Radical Cystectomy (bladder Removal) Against Intravesical BCG Immunotherapy for High-risk Non-muscle Invasive Bladder Cancer (BRAVO): a Protocol for a Randomised Controlled Feasibility Study

Overview

Journal BMJ Open

Specialty General Medicine

Date 2017 Aug 13

PMID 28801444

Citations 15

Authors

Jamie B Oughton

Heather Poad

Maureen Twiddy

Michelle Collinson

Victoria Hiley

Kathryn Gordon

Mark Johnson

Sunjay Jain

Aidan P Noon

Rohit Chahal

Matt Simms

Mohantha Dooldeniya

Phillip Koenig

Louise Goodwin

Julia M Brown

James W F Catto

Affiliations

Soon will be listed here.

Abstract

Introduction: High-risk non-muscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease that can be difficult to predict. While around 25% of cancers progress to invasion and metastases, the remaining majority of tumours remain within the bladder. It is uncertain whether patients with HRNMIBC are better treated with intravesical maintenance BCG (mBCG) immunotherapy or primary radical cystectomy (RC). A definitive randomised controlled trial (RCT) is needed to compare these two different treatments but may be difficult to recruit to and has not been attempted to date. Before undertaking such an RCT, it is important to understand whether such a comparison is possible and how best to achieve it.

Methods And Analysis: BRAVO is a multi-centre, parallel-group, mixed-methods, individually randomised, controlled, feasibility study for patients with HRNMIBC. Participants will be randomised to receive either mBCG immunotherapy or RC. The primary objective is to assess the feasibility and acceptability of performing the definitive phase III trial via estimation of eligibility and recruitment rates, assessing uptake of allocated treatment and compliance with mBCG, determining quality-of-life questionnaire completion rates and exploring reasons expressed by patients for declining recruitment into the study. We aim to recruit 60 participants from six centres in the UK. Surgical trials with disparate treatment options find recruitment challenging from both the patient and clinician perspective. By building on the experiences of other similar trials through implementing a comprehensive training package aimed at clinicians to address these challenges (qualitative substudy), we hope that we can demonstrate that a phase III trial is feasible.

Ethics And Dissemination: The study has ethical approval (16/YH/0268). Findings will be made available to patients, clinicians, the funders and the National Health Service through traditional publishing and social media.

Trial Registration Number: ISRCTN12509361; Pre results.

Citing Articles

Real-world outcomes for high-risk non-muscle-invasive bladder cancer: screened patients for the BRAVO trial.

Conroy S, Jubber I, Noon A, Rosario D, Griffin J, Morgan S BJU Int. 2024; 135(2):329-338.

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Impact of an optimized surveillance protocol based on the European Association of Urology substratification on surveillance costs in patients with primary high-risk non-muscle-invasive bladder cancer.

Fujita N, Hatakeyama S, Okita K, Momota M, Tobisawa Y, Yoneyama T PLoS One. 2023; 18(2):e0275921.

PMID: 36763567 PMC: 9916549. DOI: 10.1371/journal.pone.0275921.

Risk score-based substratification improves surveillance costs after transurethral resection of bladder tumor in patients with primary high-risk non-muscle-invasive bladder cancer.

Fujita N, Hatakeyama S, Momota M, Tobisawa Y, Yoneyama T, Yamamoto H Sci Rep. 2022; 12(1):13786.

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Relevance of A Disintegrin and Metalloproteinase Domain-Containing (ADAM)9 Protein Expression to Bladder Cancer Malignancy.

Moriwaki M, Le T, Sung S, Jotatsu Y, Yang Y, Hirata Y Biomolecules. 2022; 12(6).

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Expression of Membranous CD155 Is Associated with Aggressive Phenotypes and a Poor Prognosis in Patients with Bladder Cancer.

Mori K, Matsumoto K, Amano N, Koguchi D, Shimura S, Hagiwara M Cancers (Basel). 2022; 14(6).

PMID: 35326727 PMC: 8946612. DOI: 10.3390/cancers14061576.

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