Abstracts from the Mid-Atlantic Section of the AUA 2020

MA AUA 2020 Abstracts Factors Associated with Upgrading on Re-Biopsy in Active Surveillance: Data from PURC R. Talwar 1 ; K. Michel 1 ; S. Mittal 1 ; L. Xia 1 ; C. Fonshell 2 ; J. Danella 3 ; T. Lanchoney 4 ; S. Ginzburg 5 ; J. Raman 6 ; A. Reese 7 ; J. Tomaszewski 8 ; E. Trabulsi 9 ; M. Smaldone 10 ; R. Uzzo 10 ; D. Lee 1 ; T. Guzzo 1 1 UniversityofPennsylvania,PerelmanSchoolofMedicine,Philadelphia,PA,USA; 2 HealthCare ImprovementFondation,Philadelphia,PA,USA; 3 GeisingerMedicalCenter,Danville,PA,USA; 4 Urology Health Specialists, Hershey, PA, USA; 5 Einstein Healthcare Network, Philadelphia, PA, USA; 6 Penn State Milton S. Hershey Medical Center, Hershey, PA, USA; 7 Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA; 8 MD Anderson Cancer Center at Cooper University, Camden, NJ, USA; 9 Sidney Kimmel Medical College at Thomas JeffersonUniversity,Philadelphia,PA,USA; 10 FoxChaseCancerCenter,Philadelphia,PA,USA Introduction: Active surveillance (AS) is increasingly utilized for management of prostate cancer (PCa) across all demographics. The ideal AS candidate has low risk PCa that remains indolent and stable, but risk factors for grade progression are still poorly understood. Herein we studied factors associated with upgrading on re-biopsy in patients enrolled in AS. Materials & Methods: Within PURC, a prospective quality improvement collaborative of diverse academic and community urology practices in Pennsylvania &New Jersey, we identified all men enrolled inAS from 2015-2018 after first biopsy. We analyzed differences in pathologic grading between the first and second biopsy and factors associated with upgrading at the second biopsy. Results: We identified 477 patients enrolled in AS who underwent 2 biopsies from 2015-2018. 346 (72.5%) patients who underwent re-biopsy had a second positive biopsy. Higher PSA, Gleason score, number of positive cores, and family historywere associatedwithapositivesecondbiopsy(p<0.05).Whenanalyzingpathologyresults of the positive second biopsy, 243 (70%) patients had a concordant or lower grade, and 103 (29.8%) patients were upgraded. Higher Gleason score, ISUP Grade Group, number of positive cores, and positive family historywere associatedwith upgrading (p<0.05).Onregressionanalysis,nofactorswerepredictiveofupgrading.113patients had only 1 positive core on initial biopsy. These were sub classified into 2 groups, those who had < 50% or > 50% tissue involved. No differences were noted in rates of positive second biopsy or upgrading between these groups (97% vs. 92%, p = 0.18). Conclusions: Of those with a second positive biopsy, 29.8% were upgraded at their confirmatory biopsy. Higher Gleason score, International Society of Urological Pathology (ISUP) Grade Group, number of positive cores, and positive family history were all significantly associated with upgrading. These associations may be taken into consideration upon shared-decision making for PCa treatment. Clinical Utility of ExoDx Prostate in Men on Initial Biopsy R. Tutrone 1 ; J. McKiernan 2 ; M. Donovan 3 ; P. Torkler 4 ; V. Tadigotla 4 ; M. Noerholm 4 ; J. Skog 4 1 Chesapeake Urology Research Associates, Baltimore, MD, USA; 2 Columbia University Medical Center, New York, NY, USA; 3 NY Icahn School of Medicine at Mount Sinai, New York, NY, USA; 4 Exosome Diagnostics, Waltham, MA, USA Introduction: The ExoDx Prostate (EPI) test is a non- invasive risk assessment tool for detection of high-grade prostate cancer (HGPC). We sought to assess the impact of EPI on the decision to biopsy in a real-world clinical setting. Materials & Methods: We conducted a prospective, randomized, blinded, two- armed clinical utility study (N = 1094) with 72 urologists from 24 urology practices. Subjects were enrolled based on standard clinical criteria. All subjects had an EPI test; however, subjects were randomized into an EPI and control arm where only the EPI arm received the results for their biopsy decision. Results: In the EPI arm (n = 458), 93 subjects received a negative EPI score of which 63%were recommended to defer biopsy by the urologist and 74%ultimately deferred. In contrast, 87% of subjects with a positive EPI score were recommended to undergo biopsy with a 72% compliance rate to the urologist’s recommendation. This led to the detection of 18 more HGPC compared to the control arm. Due to the high deferral of biopsies that occurs in patients evaluated by standard of care (the blinded control arm), it is projected that 94 HGPC will be missed. In contrast, only 46 HGPC is projected to be missed among the deferred EPI arm patients (Figure). Overall, 68%of urologists reported that the EPI test influenced their biopsy decision. The primary reason not to comply with EPI results was a rising PSA. Conclusions: To our knowledge, this is the first report on a prostate cancer biomarker utility study with a blinded control arm. The study demonstrates that the EPI test influences the overall decision to defer or proceed with a biopsy and improves patient stratification. PDA-10 PDA-09 9 Podium Session A