NeuroSAFE robot-assisted laparoscopic prostatectomy versus standard robot-assisted laparoscopic prostatectomy for men with localised prostate cancer (NeuroSAFE PROOF): protocol for a randomised controlled feasibility study

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Abstract

Introduction

Robot-assisted laparoscopic prostatectomy (RALP) offers potential cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP. There is reluctance, however, to perform NS RALP when there are concerns that the cancer extends beyond the capsule of the prostate into the NVB, as NS RALP in this instance increases the risk of a positive surgical margin (PSM). The NeuroSAFE technique involves intraoperative fresh-frozen section analysis of the posterolateral aspect of the prostate margin to assess whether cancer extends beyond the capsule. There is evidence from large observational studies that functional outcomes can be improved and PSM rates reduced when the NeuroSAFE technique is used during RALP. To date, however, there has been no randomised controlled trial (RCT) to substantiate this finding. The NeuroSAFE PROOF feasibility study is designed to assess whether it is feasible to randomise men to NeuroSAFE RALP versus a control arm of ‘standard of practice’ RALP.

Methods

NeuroSAFE PROOF feasibility study will be a multicentre, single-blinded RCT with patients randomised 1:1 to either NeuroSAFE RALP (intervention) or standard RALP (control). Treatment allocation will occur after trial entry and consent. The primary outcome will be assessed as the successful accrual of 50 men at three sites over 15 months. Secondary outcomes will be used to aid subsequent power calculations for the definitive full-scale RCT and will include rates of NS; PSM; biochemical recurrence; adjuvant treatments; and patient-reported functional outcomes on potency, continence and quality of life.

Ethics and dissemination

NeuroSAFE PROOF has ethical approval (Regional Ethics Committee reference 17/LO/1978). NeuroSAFE PROOF is supported by National Institute for Healthcare Research Research for Patient Benefit funding (NIHR reference PB-PG-1216-20013). Findings will be made available through peer-reviewed publications.

Trial registration number

NCT03317990.

Related collections

Most cited references 20

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Systematic review and meta-analysis of studies reporting potency rates after robot-assisted radical prostatectomy.

Vincenzo Ficarra, Giacomo Novara, Thomas E. Ahlering … (2012)

Although the initial robot-assisted radical prostatectomy (RARP) series showed 12-mo potency rates ranging from 70% to 80%, the few available comparative studies did not permit any definitive conclusion about the superiority of this technique when compared with retropubic radical prostatectomy (RRP) and laparoscopic radical prostatectomy (LRP). The aims of this systematic review were (1) to evaluate the current prevalence and the potential risk factors of erectile dysfunction after RARP, (2) to identify surgical techniques able to improve the rate of potency recovery after RARP, and (3) to perform a cumulative analysis of all available studies comparing RARP versus RRP or LRP. A literature search was performed in August 2011 using the Medline, Embase, and Web of Science databases. Only comparative studies or clinical series including >100 cases reporting potency recovery outcomes were included in this review. Cumulative analysis was conducted using Review Manager v.4.2 software designed for composing Cochrane Reviews (Cochrane Collaboration, Oxford, UK). We analyzed 15 case series, 6 studies comparing different techniques in the context of RARP, 6 studies comparing RARP with RRP, and 4 studies comparing RARP with LRP. The 12- and 24-mo potency rates ranged from 54% to 90% and from 63% to 94%, respectively. Age, baseline potency status, comorbidities index, and extension of the nerve-sparing procedure represent the most relevant preoperative and intraoperative predictors of potency recovery after RARP. Available data seem to support the use of cautery-free dissection or the use of pinpointed low-energy cauterization. Cumulative analyses showed better 12-mo potency rates after RARP in comparison with RRP (odds ratio [OR]: 2.84; 95% confidence interval [CI]: 1.46-5.43; p=0.002). Only a nonstatistically significant trend in favor of RARP was reported after comparison with LRP (OR: 1.89; p=0.21). The incidence of potency recovery after RARP is influenced by numerous factors. Data coming from the present systematic review support the use of a cautery-free technique. This update of previous systematic reviews of the literature showed, for the first time, a significant advantage in favor of RARP in comparison with RRP in terms of 12-mo potency rates. Copyright © 2012. Published by Elsevier B.V.

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Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

Jenny L Donovan, Lars Holmberg, Freddie Hamdy … (2017)

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Anatomical grades of nerve sparing: a risk-stratified approach to neural-hammock sparing during robot-assisted radical prostatectomy (RARP).

