Replacing TURBT with mpMRI for staging MIBC: Pilot data from the BladderPath study.

Authors

Nicholas James

Nicholas D. James

Queen Elizabeth Hospital, Birmingham, United Kingdom

Nicholas D. James , Sarah Pirrie , Wenyu Liu , Rashid Amir , Jean Gallagher , Ana Hughes , Kieran Jefferson , Allen Knight , Veronica Nanton , Harriet Paige Mintz , Ann Pope , James WF Catto , Prashant Patel , Richard T. Bryan

Organizations

Queen Elizabeth Hospital, Birmingham, United Kingdom, School of Cancer Sciences, Birmingham, United Kingdom, Cancer Research UK Clinical Trials Unit, Birmingham, United Kingdom, University Hospitals Birmingham NHS Trust, Birmingham, United Kingdom, University of Birmingham, Birmingham, United Kingdom, University Hospitals Coventry and Warwick, Coventry, United Kingdom, Action on Bladder Cancer, Tetbury, United Kingdom, Warwick Medical School, Coventry, United Kingdom, University of Warwick Medical School and Queen Elizabeth Hospital, Coventry & Birmingham, United Kingdom, CRUK Institute for Cancer Studies, University of Birmingham, Birmingham, United Kingdom, Academic Urology Unit, University of Sheffield, Sheffield, United Kingdom, School of Cancer Sciences, University of Birmingham, Birmingham, United Kingdom

Research Funding

Other Government Agency
NHS Health Technology Agency.

Background: The diagnostic pathways for bladder cancer are largely unchanged for 30 years. The BladderPath trial objectives are to: improve staging, accelerate treatment, and reduce iatrogenic tumour spread by avoiding TURBT. We hypothesise that substituting TURBT with mpMRI will avoid unnecessary surgery, accelerate correct MIBC treatment and improve outcomes. Methods: A randomised phase 2/3 trial of standard of care (Pathway 1) versus risk-stratified mpMRI-directed care (Pathway 2) in visually-diagnosed incident bladder cancer. Patients with bladder lesions suspicious for malignancy at flexible cystoscopy are stratified by a 5-point Likert scale: strongly agree (1) or agree (2) that the lesion is NMIBC, equivocal (3) NMIBC or MIBC, and agree (4) or strongly agree (5) the lesion is MIBC. All patients are randomised; those with probable NMIBC (Likert 1 & 2) undergo TURBT in both pathways, and those with possible MIBC (Likert 3-5) undergo TURBT (Pathway 1) or mpMRI (Pathway 2). Endpoints: feasibility, time to correct MIBC therapy and clinical progression-free survival. We report preliminary feasibility data. Results: To date, 218 potentially eligible patients have been registered; on cystoscopy, 151 patients had no bladder lesions and 5 were excluded for other reasons. Of 62 patients randomised, we report results from 45 with preliminary data. Of the 21 patients in Pathway 1, 11 patients classified as probable NMIBC underwent TURBT (pathology: 11/11 NMIBC); 9/10 patients classified as possible MIBC underwent TURBT (pathology: 4/9 NMIBC & 5/9 MIBC) and 1 patient incorrectly underwent mpMRI (staging: MIBC). Of the 24 patients in Pathway 2, 11/12 patients classified as probable NMIBC underwent TURBT (pathology: 9/11 NMIBC & 2/11 MIBC) and one patient incorrectly underwent mpMRI (staging: NMIBC); 12 patients classified as possible MIBC underwent mpMRI (staging: 6/12 NMIBC & 6/12 MIBC). Conclusions: A 5-point Likert scale accurately identifies patients with a low risk of MIBC (Likert 1 & 2). It is feasible to randomise possible MIBC patients to TURBT or mpMRI for staging. The study is ongoing to investigate the intermediate outcome of time to correct therapy for MIBC and NMIBC and the final outcome of clinical progression-free survival. Clinical trial information: 35296862.

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Abstract Details

Meeting

2020 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Prostate Cancer; Urothelial Carcinoma; Penile, Urethral, Testicular, and Adrenal Cancers

Track

Urothelial Carcinoma,Adrenal Cancer,Penile Cancer,Prostate Cancer - Advanced,Prostate Cancer - Localized,Testicular Cancer,Urethral Cancer

Sub Track

Imaging

Clinical Trial Registration Number

35296862

Citation

J Clin Oncol 38, 2020 (suppl 6; abstr 446)

Abstract #

446

Poster Bd #

F13

Abstract Disclosures