New Accurate Epigenetic Test Could Negate Need for Repeat Biopsies of Prostate Cancer

New Accurate Epigenetic Test Could Negate Need for Repeat Biopsies of Prostate Cancer

9754In the United States each year, there are more than one million biopsies performed of the prostate. In many cases, it isn’t a single biopsy being performed per patient, as there are many instances where the same patient is forced to undergo multiple biopsies because there is fear that the cancerous cells are missed the first time. This is a problem that researchers, doctors, and patients have known about for years, but that actual test hasn’t been created yet. At least not until two recent independent clinical trials were conducted that might have the answer to this issue.

An epigenetic test that could make it easier for physicians to eliminate any need for a second or third biopsy has been validated by these two trials. The information was published in The Journal of Urology and the results will bring on a sigh of relief to any patient already going through the stress of being diagnosed with cancer.

The Study

In previous years, there were other trials conducted to test the validity of these tests. In this previous trials, there was a negative predictive value of 90 percent. These numbers came from the multiple tests performed including APC, RASSF1, and GSTP1. The latter is a specific biomarker for prostate cancer that is found in 90 percent of prostate cancer cases. APC and RASSF1 are also important field effect markers that increase the sensitivity of the assay.

There was a second multicenter study performed called DOCUMENT (Detection Of Cancer Using Methylated Events in Negative Tissue). The test validated the performance of the previous study and the epigenetic assay used in MATLOC (Methylation Analysis To Locate Occult Cancer) trial.In the DOCUMENT study, patients with prostate cancer that had a negative biopsy were evaluated so it could be determined who would be at low risk for containing in cancer that would have been missed. Researchers used biopsy sampling error to determine what patients could forego a second and unnecessary biopsy. Researchers were proud to announce that there was a 88 percent negative predictive value validated in the testing.

Alan W. Partin, MD, PhD, of the James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland spoke about the study and its findings. “T his epigenetic assay is a significant, independent predictor and has been shown to be the most valuable diagnostic aid of all evaluated risk factors in two independent trials.” He added that “negative findings of this assay could be used to reduce concern over unsampled cancer and effectively avoid unnecessary repeat biopsies.

In the first trial, DOCUMENT, there were 350 patients enrolled from five dispersed areas. The patients that were enrolled came from the Cleveland Clinic, Eastern Virginia Medical School, Lahey Hospital & Medical Center, Johns Hopkins University, and University of California Los Angeles. The control of the tests conducted were the patients that had two consecutive negative biopsies, as well as a group with patients that had a negative biopsy, followed by a positive biopsy within 24 months of each other. Each patient was given a biopsy on average of one year after the initial test for the trial.

To be included in the study, the only biopsies that could be accepted were those that had a minimum of eight cores per biopsy. They also could not be collected before 2007 and initial biopsies that contained suspicious cells were excluded from the trial as these subjects and tests would have led to a repeat biopsy based on histopathology.

What This Means to Me

Essentially what it all comes down to is with the proven success of these trials, patients that have a negative biopsy could avoid the need to suffer through the uncomfortable procedure again. For those that are afraid of hospitals and doctors, this is the best news possible. With time, these test results will be evaluated again and re-tested to prove the validity, but for the time being, this means only positive things for everyone involved.

While this trial was conducted on men and the prostate, these results could also play a large role in preventing unnecessary biopsies on woman in the future. More specific tests linking these results to women and their health will need to be conducted before this can be said for sure, but as we just said, this is only good news with a potential for great news.

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