Ashutosh K Tewari, Abhishek Srivastava, Michael Huang … (2011)

• To report the potency and oncological outcomes of patients undergoing robot-assisted radical prostatectomy (RARP) using a risk-stratified approach based on layers of periprostatic fascial dissection. • We also describe the surgical technique of complete hammock preservation or nerve sparing grade 1. • This is a retrospective study of 2317 patients who had robotic prostatectomy by a single surgeon at a single institution between January 2005 and June 2010. • Included patients were those with ≥ 1 year of follow-up and who were potent preoperatively, defined as having a sexual health inventory for men (SHIM) questionnaire score of >21; thus, the final number of patients in the study cohort was 1263. • Patients were categorized pre-operatively by a risk-stratified approach into risk grades 1-4, where risk grade 1 patients received nerve-sparing grade 1 or complete hammock preservation and so on for risk grades 2-4, as long as intraoperative findings permitted the planned nerve sparing. • We considered return to sexual function post-operatively by two criteria: i) ability to have successful intercourse (score of ≥ 4 on question 2 of the SHIM) and ii) SHIM >21 or return to baseline sexual function. • There was a significant difference across different NS grades in terms of the percentages of patients who had intercourse and returned to baseline sexual function (P < 0.001), with those that underwent NS grade 1 having the highest rates (90.9% and 81.7%) as compared to NS grades 2 (81.4% and 74.3%), 3 (73.5% and 66.1%), and 4 (62% and 54.5%). • The overall positive surgical margin (PSM) rates for patients with NS grades 1, 2, 3, and 4 were 9.9%, 8.1%, 7.2%, and 8.7%, respectively (P = 0.636). • The extraprostatic extension rates were 11.6%, 14.3%, 29.3%, and 36.2%, respectively (P < 0.001). • Similarly, in patients younger than 60, intercourse and return to baseline sexual function rates were 94.9% and 84.3% for NS grade 1 as compared to 85.5% and 77.2% for NS grades 2, 76.9% and 69% for NS grades 3, and 64.8% and 57.7% for NS Grade 4 (P < 0.001). • The risk-stratified approach and anatomical technique of neural-hammock sparing described in the present manuscript was effective in improving potency outcomes of patients without compromising cancer control. • Patients with greater degrees of NS had higher rates of intercourse and return to baseline sexual function without an increase in PSM rates. © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2019

Publication date (Electronic): 11 June 2019

Volume: 9

Issue: 6

Electronic Location Identifier: e028132

Affiliations

[1 ] departmentDepartment of Urology , University College Hospital London , London, UK

[2 ] departmentDivision of Surgery & Interventional Science , University College London Medical School , London, UK

[3 ] departmentDepartment of Histopathology , University College Hospital London , London, UK

[4 ] departmentDepartment of Radiology , University College Hospital London , London, UK

[5 ] North Bristol NHS Trust , Westbury on Trym, Bristol, UK

[6 ] Sheffield Teaching Hospitals NHS Foundation Trust , Sheffield, Sheffield, UK

[7 ] departmentDepartment of Urology , Lister Hospital , Stevenage, UK

[8 ] departmentMartini Klinik, Department of Urology , University Hospital Eppendorf , Hamburg, Germany

Author notes

[Correspondence to ] Eoin Dinneen; eoindinneen@ 123456gmail.com

Author information

Eoin Dinneen http://orcid.org/0000-0002-4309-3257

Jack Grierson http://orcid.org/0000-0003-3952-5640

Article

Publisher ID: bmjopen-2018-028132

DOI: 10.1136/bmjopen-2018-028132

PMC ID: 6575674

PubMed ID: 31189680

SO-VID: ab7833f8-5abb-423d-b3f2-c8d7cac05568

License:

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

History

Date received : 23 November 2018

Date revision received : 11 April 2019

Date accepted : 15 May 2019

Funding

Funded by: NIHR Research for Patient Benefit;

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ScienceOpen disciplines: Medicine

Keywords: neurosafe,nerve sparing,frozen section,robotic prostatectomy,prostate cancer

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ScienceOpen disciplines: Medicine

Keywords: neurosafe, nerve sparing, frozen section, robotic prostatectomy, prostate cancer

NeuroSAFE robot-assisted laparoscopic prostatectomy versus standard robot-assisted laparoscopic prostatectomy for men with localised prostate cancer (NeuroSAFE PROOF): protocol for a randomised controlled feasibility study

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Most cited references 20

Systematic review and meta-analysis of studies reporting potency rates after robot-assisted radical prostatectomy.

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

Anatomical grades of nerve sparing: a risk-stratified approach to neural-hammock sparing during robot-assisted radical prostatectomy (RARP).

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