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).
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 a 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.
Complete AUA 2018 Coverage