Mp72-04 association of clinical trial enrollment and mortality amongst patients with advanced prostate cancer

You have accessJournal of UrologyCME1 Apr 2023MP72-04 ASSOCIATION OF CLINICAL TRIAL ENROLLMENT AND MORTALITY AMONGST PATIENTS WITH ADVANCED PROSTATE CANCER Rodrigo R Pessoa, Thomas Flaig, Tyler Robin, BORIS Gershman, Michael Bronsert, Kayvon Kiani, Eric Ballon-Landa, Corbin Eule, Elizabeth Kessler, Marc C Smaldone, and Simon P Kim Rodrigo R PessoaRodrigo R Pessoa More articles by this author , Thomas FlaigThomas Flaig More articles by this author , Tyler RobinTyler Robin More articles by this author , BORIS GershmanBORIS Gershman More articles by this author , Michael BronsertMichael Bronsert More articles by this author , Kayvon KianiKayvon Kiani More articles by this author , Eric Ballon-LandaEric Ballon-Landa More articles by this author , Corbin EuleCorbin Eule More articles by this author , Elizabeth KesslerElizabeth Kessler More articles by this author , Marc C SmaldoneMarc C Smaldone More articles by this author , and Simon P KimSimon P Kim More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003340.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Publication bias has been raised as concern in reporting clinical trials with negative results. However, little is known about the degree of publication bias from clinical trials with negative results for prostate cancer. Thus, we sought to elucidate the association of enrollment into a clinical trial and all-cause mortality from a population-based cohort of men with advanced prostate cancer in the U.S. METHODS: From CancerLinQ, a large national database of community oncology practices, all men with N1 and/or M1 advanced prostate cancer were identified from 2011 to 2021. The primary outcome was all-cause mortality. Multivariable Cox Proportional Hazards were used to test the association of overall survival and clinical covariates including clinical trial enrollment. RESULTS: During the study interval, we identified 139,971 men diagnosed with advanced prostate cancer. With a median follow-up of 58 months, only 2.3% of patients were enrolled into a clinical trial (n=3,269). On multivariable analysis adjusting for disease features, Asian (HR: 0.61; p<0.001) race and Hispanic/Latino origin (HR: 0.68; p<0.001) were associated with lower risk of all-cause mortality. Higher ECOG performance status also correlated with higher risk of all-cause mortality (all p<0.001). However, patients enrolled into clinical trials had higher risk of all-cause mortality compared to those patients who were not enrolled (HR: 1.18; p<0.001). CONCLUSIONS: In this population-based cohort of advanced prostate cancer patients, clinical trial enrollment was associated with a higher risk of all-cause mortality. We controlled for pertinent prognostic variables, but it remains possible that poorer prognosis patients are triaged to clinical trials. However, an alternate explanation is that some trials do have worse outcomes than standard of care and these findings raise concern that negative clinical trial results are rarely disseminated. Source of Funding: Schramm Foundation © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1025 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Rodrigo R Pessoa More articles by this author Thomas Flaig More articles by this author Tyler Robin More articles by this author BORIS Gershman More articles by this author Michael Bronsert More articles by this author Kayvon Kiani More articles by this author Eric Ballon-Landa More articles by this author Corbin Eule More articles by this author Elizabeth Kessler More articles by this author Marc C Smaldone More articles by this author Simon P Kim More articles by this author Expand All Advertisement PDF downloadLoading ...