Prostate cancer tests guide treatment, identify aggressive disease

Results from the novel prostate cancer prognostic test Prolaris (Myriad Genetics, Salt Lake City, UT) are associated with modified treatment decisions for patients with the disease.

Interim data from PROCEDE 500, a clinical utility study of the test, were presented at the Genitourinary Cancers Symposium in San Francisco.

In a separate presentation at the meeting, researchers reported that another test, ConfirmMDx for Prostate Cancer (MDxHealth, Irvine, CA), may help urologists make more informed treatment decisions in men with Gleason 6 prostate cancer.

PROCEDE 500 is an ongoing prospective registry study designed to examine the clinical utility of Prolaris. Currently, 331 patients have been enrolled and 150 clinicians have completed surveys in 305 cases to assess the influence of the Prolaris score on clinical decision making.

Results from interim data show that in 65% of cases, physicians changed their intended therapy and selected a different treatment based on the Prolaris test score. In 40% of patients, physicians reduced the therapeutic burden on patients and opted for conservative management options such as active surveillance and watchful waiting. In 25% of cases, physicians increased treatments including the use of surgery or radiation, and in 35% of cases, physicians did not change their treatment plans. Full results from PROCEDE 500 have been submitted to a peer-reviewed journal for publication.

Research on Prolaris was also recently presented at the 2013 Society of Urologic Oncology meeting in Bethesda, MD.

"Prolaris has opened the door to a new era of personalized cancer treatment for men with prostate cancer. The Prolaris score is a stronger predictor of prostate cancer death and recurrence than either Gleason score or PSA, and delivers clinically relevant information not provided by any other prognostic test,” said Michael Brawer, MD, of Myriad Genetics.

Continue to next page for coverage of ConfirmMDx.

In the ConfirmMDx study, data confirmed that epigenetic profiling of selected genes provides prognostic information, corresponding to Gleason score (GS), that could help identify patients with aggressive prostate cancer.

“Men diagnosed with GS6 cancer may be eligible for active surveillance. However, today’s standard 12-core TRUS (transrectal ultrasound)-guided biopsies are susceptible to under-sampling, leaving men at risk for undetected aggressive disease. These promising data demonstrate that epigenetic testing is not only valuable for the decision on repeat biopsy, but may also yield important prognostic information that could help us identify men who are at low risk for aggressive disease,” noted senior author E. David Crawford, MD, of the University of Colorado Denver School of Medicine, Aurora.

In this study, the prognostic value of the epigenetic status of five genes (GSTP1, APC, RASSF1, RARB, and LGALS3) in 84 prostatectomy samples with different Gleason scores was evaluated. The results of a hierarchical clustering analysis showed that low gene methylation levels were detected in the vast majority of patient samples with GS6 and GS7 (3+4) prostate cancer. In contrast, respectively 81% and 91% of the GS7 (4+3) and GS ≥8 samples fell into the category with intermediate to high methylation levels. These data provide evidence of the potential prognostic value of the epigenetic profile of selected genes to identify men with a low versus high risk for aggressive prostate cancer.

Dr. Crawford has received research funding and honoraria from MDxHealth.

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