Lba03-07 imperial prostate-4 comparative healthcare research outcomes of novel surgery in prostate cancer (ip4-chronos): early feasibility, safety and functional outcomes from a pilot rct

You have accessJournal of UrologyCME1 Apr 2023LBA03-07 IMPERIAL PROSTATE-4 COMPARATIVE HEALTHCARE RESEARCH OUTCOMES OF NOVEL SURGERY IN PROSTATE CANCER (IP4-CHRONOS): EARLY FEASIBILITY, SAFETY AND FUNCTIONAL OUTCOMES FROM A PILOT RCT Deepika Reddy, Tim Dudderidge, Stuart McCracken, Manit Arya, Consuelo Nohpal de la Rosa, Francesca Fiorentino, Emily Day, Andrew Prevost, Mark Emberton, John Staffurth, Sarbjinder Sandhu, Richard Hindley, Nimalan Arumainayagam, Matthew Sydes, Vincent Khoo, Mathias Winkler, Taimur Shah, and Hashim Ahmed Deepika ReddyDeepika Reddy More articles by this author , Tim DudderidgeTim Dudderidge More articles by this author , Stuart McCrackenStuart McCracken More articles by this author , Manit AryaManit Arya More articles by this author , Consuelo Nohpal de la RosaConsuelo Nohpal de la Rosa More articles by this author , Francesca FiorentinoFrancesca Fiorentino More articles by this author , Emily DayEmily Day More articles by this author , Andrew PrevostAndrew Prevost More articles by this author , Mark EmbertonMark Emberton More articles by this author , John StaffurthJohn Staffurth More articles by this author , Sarbjinder SandhuSarbjinder Sandhu More articles by this author , Richard HindleyRichard Hindley More articles by this author , Nimalan ArumainayagamNimalan Arumainayagam More articles by this author , Matthew SydesMatthew Sydes More articles by this author , Vincent KhooVincent Khoo More articles by this author , Mathias WinklerMathias Winkler More articles by this author , Taimur ShahTaimur Shah More articles by this author , and Hashim AhmedHashim Ahmed More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003426.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Randomised comparative outcomes are unavailable for focal therapy in localised prostate cancer. IP4 CHRONOS is an RCT aimed to optimise recruitment of patients dependent upon clinician and patient equipoise. METHODS: Patients with clinically significant localised prostate cancer could opt for IP4-CHRONOS-A or IP4-CHRONOS-B. IP4-CHRONOS-A randomised patients 1:1 between focal therapy(HIFU or cryotherapy) versus radical therapy(radiation or prostatectomy). Using a multi-arm-multistage(MAMS)design, IP4-CHRONOS-B randomised between focal alone(FTA) and focal combined with neoadjuvant medication (12 weeks of finasteride [FTF] or bicalutamide [FTB]). We report the pilot phase outcomes on feasibility of randomisation, early safety outcomes relative to treatment and genito-urinary functional outcomes following over 12 months treatment in IP4-CHRONOS-B. IP4-CHRONOS had ethics committee approval and was registered(ISRCTN17796995). RESULTS: Following COVID-19 adjustments, IP4-CHRONOS-A did not meet its feasibility target. Having randomised 36 patients via10 sites with a recruitment rate (95% CI) of 18% (13-23) & randomisation rate of 97%(86-100). IP4-CHRONOS-B did meet its target, randomising 64 patients across 7 sites with a recruitment rate of 43% (35-52) &randomisation rate of 100%(94-100). The only patients to withdraw were randomised to the radical arm of IP4-CHRONOS-A(4[22%]) All patients in IP4-CHRONOS-B were compliant with neoadjuvant treatment.Only 1 patient reported CTCAE V4.0 grade≥3 adverse event(AE) in IP4-CHRONOS-A following radical treatment, another patient in each arm reported a serious adverse event(SAE) following treatment. 1 &3 patients reported an AE &SAE following FTB. 2 and 3 patients reported an AE &SAE following FTA. No patients reported any AE or SAE event following FTF. Figure 1 demonstrates generally well preserved genito-urinary function following focal treatment±neoadjuvant treatment. CONCLUSIONS: IP4-CHRONOS evaluated patient and physician equipoise regarding focal therapy. Traditional randomisation was not feasible due to strong patient preferences, while a MAMS RCT investigating the role of neoadjuvant agents combined with focal therapy was. Source of Funding: Prostate Cancer UK © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1194 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Deepika Reddy More articles by this author Tim Dudderidge More articles by this author Stuart McCracken More articles by this author Manit Arya More articles by this author Consuelo Nohpal de la Rosa More articles by this author Francesca Fiorentino More articles by this author Emily Day More articles by this author Andrew Prevost More articles by this author Mark Emberton More articles by this author John Staffurth More articles by this author Sarbjinder Sandhu More articles by this author Richard Hindley More articles by this author Nimalan Arumainayagam More articles by this author Matthew Sydes More articles by this author Vincent Khoo More articles by this author Mathias Winkler More articles by this author Taimur Shah More articles by this author Hashim Ahmed More articles by this author Expand All Advertisement PDF downloadLoading ...