“Among a group of men with an initial negative prostate biopsy, clinically significant cancer is still found in subsequent repeat sampling rounds, according to a study published in the April issue of The Journal of Urology.
“Nitya E. Abraham, M.D., from the New York University School of Medicine in New York City, and colleagues collected data on 1,837 men who underwent prostate biopsy (Jan. 1, 1995, to Jan. 1, 2010). The authors sought to determine characteristics of repeat biopsy (indication for biopsy, the number of repeat biopsies performed, the number of cores obtained, and total prostate-specific antigen before biopsy), as well as features of prostate cancer diagnosed on repeat biopsy (including Gleason score, number of positive cores, percent of tumor and treatment choice).
“The researchers found that 1,213 men had negative initial biopsies, but that 798 repeat biopsies were performed in 255 men. Gleason score was ≤6 in 33 of 63 men diagnosed with prostate cancer, 7 in 22, and 8 to 9 in eight. Using Epstein criteria, the rate of clinically insignificant cancer diagnosis decreased substantially by the third and fourth repeat biopsies. An increased likelihood of prostate cancer diagnosis was seen in men ≥70 years with repeat biopsies, biopsies including more than 20 cores, and the fourth repeat biopsy.”
“Thomas Lynch, MD, has been a leader in the development of numerous novel therapies for the treatment of lung cancer. His significant contributions to the field have earned him great recognition, including the 2013 Giants of Cancer CareTM award in Lung Cancer for his pioneering use of molecular testing for EGFR mutations.
“Lynch, who is director of the Yale Cancer Center and physician-in-chief at the Smilow Cancer Hospital at Yale-New Haven, recently sat down with OncLive and discussed key strategies and trends in the management of lung cancer. In a wide-ranging interview, Lynch provides expert insight across the spectrum of care, from screening to the challenges associated with resistance mutations.”
“The use of a prostate cancer antigen 3 (PCA3) urine test could help men avoid undergoing unnecessary repeat biopsies, and could help physicians predict which men undergoing initial biopsy will be positive for cancer.
“John T. Wei, MD, of the University of Michigan, and colleagues published the results of the National Cancer Institute Early Detection Research Network validation of PCA3 trial in the Journal of Clinical Oncology.
“According to Wei, how physicians decide to send a patient for prostate biopsy is continuing to evolve. Although in the past, an abnormal PSA test resulted in an order for a biopsy, the discovery and validation of new biomarkers is changing that precedent.
“ ‘Prostate cancer tests such as the PCA3, an FDA approved, commercially available urine assay for prostate cancer, are allowing doctors to more accurately determine if a man has prostate cancer prior to a biopsy,’ Wei told Cancer Network. ‘Based on our findings, using PCA3, many fewer men will need to undergo a repeat prostate biopsy. On the other hand, PCA3 may also indicate an elevated risk of prostate cancer in other men, prompting them to undergo a prostate biopsy when its needed.’
“In the study, Wei and colleagues evaluated 859 men scheduled for diagnostic prostate biopsy between 2009 and 2011. The researchers evaluated whether the PCA3 urine test had a high positive predictive value at initial biopsy and a high negative predictive value at repeat biopsy.”
The gist: Earlier this year, we posted about a new test that could reduce the need for multiple biopsies to accurately diagnose men with prostate cancer. Now, the company that makes the test, called ConfirmMDx, reports that the results of the test for a given patient strongly correlate with already-established measurements, such as Gleason Score (GS). This supports the use of the test to help diagnose and determine the severity of prostate cancer.
“MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today announced positive data from an important study confirming the ability of the ConfirmMDx® genes to identify prostate cancer (PCa) aggressiveness in diagnostic biopsies. The data, presented at the European Association of Urology, Section Urological Research (ESUR) meeting in Glasgow, UK (October 9-11, 2014), confirmed that the epigenetic profile of ConfirmMDx genes generated by the test is strongly correlated with established risk stratification metrics, such as Gleason Score (GS) and the NCCN (National Comprehensive Cancer Network) risk categories.
” ‘These data demonstrate that ConfirmMDx for Prostate Cancer not only provides important diagnostic information to help guide the decision on repeat biopsy, but that the genes may also deliver significant prognostic value, potentially determining whether a man has an aggressive or non-aggressive form of prostate cancer,’ noted Sandra M. Gaston PhD, Director of Urological Research at New England Baptist Hospital and Director of the Molecular Biomarkers Research Laboratory in the Department of Pathology and Laboratory Medicine at Tufts Medical Center in Boston Massachusetts. ‘This study suggests that the epigenetic markers used in the ConfirmMDx test could have an expanded role in stratifying prostate biopsy patients by providing information that cannot be obtained from the histological examination of the tissue. The current ConfirmMDx test is highly sensitive for DNA hypermethylation of GSTP1, APC and RASSF1 in the tissue surrounding a prostate cancer. For men who have a histological diagnosis of “no cancer,” a negative result with the current ConfirmMDx test predicts that a subsequent biopsy will also be negative, identifying the majority of men who may avoid repeat biopsy. In this study, we found that hypermethylation of these markers is more intense in the tissue surrounding high grade prostate cancer potentially providing additional insights into the clinical significance of a potential undetected prostate cancer on methylation-positive patients.’ “
“More than one million prostate biopsies are performed each year in the U.S. alone, including many repeat biopsies for fear of cancer missed. Therefore there is a need to develop diagnostic tests that will help avoid unnecessary repeat biopsies. Two independent trials have now validated the performance of an epigenetic test that could provide physicians with a better tool to help eliminate unnecessary repeat prostate biopsies, report investigators in The Journal of Urology.
“In the previously reported independent MATLOC (Methylation Analysis To Locate Occult Cancer) trial, a multiplex epigenetic assay (ConfirmMDx for Prostate Cancer) profiling the APC, GSTP1 and RASSF1 genes demonstrated a negative predictive value of 90%. GSTP1 methylation is a specific biomarker for (prostate) cancer and this gene is methylated in up to 90% of prostate cancer cases. Additionally, APC and RASSF1 are important field effect markers and increase the diagnostic sensitivity of the assay.
“A second multicenter study, DOCUMENT (Detection Of Cancer Using Methylated Events in Negative Tissue), has validated the performance of the epigenetic assay used in the MATLOC trial as an independent predictor of prostate cancer risk to guide decision making for repeat biopsy. In the DOCUMENT study patients with a negative biopsy were evaluated to identify those at low risk for harboring cancer missed, through biopsy sampling error, who could forego an unnecessary repeat biopsy. The validation study resulted in a negative predictive value of 88%.”