Plenary: Next Frontier, Monday

Plenary: Next Frontier

PNFLBA-15: Late-Breaking Abstract - Interim Results of a Novel ‘Adaptive’ Registration-Utility Trial Assessing the Performance of Exodx® (Prostate) Intelliscore (EPI); a Non-DRE Urine Exosome Gene Expression Assay to Predict High Grade Disease on Initial Biopsy

Monday, May 15
11:05 AM - 11:10 AM
Location: BCEC: Ballroom East

Presentation Authors: Alan Partin*, Baltimore, MD, Phillipp Torkler, Mikkel Noerholm, Martinsried, Germany, Johan Skog, Cambridge, MA, Michael Donovan, NYC, NY

Introduction: Overdetection and overtreatment of indolent prostate cancer (PCa) remains a significant health issue requiring noninvasive assays to guide the prostate biopsy decision process. We previously demonstrated that a non-DRE urine exosome gene expression assay (ExoDx Prostate (IntelliScore) (EPI) discriminates GS 7 PCa from GS 6 and benign disease, potentially reducing the number of unnecessary biopsies. We initiated a novel prospective, phase-adaptive two cohort trial design: Group 1 (G1), men scheduled for a biopsy and Group 2 (G2), men for which the decision to biopsy is uncertain. The G1 consensus results including EPI cut-point recommendation will be applied to G2 patients with clinical utility, ease of adoption, patient response and health economic data collected. Here we report interim results from G1 with initial cut-point comparison to the original validation trial.



Methods: The trial was activated on Sept. 2016 at 9 sites (8 community practice, 1 academic), geographically distributed across the U.S. We plan to enlist up to 20 sites by April 2017. Enrollment is limited to initial biopsy patients only, >/=50 years with PSA 2-10 ng/mL. The EPI test is performed at Exosome Diagnostics’ CLIA laboratory in Cambridge, MA; G1 results are collected for consensus review and G2 recommendation.

Results: The average biopsy rate across all sites is 1-2 / week. Demographics of the 96 (of targeted) 500 G1 patients enrolled thus far are comparable to the validation study (mean age 64 years, mean PSA 5.78; 75% white, 17% African American, 23% positive family history of PCa, 81% non-suspicious DRE). Of note, we have observed a higher positive biopsy rate of 59% (vs. 47% in validation study); 22% ISUP 1 (GS 3+3) and 37% >/=ISUP 2. The EPI test validated (15.6) vs. adjusted (20) cut-points both result in NPV 90, with sensitivity of 94% and 92%, respectively. The number of avoided biopsies is greater (30%) with the adjusted cut-point of 20 vs. the original validated cut-point (21%); while missing only 1>/=ISUP 3 case. The original validated cut-point would have avoided biopsies in 30% of men with GS6 or benign disease while the adjusted cut-point would have avoided 43% of biopsies in this population.

Conclusions: Interim results from a prospective adaptive trial of the EPI test demonstrate consistent performance as identified in the original validation study. The adjusted cut-point continues to provide added benefit without risk of missing significant disease.

Source Of Funding: Private

James M. McKiernan, MD

Columbia University

James McKiernan, MD is the John K. Lattimer Professor and Chairman of the Department of Urology of the College of Physicians and Surgeons and urologist-in-chief at New York-Presbyterian/Columbia. The Department of Urology at Columbia is currently ranked 5th in NIH research funding in America and NewYork-Presbyterian’s urology program ranked No. 6 in the latest U.S. News & World Report ranking of America’s best hospitals. Dr. McKiernan graduated from Johns Hopkins University with a BA in biology and received his MD from Columbia University College of Physicians and Surgeons. He completed his training in urology and general surgery at Columbia Presbyterian, followed by a urologic surgical oncology fellowship at Memorial Sloan-Kettering Cancer Center. Dr. McKiernan specializes in urologic oncology, particularly surgical therapy in high-risk patients with bladder and kidney cancers. His research focuses on developing novel therapeutics for bladder cancer treatment as well as comparative effectiveness research in urologic oncology. In addition, Dr. McKiernan is the principal investigator of the NIH-funded clinical trials program of experimental therapeutics in bladder cancer at Columbia, which is investigating new agents for bladder preservation in patients whose cancer has recurred after standard therapy. In collaboration with researchers at Columbia’s Herbert Irving Comprehensive Cancer Center, his team continues to develop novel translational therapeutic strategies for treating bladder cancer.
Dr. McKiernan’s research has been published in Cancer, Cancer Research, the Journal of Clinical Oncology, JAMA Oncology, Journal of Urology, Urologic Oncology, and Urology. He has authored and co-authored more than 200 scientific articles and book chapters on urologic oncology.
He has served as the Vice Chairman for the AJCC TNM Staging Task Force, Vice-Chair of the AUA Guidelines Panel on non-muscle invasive bladder cancer, as well as on the American Board of Urology and Society of Urologic Oncology Examination Committees.

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PNFLBA-15: Late-Breaking Abstract - Interim Results of a Novel ‘Adaptive’ Registration-Utility Trial Assessing the Performance of Exodx® (Prostate) Intelliscore (EPI); a Non-DRE Urine Exosome Gene Expression Assay to Predict High Grade Disease on Initial Biopsy



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