Getting Off Biopsy Train in Prostate Cancer


Freddie Hamdy, MBChB, a leading prostate cancer researcher and head of urology at University of Oxford, blew my mind when I spoke with him the other day.

“He told me we are on the cusp of a revolution in active surveillance (AS) for prostate cancer — one that will in effect ‘cure’ my cancer with a swipe of a pen as cancer will be redefined.

“A prostate cancer diagnosis with a low-risk Gleason 6 changed my life in December 2010. My first urologist offered to rush me to the OR. I declined and got a second opinion. Instead, I opted for AS and have been on it ever since.”

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Active Surveillance of Prostate Cancer Associated with Favorable Outcomes in Younger Men


“Younger age was associated with lower risks for disease progression and biopsy-based Gleason score upgrades during active surveillance of low- or intermediate-risk prostate cancer, according to a study published in Journal of Clinical Oncology.

” ‘The results of this study indicate that younger patients with low-risk prostate cancer experienced favorable outcomes when managed with active surveillance at nearly 5-year median follow-up,’ Michael Leapman, MD, assistant professor in the department of urology at Yale University School of Medicine, told HemOnc Today. ‘Younger patients have conventionally been counseled to receive definitive treatment, even in the setting of low-risk disease. This study is impactful as it may expand the use of surveillance, potentially limiting the harms of overtreatment for patients with screening-detected low-grade tumors.’ ”

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Prostate Cancer Surveillance Criteria May Not Be Accurate for African American Men

“A new study published in The Journal of Urology revealed that African American men with Gleason score 3+3=6 prostate cancer (PCa) produce less prostate specific antigen (PSA) and have significantly lower PSA density (PSAD) than Caucasian men. These findings could have important implications when selecting patients for inclusion in active PCa surveillance programs.

“Prostate cancer remains the second leading cause of  among  in the U.S., with nearly 30,000 deaths annually. According to the latest recommendations by the American Urological Association, PSA remains the only screening test to select men with unremarkable digital rectal examination in whom prostate biopsy should be considered. Deaths from  have declined by about 40% since the advent of PSA screening in the late 1980s, and 40-70% of that decline may be attributable to screening. For early stage low grade disease, active surveillance, commonly called watchful waiting, is considered appropriate.”

MDxHealth's ConfirmMDx Genes Identify Prostate Cancer Aggressiveness in Diagnostic Biopsies

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.’ “

Test Spares Men Unnecessary Biopsies for Prostate Cancer

Editor’s note: Some men must undergo more than one biopsy to accurately diagnose prostate cancer and assess its severity. Now, a test called ConfirmMDx can be used on tumor tissue from an initial biopsy to get a more detailed picture of a patient’s condition, reducing the likelihood that an extra biopsy will be needed. New studies show that the test could “lead to a 10-fold reduction in repeat biopsies.”

“In men with previous histopathologically negative findings, the epigenetic ConfirmMDx (MDxHealth) assay for prostate cancer can lead to a 10-fold reduction in repeat biopsies, 2 new studies show.

“Both confirm the utility of epigenetic profiling in helping to distinguish patients who have a true negative biopsy from those at risk for occult cancer, according to the researchers.

“The commercially available assay assesses methylation markers of prostate cancer (GSTP1APC, and RASSF1) to distinguish histologically benign biopsy cores from patients diagnosed with no cancer, low-volume cancer (a Gleason score of 6), or higher-volume cancer (a Gleason score of 7).

“One of the studies, a clinical utility field study in which the assay was tested by practicing urologists working in community settings, was published in the May issue of American Health & Drug Benefits.

Chronic Inflammation Linked to 'High-Grade' Prostate Cancer

“Men who show signs of chronic inflammation in non-cancerous prostate tissue may have nearly twice the risk of actually having prostate cancer than those with no inflammation, according to results of a new study. The link between persistent inflammation and cancer was even stronger for men with so-called high-grade prostate cancer — those with a Gleason score between 7 and 10 — indicating the presence of the most aggressive and rapidly growing prostate cancers.”

Myriad's Prolaris(R) Test Significantly Modifies Treatment Decisions for Patients With Prostate Cancer

“Myriad Genetics, Inc. (MYGN) today announced results from PROCEDE 500, a clinical utility study with its Prolaris test, at the 2014 ASCO Genitourinary Cancers Symposium in San Francisco, Calif. The study demonstrated the significant clinical value of Prolaris to physicians who are treating men with prostate cancer. Prolaris is a prognostic test that accurately predicts prostate cancer-specific death and metastases and has been validated in 11 clinical studies with more than 5,000 patients.

” ‘Prolaris has opened the door to a new era of personalized cancer treatment for men with prostate cancer,’ said Michael Brawer, M.D. vice president of medical affairs at Myriad Genetic Laboratories. ‘The Prolaris score is a stronger predictor of prostate cancer death and recurrence than either Gleason score or PSA (prostate specific antigen), and delivers clinically relevant information not provided by any other prognostic test.’ “

Added Prostate CA Criteria May Help ID Surveillance Candidates

“Additional predictors, such as prostate-specific antigen (PSA) density and extent of cancer on biopsy, help guide selection of prostate cancer patients for active surveillance programs, according to research published in the February issue ofThe Journal of UrologyIn an effort to identify predictors of adverse pathology, Annelies Vellekoop, M.D., of New York University in New York City, and colleagues analyzed data for 4,500 men who underwent radical prostatectomy for Gleason 6 prostate cancer. The researchers included a subset with extended biopsy data.”

Nomogram Aims to Enable Informed Decision-Making and Personalized Treatment for Prostate Cancer

“Studies have found that prostate cancer is overdiagnosed in up to 42 percent of cases, prompting men to receive unnecessary treatment that can cause devastating side effects, including impotence and incontinenceNow, researchers at Fred Hutchinson Cancer Research Center and the University of Washington have developed a personalized tool that can predict the likelihood of prostate cancer overdiagnosis. They announced their findings in the online issue of the Journal of the National Cancer Institute.”