Cleveland Clinic-led Study Finds that More than 40 Percent of Prostate Biopsies Could Have Been Avoided with New Blood Test

Findings to be presented during 2018 Annual Meeting of the American Urological Association

San Francisco: A multi-center study that validates the clinical performance of IsoPSA – a new blood test that has proven to be more accurate in predicting overall risk of prostate cancer than standard prostate-specific antigen (PSA) – will be presented during a special press conference at the 13th Annual Meeting of the American Urological Association (AUA) on May 18 in San Francisco.

Results showed that more than 40 percent of biopsies could have been avoided in both the preliminary study (45.1 percent) and validation study (47 percent), suggesting that use of IsoPSA may substantially reduce the need for biopsy, and may thus lower the likelihood of overdetection and overtreatment of nonlethal prostate cancer.

The study, Prospective Validation of the IsoPSATM Assay for Detection of High Grade Prostate Cancer, was conducted as a follow-up to early studies which demonstrated that IsoPSA, a structure-focused protein biomarker, may be an effective means of discriminating between high-grade prostate cancer (Gleason≥7) and low-grade/benign disease (Gleason=6).

Eric Klein, M.D., chair, Glickman Urological & Kidney Institute

The research team, led by Cleveland Clinic’s Eric Klein, M.D., conducted a multicenter validation trial and evaluated performance data with a new cohort, including cutoff parameters derived from a preliminary study, using the detection of cancer by biopsy as the endpoint.

“To be clinically useful, a biomarker must be both tissue-specific and cancer-specific. While PSA is prostate-specific, it is not specific for prostate cancer, leading to diagnostic inaccuracy and too many unneeded biopsies,” said Dr. Klein, chair of Cleveland Clinic’s Glickman Urological & Kidney Institute. “IsoPSA fulfills both the tissue- and cancer-specificity needed for a useful biomarker, and this validation study shows that it can more accurately detect high-grade cancer and reduce the rate of unneeded biopsies in patients at low risk of this disease.”

The IsoPSA test was developed by Cleveland Diagnostics, a company co-founded by Cleveland Clinic, in which it has financial interest. Dr. Klein has no personal financial interest in the company. Mark Stovsky. M.D., a Cleveland Clinic urologist and co-author on the study, has a leadership position (Chief Medical Officer) and investment interest in Cleveland Diagnostics. In late 2017, Cleveland Diagnostics and Genomic Health announced an exclusive licensing agreement to develop and commercialize the IsoPSA test.

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About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Among Cleveland Clinic’s 52,000 employees are more than 3,600 full-time salaried physicians and researchers and 14,000 nurses, representing 140 medical specialties and subspecialties. Cleveland Clinic’s health system includes a 165-acre main campus near downtown Cleveland, 11 regional hospitals, more than 150 northern Ohio outpatient locations – including 18 full-service family health centers and three health and wellness centers – and locations in Weston, Fla.; Las Vegas, Nev.; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2017, there were 7.6 million outpatient visits, 229,000 hospital admissions and 207,000 surgical cases throughout Cleveland Clinic’s health system. Patients came for treatment from every state and 185 countries. Visit us at clevelandclinic.org. Follow us at twitter.com/ClevelandClinic. News and resources available at newsroom.clevelandclinic.org.

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