Discovery
January 25, 2016

For the first time, a blood test is available to help men with advanced prostate cancer determine if certain medicines will work – or if they can avoid the trouble and cost of taking expensive drugs that won't fight their cancer. This test, developed and tested at Johns Hopkins, promises to predict treatment response and resistance in men with prostate cancer that no longer responds to standard hormonal therapy.

The test targets a faulty androgen receptor (AR) molecule called AR-V7, discovered in 2008 by Brady scientist Jun Luo, Ph.D. "This is a major milestone," says Luo, who also pioneered the first AR-V7 blood test in his research laboratory. "Transforming a discovery and moving a test from bench to bedside has been a major challenge historically."

That the test is available now to patients at the Brady represents several victories — of collaboration among scientists and physicians in several disciplines, and of Brady philanthropists who saw a need and responded with what urologist Patrick Walsh, M.D., calls "an emergency influx of generosity." Walsh, University Distinguished Professor of Urology, notes that "the Brady Institute itself wouldn't have been possible without private philanthropy — starting with a large endowment from James 'Diamond Jim' Brady a century ago. Time after time, friends of the Brady have stepped in and their support has made it possible for us to continue to do great things. In this case, this gift helped get the test to the men who need it most as soon as possible." The philanthropists who helped make this test available are: Alison Mass Bommarito and Salvatore J. Bommarito, R. Christian B. Evensen, A.R. Deane Nesbitt, Jr., Joseph F. Rascoff, Harvey G. Sherzer, Carolyn and William C. Stutt, F. Patrick Hughes, and John C. Corckran , Jr.

The study that led to this new AR-V7 test began about one year ago and was conducted in the Molecular Diagnostic Laboratory, led by James Eshleman, M.D., Ph.D., Professor of Pathology, in conjunction with Luo's laboratory. "We walked through every bit of detail of this test," Eshleman says, a complex process, "and carried out a complete analysis to justify using the test on men with advanced prostate cancer." The Molecular Diagnostic Laboratory at Hopkins is a CLIA-certified lab. (Any facility that performs laboratory tests on human specimens for the purpose of diagnosis or treatment is required by Federal law to have a CLIA certificate, and Medicare requires the CLIA certificate number before any claims can be processed.)

For men with advanced cancer that has become resistant to hormonal therapy, there are now six FDA-approved drugs that have been shown to improve survival. "We ultimately hope that biomarker tests such as AR-V7 will help clinicians decide among these six drugs in a more rational manner," says Emmanuel Antonarakis, M.D., Ph.D., Associate Professor of Oncology, who was the clinical lead investigator on this project. "Having a robust clinical test for measuring AR-V7 in blood is only the first step, however." Antonarakis cautions that further prospective clinical trials will be required before the AR-V7 test is clinically validated and before information from the test can be used to guide treatment decisions for all men with advanced prostate cancer. The AR-V7 blood test offered by the Molecular Diagnostic Laboratory has not yet been approved by the FDA and is available only at Johns Hopkins.

For more information on how to request this test, please contact: Katie Beierl, molecularpathresults@jhmi.edu.