PD26-10 COMPARISON OF INTRAVESICAL THERAPY AND SURGERY AS TREATMENT OPTIONS FOR RECURRENT BLADDER CANCER (CISTO): UPDATE ON AN ONGOING MULTICENTER PRAGMATIC STUDY

Abstract

You have accessJournal of UrologyCME1 May 2022PD26-10 COMPARISON OF INTRAVESICAL THERAPY AND SURGERY AS TREATMENT OPTIONS FOR RECURRENT BLADDER CANCER (CISTO): UPDATE ON AN ONGOING MULTICENTER PRAGMATIC STUDY John Gore, Erika Wolff, Bryan Comstock, Kristin Follmer, Michael Nash, On Ho, Stephanie Chisolm, Doug MacLean, Jenney Lee, Sarah Lawrence, Danielle Lavallee, Yair Lotan, Gary Steinberg, Sima Porten, Larry Kessler, Angela Smith, and CISTO Collaborative John GoreJohn Gore More articles by this author , Erika WolffErika Wolff More articles by this author , Bryan ComstockBryan Comstock More articles by this author , Kristin FollmerKristin Follmer More articles by this author , Michael NashMichael Nash More articles by this author , On HoOn Ho More articles by this author , Stephanie ChisolmStephanie Chisolm More articles by this author , Doug MacLeanDoug MacLean More articles by this author , Jenney LeeJenney Lee More articles by this author , Sarah LawrenceSarah Lawrence More articles by this author , Danielle LavalleeDanielle Lavallee More articles by this author , Yair LotanYair Lotan More articles by this author , Gary SteinbergGary Steinberg More articles by this author , Sima PortenSima Porten More articles by this author , Larry KesslerLarry Kessler More articles by this author , Angela SmithAngela Smith More articles by this author , and CISTO Collaborative More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002574.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Patients with non-muscle-invasive bladder cancer (NMIBC) that recurs after treatment with intravesical Bacillus Calmette-Guerin (BCG) must weigh the risk of progression of bladder cancer and loss of a window of potential cure with medical therapy against the risk of morbidity and loss of quality of life (QOL) with radical cystectomy. The CISTO Study (NCT03933826) is a pragmatic, prospective observational cohort study comparing medical therapy (i.e., intravesical therapy or systemic immunotherapy) with radical cystectomy for recurrent high-risk NMIBC. Here we report on the design and progress of the CISTO Study. METHODS: 900 patients with recurrent high-risk NMIBC that has failed first-line BCG and who have chosen to undergo standard of care treatment will be enrolled. Patient stakeholders helped determine the primary outcome: 12-month patient-reported QOL using the EORTC QLQ-C30. Secondary outcomes include urinary and sexual function, decisional regret, financial distress, healthcare utilization, return to work/normal activities, progression, and recurrence-free, metastasis-free, and overall survival. Participants will be followed for up to 3 years. RESULTS: Enrollment is active at 32 sites across the US, including 23 university-based centers and 9 community sites. As of November 1, 2021, 173 participants have been enrolled, 104 of whom chose medical therapy and 69 of whom chose radical cystectomy. The completion rate for the primary outcome of QOL at 12 months is 94% (15 out of 16 participants to date). The inclusion of electronic consent and collection of PROs allowed recruitment and follow-up to continue remotely during the COVID-19 pandemic. Significant pandemic-related challenges have included slow study start-up at sites, staffing, periods of suspension, and delays in patients obtaining care. Strategies to address these challenges include improved methods for onboarding and training sites, all-site communication, confirming study eligibility, abstracting EHR data, and remote monitoring while adhering to the highest study standards. CONCLUSIONS: The CISTO Study will compare patient reported outcomes for those undergoing medical therapy with radical cystectomy for recurrent high-risk NMIBC. The CISTO Study has the potential to fill critical evidence gaps and provide for personalized, patient-centered care. Source of Funding: This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-2017C3-9380) © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e491 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Gore More articles by this author Erika Wolff More articles by this author Bryan Comstock More articles by this author Kristin Follmer More articles by this author Michael Nash More articles by this author On Ho More articles by this author Stephanie Chisolm More articles by this author Doug MacLean More articles by this author Jenney Lee More articles by this author Sarah Lawrence More articles by this author Danielle Lavallee More articles by this author Yair Lotan More articles by this author Gary Steinberg More articles by this author Sima Porten More articles by this author Larry Kessler More articles by this author Angela Smith More articles by this author CISTO Collaborative More articles by this author Expand All Advertisement PDF DownloadLoading ...