Robert L. Waterhouse Jr, MD, MBA
A new test that can detect the existence of tumor activity is gaining credibility as a means of confirming the results of prostate biopsies, which have the potential to miss tumor cells. The ConfirmMDx epigenetic assay from MDxHealth, of Belgium, hunts for signs of DNA methylation, and recent study results have confirmed its value. One study in particular, involving African American men, was presented in May at the American Urological Association (AUA) annual meeting and demonstrated strong negative predictive value.1
Although the biopsy is targeted for areas of most probable activity, it can still amount to a proverbial shot in the dark. “We’re sampling less than 1% of the prostate, so when we look at the men who are undergoing biopsies, most urologists would argue that there is a chance the biopsy might have missed something,” Thibodeau said.
The ConfirmMDx assay is efficient in that it can analyze the same tissue removed during a biopsy and potentially detect cancer even if tumor cells are not present in the sample. Typically, if after a prostate biopsy, a urologist still feels that the patient may be at risk for cancer—for example, based on results of a digital rectal exam or prostate-specific antigen (PSA) test—a second biopsy and perhaps even more could be performed. However, additional biopsies could compound the risk of bleeding and infection, lengthen recovery time for the patient, and cause patients to become frustrated with the process.
Improving Diagnosis in African American Men
The recent trial results showing that ConfirmMDx has predictive value among African American men suggest the potential for improved treatment in this population, which is underserved when it comes to prostate cancer diagnosis and therapy. African American males have a greater risk of clinically significant prostate cancer than the general population, and prostate cancer in this racial grouping tends to have a different molecular structure. They are approximately 1.6 times more likely than Caucasians and 2.7 times more likely than Asian Americans to develop the disease.4
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