MP50-16 NEUROSAFE PROOF: A MULTI-CENTRE, PRAGMATIC, RCT FOR MEN UNDERGOING ROBOT-ASSISTED RADICAL PROSTATECTOMY. UPDATE ON A TRIAL IN PROGRESS

Abstract

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy III (MP50)1 Sep 2021MP50-16 NEUROSAFE PROOF: A MULTI-CENTRE, PRAGMATIC, RCT FOR MEN UNDERGOING ROBOT-ASSISTED RADICAL PROSTATECTOMY. UPDATE ON A TRIAL IN PROGRESS Eoin Dinneen, Jacques Grierson, Rosemary Clow, Aiman Haider, Alex Freeman, Clare Allen, NeuroSAFE PROOF Trial Team, and Greg Shaw Eoin DinneenEoin Dinneen More articles by this author , Jacques GriersonJacques Grierson More articles by this author , Rosemary ClowRosemary Clow More articles by this author , Aiman HaiderAiman Haider More articles by this author , Alex FreemanAlex Freeman More articles by this author , Clare AllenClare Allen More articles by this author , NeuroSAFE PROOF Trial Team More articles by this author , and Greg ShawGreg Shaw More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002076.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Robot-assisted Radical Prostatectomy (RARP) is an effective cure for organ confined prostate cancer but is associated with considerable post-operative functional toxicity. The NeuroSAFE technique (intra-operative frozen section analysis of the neurovascular structure adjacent margin) may help improve functional outcomes by promoting safe nerve-sparing (NS) RARP without compromising on oncological outcomes. NeuroSAFE technique has reported favourably in retrospective, single-centre studies but has never been evaluated prospectively by a randomised study. The NeuroSAFE PROOF Feasibility Study has succeeded in demonstrating feasibility and has facilitated opening of the full-scale, definitively powered NeuroSAFE Randomized Controlled Trial (RCT) (NCT03317990). We report on the design and progress of the full NeuroSAFE PROOF RCT. METHODS: Potent men (IIEF-5>21) with localised prostate cancer at 4 regional uro-oncology centres in the UK (UCLH, Bristol, Sheffield and Glasgow) are eligible. Participants are randomised 1:1 to RARP with NS decision guided by standard of care (clinical information, DRE and pre-operative mpMRI surgical plan) vs. RARP with NS decision guided by standard of care information and the NeuroSAFE technique. The primary outcome is erectile function recovery assessed by IIEF-5 score >15 at 12-months. Important secondary outcomes include detailed peri-operative outcomes, histological outcomes, post-operative complications, biochemical recurrence rates, urinary continence (assessed by ICIQ), and health related quality of life (assessed by Rand-36 and EQ-5D-5L). Aiming to demonstrate a difference of 15% in erectile function recovery rates between the arms, a total of 404 men will need to be randomised and treated. Patients will continue to be followed for outcomes until 5 years after treatment. RESULTS: At the time of writing, 159 men have been recruited and treated with RARP as per random allocation at the 4 participating sites. The independent DMC has met thrice to ensure the oncological safety of the trial and will continue to review the data at intervals. Covid-19 has led to significant challenges, including suspension of recruitment and difficulties performing follow-up. The trial team have developed new methods of recruitment, consent and follow-up to ensure conduct of the study remains in line with the highest standards of trial conduct. CONCLUSIONS: The NeuroSAFE technique has been reported as a method to optimise outcomes for men undergoing RARP for over a decade, but, in the absence of level 1 evidence, equipoise remains. We hope that our full trial (the first RCT of the NeuroSAFE technique in the world) will provide the evidence to establish whether what has long been a promising technique truly improves outcomes for men undergoing RP. Source of Funding: NeuroSAFE PROOF is funded by the JP Moulton Charitable Foundation © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e892-e893 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Eoin Dinneen More articles by this author Jacques Grierson More articles by this author Rosemary Clow More articles by this author Aiman Haider More articles by this author Alex Freeman More articles by this author Clare Allen More articles by this author NeuroSAFE PROOF Trial Team More articles by this author Greg Shaw More articles by this author Expand All Advertisement Loading ...