate Cancer
Value |
Decipher |
Oncotype DX |
Prolaris |
Promark |
Platform |
Gene expression |
Gene expression |
Gene expression |
Quantitative multiplex proteomic imagins |
Pathways |
Proliferation, Adhesion, Motility, Cell cycle, Immune Modulation, Androgen Signaling |
Androgen Signaling, Cell Organization, Stromal Response, Proliferation |
Proliferation |
ER, Cytoskeleton, Cell Signaling, Metabolism, Stress Response, mRNA, Splicing, Protein Synthesis |
Encouraging Results |
<0.2 |
<80% freedom from primary gleason 4 |
<3% chance of prostate cancer mortality |
Table 2 Outcomes Predicted for
High Grade |
+ |
+ |
- |
- |
Non-organ confined |
- |
+ |
- |
- |
Adverse Pathology |
- |
+ |
- |
+ |
PSA Failure |
- |
+ |
+ |
- |
Metastasis |
+ |
+ |
+ |
- |
Death |
+ |
+ |
+ |
- |
Table 3 Germline DNA Testing Panels
Company |
Panel Name |
Number of Genes Tested |
Ambry Genetics |
ProstateNext |
14 |
Fulgent |
Prostate Cancer Panel |
11 |
GeneDx |
Prostate Cancer Panel |
12 |
Invitae |
Prostate Cancer Panel |
14 |
NeoGenomics |
Hereditary DNA Repair Panel for Prostate Cancer |
20 |
Nuclear pore complex POM 121 has been identified as related to prostate cancer agressiveness and may be a biomarker in future. (3)
- Nguyen, Hao G., et al. "Validation of GEMCaP as a DNA Based Biomarker to Predict Prostate Cancer Recurrence after Radical Prostatectomy." The Journal of urology 199.3 (2018): 719-725.
- Wei, Lei, et al. "Intratumoral and intertumoral genomic heterogeneity of multifocal localized prostate cancer impacts molecular classifications and genomic prognosticators." European urology 71.2 (2017): 183-192.
- Rodriguez-Bravo, Veronica, et al. "Nuclear pores promote lethal prostate cancer by increasing POM121-driven E2F1, MYC, and AR nuclear import." Cell 174.5 (2018): 1200-1215.
- Carlsson, Sigrid, et al. "Predictive value of four kallikrein markers for pathologically insignificant compared with aggressive prostate cancer in radical prostatectomy specimens: results from the European Randomized Study of Screening for Prostate Cancer section Rotterdam." European urology 64.5 (2013): 693-699.
- Vickers, Andrew J., et al. "A four-kallikrein panel predicts prostate cancer in men with recent screening: data from the European Randomized Study of Screening for Prostate Cancer, Rotterdam." Clinical Cancer Research (2010): 1078-0432.
- Konety, Badrinath, et al. "The 4Kscore® test reduces prostate biopsy rates in community and academic urology practices." Reviews in urology 17.4 (2015): 231.
- Benchikh, Amine, et al. "A panel of kallikrein markers can predict outcome of prostate biopsy following clinical work-up: an independent validation study from the European Randomized Study of Prostate Cancer screening, France." BMC cancer 10.1 (2010): 635.
- Braun, Katharina, et al. "A four-kallikrein panel predicts high-grade cancer on biopsy: independent validation in a community cohort." European urology 69.3 (2016): 505-511.
- Gupta, Alok, et al. "A four-kallikrein panel for the prediction of repeat prostate biopsy: data from the European Randomized Study of Prostate Cancer screening in Rotterdam, Netherlands." British journal of cancer 103.5 (2010): 708.
- Lin, Daniel W., et al. "Evaluating the Four Kallikrein Panel of the 4Kscore for prediction of high-grade prostate cancer in men in the canary prostate active surveillance study." European urology 72.3 (2017): 448-454.
- Vickers, Andrew, et al. "Reducing unnecessary biopsy during prostate cancer screening using a four-kallikrein panel: an independent replication." Journal of Clinical Oncology 28.15 (2010): 2493.
- Vickers, Andrew J., et al. "A panel of kallikrein markers can reduce unnecessary biopsy for prostate cancer: data from the European Randomized Study of Prostate Cancer Screening in Göteborg, Sweden." BMC medicine 6.1 (2008): 19.
- Vickers, Andrew J., et al. "Impact of recent screening on predicting the outcome of prostate cancer biopsy in men with elevated prostate‐specific antigen: Data from the European Randomized Study of Prostate Cancer Screening in Gothenburg, Sweden." Cancer: Interdisciplinary International Journal of the American Cancer Society 116.11 (2010): 2612-2620.
- Lazzeri, Massimo, et al. "Serum isoform [− 2] proPSA derivatives significantly improve prediction of prostate cancer at initial biopsy in a total PSA range of 2–10 ng/ml: a multicentric European study." European urology 63.6 (2013): 986-994.
- Ng, C. F., et al. "The Prostate Health Index in predicting initial prostate biopsy outcomes in Asian men with prostate-specific antigen levels of 4–10 ng/mL." International urology and nephrology 46.4 (2014): 711-717.
- Hirama, Hiromi, et al. "The impact of baseline [− 2] proPSA-related indices on the prediction of pathological reclassification at 1 year during active surveillance for low-risk prostate cancer: the Japanese multicenter study cohort." Journal of cancer research and clinical oncology 140.2 (2014): 257-263.
- Filella, Xavier, et al. "Clinical utility of% p2PSA and prostate health index in the detection of prostate cancer." Clinical Chemistry and Laboratory Medicine (CCLM) 52.9 (2014): 1347-1355.
