Prognostic Biomarker Tests for Prostate Cancer

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Biomarker tests can be a useful addition to a prostate specific antigen (PSA) screening for determining who needs an initial biopsy, the appropriateness of a repeat biopsy, and whether a person may be a candidate for active surveillance, suggests Neal D. Shore, MD. It is important for oncologists to be judicious about their treatment recommendations, and genomic assays can help with these decisions.

The widespread use of the PSA screening test has become somewhat controversial. However, despite the advancements in the development of biomarker tests, there is no single biomarker assay that is accurate enough to replace the PSA test, according to Philippa J. Cheetham, MD. More than likely, multiple biomarker tests will be used in conjunction with the PSA test to help physicians avoid unnecessary biopsies and overtreatment. Biopsies are invasive procedures that carry the risk of infection. For many patients, Cheetham prefers to use magnetic resonance imaging to look for lesions.

The rate of biomarker discovery seems to be outpacing the research that can be conducted on them, says Michael E. Williams, MD. Some of the available biomarker tests include the 4Kscore, the Mi-prostate score, and the Prostate Health Index. Williams notes that more simple tools exist that can also help predict the risk of prostate cancer, such as a web-based risk calculator based on data from the Prostate Cancer Prevention Trial. Cheetham adds that it is important to understand the sensitivity and specificity of the available tests before using them.

Fortunately, there has been more scientific vetting of the tests than in the past, notes Shore. Rather than simply using validation studies, companies are expected to conduct prospective clinical utility trials. Having this type of data will be essential for a test to qualify for reimbursement, he notes.