Molecular Risk Assessment for Prostate Cancer

A myriad of molecular-based risk assessment tests derived from serum, urine, and tissue have emerged to improve the specificity for detection and stratification of clinically significant prostate cancer.

Tests can be categorized into three main functions depending on their use in prostate cancer management. Tests can assist clinicians in determining: (1) who to biopsy, (2) when to re-biopsy, and (3) who to offer therapy.

Serum-Based Tests

• 4Kscore — The 4Kscore combines four prostate-specific biomarkers with clinical information to provide men with an accurate and personalized measure of their risk for aggressive prostate cancer. The 4Kscore can be used prior to biopsy, or after a negative biopsy, and can predict the likelihood of cancer spreading to other parts of the body in the next 20 years.
• Prostate Health Index (phi) — The Prostate Health Index (phi) measures 3 different types of PSA (prostate-specific antigen) and is a more accurate way to assess prostate cancer risk than PSA and percent free PSA alone. phi values are associated with an increased probability of prostate cancer, and with more aggressive disease. phi can also help differentiate prostate cancer from benign conditions and possibly reduce 26% of unnecessary biopsies for men with elevated PSA levels between 4.0 – 10 ng/mL.

Urine-Based Tests

• SelectMDx — SelectMDx is a urine-based, molecular test that offers a non-invasive, ‘liquid biopsy’ method to identify a patient’s risk for prostate cancer, helping to both reduce unnecessary prostate biopsy procedures with their concomitant complications and expenses, and to identify those men at increased risk of harboring high-grade disease who may benefit most from earlier detection.
• ExoDx Prostate (IntelliScore) — ExoDx Prostate (IntelliScore) is a simple urine test that detects three important genetic biomarkers that can identify the aggressiveness of prostate cancer. Using this assessment, your physician can determine whether or not you should undergo an initial biopsy or continue to be monitored for disease progression.

Tissue-Based Tests

• Oncotype DX — The Oncotype DX test is performed on the tissue sample previously obtained from your most recent biopsy and gives you an individualized result called a Genomic Prostate Score (GPS). The GPS has been shown to predict the likelihood, or the odds, that a patient’s prostate cancer will grow and spread. The information provided by the Oncotype DX prostate cancer test can help you and your doctor determine the most appropriate treatment options for you based on the biology of your individual cancer.
• Prolaris — Prolaris is a prognostic test which directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients. The 46-gene expression signature includes cell cycle progression genes selected based upon correlation with prostate tumor cell proliferation. Low gene expression is associated with a low risk of disease progression and high gene expression associated with disease progression.
• Decipher Prostate Biopsy — Decipher Prostate Biopsy test is performed on prostate biopsies samples diagnosed as positive for cancer. The test may help determine which men may be suitable candidates for active surveillance, which may need local therapy, and which men may need intensified therapy.
• ConfirmMDx — ConfirmMDx for prostate cancer is an epigenetic test that was developed and validated to rule out the presence of undetected cancer in men with benign prostate biopsy results. The assay detects epigenetic field effect associated with the “cancerization” process. This field effect around the cancer lesion can be present despite the normal histologic appearance of cells. Detection of the “halo” extends the coverage of biopsy helping rule in/rule out occult cancers.