- Foley, Robert W., et al. "Improving multivariable prostate cancer risk assessment using the Prostate Health Index." BJU international 117.3 (2016): 409-417.
- Gnanapragasam, Vincent Jeyaseelan, et al. "The Prostate Health Index adds predictive value to multi-parametric MRI in detecting significant prostate cancers in a repeat biopsy population." Scientific reports 6 (2016): 35364.
- Lazzeri, Massimo, et al. "Clinical performance of serum prostate‐specific antigen isoform [‐2] proPSA (p2PSA) and its derivatives,% p2PSA and the prostate health index (PHI), in men with a family history of prostate cancer: results from a multicentre E uropean study, the PROMEtheuS project." BJU international 112.3 (2013): 313-321.
- Gittelman, Marc C., et al. "PCA3 molecular urine test as a predictor of repeat prostate biopsy outcome in men with previous negative biopsies: a prospective multicenter clinical study." The Journal of urology 190.1 (2013): 64-69.
- Malavaud, Bernard, et al. "Impact of adoption of a decision algorithm including PCA3 for repeat biopsy on the costs for prostate cancer diagnosis in France." Journal of medical economics 16.3 (2013): 358-363.
- Crawford, E. David, et al. "Diagnostic performance of PCA3 to detect prostate cancer in men with increased prostate specific antigen: a prospective study of 1,962 cases." The Journal of urology 188.5 (2012): 1726-1731.
- de la Taille, Alexandre, et al. "Clinical evaluation of the PCA3 assay in guiding initial biopsy decisions." The Journal of urology 185.6 (2011): 2119-2125.
- Haese, Alexander, et al. "Clinical utility of the PCA3 urine assay in European men scheduled for repeat biopsy." European urology 54.5 (2008): 1081-1088.
- Tombal, Bertrand, et al. "Clinical judgment versus biomarker prostate cancer gene 3: which is best when determining the need for repeat prostate biopsy?." Urology 81.5 (2013): 998-1004.
- Wojno, Kirk J., et al. "Reduced rate of repeated prostate biopsies observed in ConfirmMDx clinical utility field study." American health & drug benefits 7.3 (2014): 129.
- Crawford, E. David, et al. "Cell cycle progression score and treatment decisions in prostate cancer: results from an ongoing registry." Current medical research and opinion 30.6 (2014): 1025-1031.
- Shore, Neal, et al. "Clinical utility of a biopsy-based cell cycle gene expression assay in localized prostate cancer." Current medical research and opinion 30.4 (2014): 547-553.
- Shore, Neal D., et al. "Impact of the cell cycle progression test on physician and patient treatment selection for localized prostate cancer." The Journal of urology 195.3 (2016): 612-618.
- Oderda, Marco, et al. "Cell-cycle progression-score might improve the current risk assessment in newly diagnosed prostate cancer patients." Urology 102 (2017): 73-78.
- Cuzick, J., et al. "Validation of an RNA cell cycle progression score for predicting death from prostate cancer in a conservatively managed needle biopsy cohort." British journal of cancer 113.3 (2015): 382.
- Cooperberg, Matthew R., et al. "Validation of a cell-cycle progression gene panel to improve risk stratification in a contemporary prostatectomy cohort." (2013): 1428-1434.
- Blume-Jensen, Peter, et al. "Development and clinical validation of an in situ biopsy-based multimarker assay for risk stratification in prostate cancer." Clinical cancer research(2015).
- Albala, David, et al. "Health Economic Impact and Prospective Clinical Utility of Oncotype DX® Genomic Prostate Score." Reviews in urology 18.3 (2016): 123.
- Dall’Era, Marc A., et al. "Utility of the oncotype DX® prostate cancer assay in clinical practice for treatment selection in men newly diagnosed with prostate cancer: a retrospective chart review analysis." Urology Practice 2.6 (2015): 343-348.
- Badani, Ketan, et al. "Impact of a genomic classifier of metastatic risk on postoperative treatment recommendations for prostate cancer patients: a report from the DECIDE study group." Oncotarget 4.4 (2013): 600.
- Badani, Ketan K., et al. "Effect of a genomic classifier test on clinical practice decisions for patients with high‐risk prostate cancer after surgery." BJU international 115.3 (2015): 419-429.
- Michalopoulos, Steven N., et al. "Influence of a genomic classifier on post-operative treatment decisions in high-risk prostate cancer patients: results from the PRO-ACT study." Current medical research and opinion 30.8 (2014): 1547-1556.
- Nguyen, Paul L., et al. "Impact of a genomic classifier of metastatic risk on postprostatectomy treatment recommendations by radiation oncologists and urologists." Urology 86.1 (2015): 35-40.
- Cooperberg, Matthew R., et al. "Combined value of validated clinical and genomic risk stratification tools for predicting prostate cancer mortality in a high-risk prostatectomy cohort." European urology 67.2 (2015): 326-333.
- Den, R. B., et al. "Decipher correlation patterns post prostatectomy: initial experience from 2 342 prospective patients." Prostate cancer and prostatic diseases 19.4 (2016): 374.
- Ross, Ashley E., et al. "Tissue-based genomics augments post-prostatectomy risk stratification in a natural history cohort of intermediate-and high-risk men." European urology 69.1 (2016): 157-165.
- Moul, J. W., et al. "Impact of NADiA ProsVue PSA slope on secondary treatment decisions after radical prostatectomy." Prostate cancer and prostatic diseases 17.3 (2014): 280.
- https://jnccn.org/view/journals/jnccn/17/5/article-p479.xml
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