Results confirmed by two independent trials, report researchers in the Journal of Urology
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%.
"This 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," comments Alan W. Partin, MD, PhD, of the James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland. "Negative findings of this assay could be used to reduce concern over unsampled cancer and effectively avoid unnecessary repeat biopsies."
A total of 350 patients were enrolled in the DOCUMENT trial from five geographically dispersed medical centers: Cleveland Clinic, Eastern Virginia Medical School, Lahey Hospital & Medical Center, Johns Hopkins University, and University of California Los Angeles. Patients were grouped into those with two consecutive negative biopsies (controls) and those with a negative biopsy followed by a positive biopsy within 24 months. The initial archived, negative for cancer, prostate biopsy core tissue samples were evaluated. All of the men underwent a repeat biopsy on average one year after the initial biopsy.
Only biopsies with a minimum of eight cores per biopsy, collected no earlier than 2007, were included in the study, while initial biopsies with atypical cells suspicious for cancer, i.e. atypical small acinar proliferation by the sites' pathologists, were excluded, since this would have triggered a repeat biopsy based upon histopathology alone.
After correcting for age, prostate specific antigen (PSA), digital rectal exam, histopathological characteristics of the first biopsy, and race, this epigenetic test proved to be the most significant, independent, and strongest predictor of patient outcome with an odds ratio of 2.69 as well as the most valuable diagnostic aid of all evaluated risk factors. The slightly decreased sensitivity of the DOCUMENT trial compared to the MATLOC trial is most likely associated with a higher PSA screening prevalence in the DOCUMENT cohort.
Linda Gruner | Eurek Alert!
Millions through license revenues
27.04.2017 | Rheinische Friedrich-Wilhelms-Universität Bonn
New High-Performance Center Translational Medical Engineering
26.04.2017 | Fraunhofer ITEM
More and more automobile companies are focusing on body parts made of carbon fiber reinforced plastics (CFRP). However, manufacturing and repair costs must be further reduced in order to make CFRP more economical in use. Together with the Volkswagen AG and five other partners in the project HolQueSt 3D, the Laser Zentrum Hannover e.V. (LZH) has developed laser processes for the automatic trimming, drilling and repair of three-dimensional components.
Automated manufacturing processes are the basis for ultimately establishing the series production of CFRP components. In the project HolQueSt 3D, the LZH has...
Reflecting the structure of composites found in nature and the ancient world, researchers at the University of Illinois at Urbana-Champaign have synthesized thin carbon nanotube (CNT) textiles that exhibit both high electrical conductivity and a level of toughness that is about fifty times higher than copper films, currently used in electronics.
"The structural robustness of thin metal films has significant importance for the reliable operation of smart skin and flexible electronics including...
The nearby, giant radio galaxy M87 hosts a supermassive black hole (BH) and is well-known for its bright jet dominating the spectrum over ten orders of magnitude in frequency. Due to its proximity, jet prominence, and the large black hole mass, M87 is the best laboratory for investigating the formation, acceleration, and collimation of relativistic jets. A research team led by Silke Britzen from the Max Planck Institute for Radio Astronomy in Bonn, Germany, has found strong indication for turbulent processes connecting the accretion disk and the jet of that galaxy providing insights into the longstanding problem of the origin of astrophysical jets.
Supermassive black holes form some of the most enigmatic phenomena in astrophysics. Their enormous energy output is supposed to be generated by the...
The probability to find a certain number of photons inside a laser pulse usually corresponds to a classical distribution of independent events, the so-called...
Microprocessors based on atomically thin materials hold the promise of the evolution of traditional processors as well as new applications in the field of flexible electronics. Now, a TU Wien research team led by Thomas Müller has made a breakthrough in this field as part of an ongoing research project.
Two-dimensional materials, or 2D materials for short, are extremely versatile, although – or often more precisely because – they are made up of just one or a...
28.04.2017 | Event News
20.04.2017 | Event News
18.04.2017 | Event News
28.04.2017 | Medical Engineering
28.04.2017 | Earth Sciences
28.04.2017 | Life Sciences