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Randomized Controlled Trial
. 2025 Apr 20;43(12):1417-1428.
doi: 10.1200/JCO.23.02398. Epub 2025 Jan 14.

Randomized Comparison of Magnetic Resonance Imaging Versus Transurethral Resection for Staging New Bladder Cancers: Results From the Prospective BladderPath Trial

Richard T Bryan  1 , Wenyu Liu  2 , Sarah J Pirrie  3 , Rashid Amir  4 , Jean Gallagher  5 , Ana I Hughes  3 , Kieran P Jefferson  6 , Allen Knight  5   7 , Veronica Nanton  8 , Harriet P Mintz  9 , Ann M Pope  3 , Jacob Cherian  10 , Kingsley Ekwueme  11 , Lyndon Gommersall  12 , Giles Hellawell  13 , Paul Hunter-Campbell  14 , Gokul Kanda Swamy  15 , Sanjeev Kotwal  16 , Vivekanandan Kumar  17 , David Mak  18 , Amar Mohee  19 , Thiagarajan Nambirajan  20 , Douglas G Ward  1 , Steven J Kennish  21 , James W F Catto  21   22 , Prashant Patel  23 , Nicholas D James  24   25 ; BladderPath Collaborative Group
Collaborators, Affiliations
Randomized Controlled Trial

Randomized Comparison of Magnetic Resonance Imaging Versus Transurethral Resection for Staging New Bladder Cancers: Results From the Prospective BladderPath Trial

Richard T Bryan et al. J Clin Oncol. .

Erratum in

Abstract

Purpose: Transurethral resection of bladder tumor (TURBT) is the initial staging procedure for new bladder cancers (BCs). For muscle-invasive bladder cancers (MIBCs), TURBT may delay definitive treatment. We investigated whether definitive treatment can be expedited for MIBC using flexible cystoscopic biopsy and multiparametric magnetic resonance imaging (mpMRI) for initial staging.

Patients and methods: We conducted a prospective open-label, randomized study conducted within 17 UK hospitals (registered as ISRCTN 35296862). Participants with suspected new BC were randomly assigned 1:1 to TURBT-staged or mpMRI-staged care, with minimization factors of sex, age, and clinician visual assessment of stage. Blinding was not possible. Patients unable/unwilling to undergo mpMRI or with previous BC were ineligible. The study had two stages with separate primary outcomes of feasibility and time to correct treatment (TTCT) for MIBC, respectively.

Results: Between May 31, 2018, and December 31, 2021, 638 patients were screened, and 143 participants randomly assigned to TURBT (n = 72; 55 males, 15 MIBCs) or initial mpMRI (n = 71; 53 males, 14 MIBCs). For feasibility, 36 of 39 (92% [95% CI, 79 to 98]) participants with suspected MIBC underwent mpMRI. The median TTCT for participants with MIBC was significantly shorter with initial mpMRI (n = 12, 53 days [95% CI, 20 to 89] v n = 14, 98 days [95% CI, 72 to 125] for TURBT, log-rank P .02). There was no detriment for participants with non-MIBC (median TTCT: n = 30, 17 days [95% CI, 8 to 25] for mpMRI v n = 28, 14 days [95% CI, 10 to 29] for TURBT, log-rank P = .67). No serious adverse events were reported.

Conclusion: The mpMRI-directed pathway led to a 45-day reduction in TTCT for MIBC. Incorporating mpMRI ahead of TURBT into the standard pathway was beneficial for all patients with suspected MIBC.

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Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Richard T. Bryan

Consulting or Advisory Role: Cystotech ApS, Informed Genomics Ltd, AstraZeneca

Research Funding: Janssen, QED Therapeutics, Urogen Pharma

Uncompensated Relationships: Action Bladder Cancer UK (charity)

Ana I. Hughes

Research Funding: AstraZeneca

Kieran P. Jefferson

Employment: Medica Reporting (I)

Leadership: Warwickshire Urology

Stock and Other Ownership Interests: Warwickshire Urology

Travel, Accommodations, Expenses: Angiodynamic

Jacob Cherian

Travel, Accommodations, Expenses: Janssen Oncology

Kingsley Ekwueme

Travel, Accommodations, Expenses: Ferring

Lyndon Gommersall

Travel, Accommodations, Expenses: medac Pharma

Paul Hunter-Campbell

Employment: Breakwater Medical

Leadership: Breakwater Medical

Travel, Accommodations, Expenses: Hollister

Uncompensated Relationships: Hollister

Amar Mohee

Honoraria: Becton Dickinson

Travel, Accommodations, Expenses: Becton Dickinson

Thiagarajan Nambitajan

Honoraria: Astellas Pharma

Douglas G. Ward

Honoraria: AstraZeneca

Patents, Royalties, Other Intellectual Property: Royalty for GALEAS Bladder (Inst)

Steven J. Kennish

Employment: This Is My Healthcare

James W.F. Catto

Consulting or Advisory Role: AstraZeneca/MedImmune, Janssen, Ferring, Roche, Pfizer

Speakers' Bureau: Roche, AstraZeneca/MedImmune, Bristol Myers Squibb Foundation, Pfizer, Medac, Ipsen, Astellas Pharma

Research Funding: Roche/Genentech

Travel, Accommodations, Expenses: Janssen medical Affairs

Nicholas D. James

Honoraria: Sanofi, Bayer, Janssen, Astellas Pharma

Consulting or Advisory Role: Sanofi, Bayer, Astellas Pharma, Janssen, Clovis Oncology, EUSA pharma, Pfizer

Speakers' Bureau: Pierre Fabre, Ferring, Sanofi, Astellas Pharma, Janssen Oncology, Merck, AstraZeneca

Research Funding: Janssen (Inst), Astellas Pharma (Inst), Pfizer (Inst), Sanofi (Inst), Novartis (Inst), AstraZeneca (Inst)

Travel, Accommodations, Expenses: Sanofi, Janssen, Bayer

No other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
CONSORT diagram. Shaded boxes: Population in primary outcome analysis for time to correct treatment, TTCT (patients with probable MIBC confirmed as MIBC by TURBT or cystectomy, or treated with MIBC therapy, n = 14 in Pathway 1 and n = 12 in Pathway 2). For full NIHR Health Technology Assessment report, please refer to the study by James et al. MIBC, muscle-invasive bladder cancer; NIHR, National Institute for Health Research; NMIBC, non–muscle-invasive bladder cancer; PI, principal investigator; TTCT, time to correct treatment; TURBT, transurethral resection of bladder tumor.
FIG 2.
FIG 2.
Examples of mpMRI images from recruited participants for (A) noninvasive (pTa) and (B) invasive (pT3b) bladder cancers initially thought to be possible MIBC (Likert 3-5) at flexible cystoscopy. White arrows indicate intact muscularis propria. Black arrows indicate loss of normal muscularis propria because of invasive tumor. For the full NIHR Health Technology Assessment report, please refer to the study by James et al. ADC, apparent diffusion coefficient; DCEI, dynamic contrast enhancement image; DWI, diffusion-weighted imaging; MIBC, muscle-invasive bladder cancer; mpMRI, multiparametric magnetic resonance imaging; NIHR, National Institute for Health Research; T2, MRI T2 weighted; VIRADS, Vesical Imaging-Reporting and Data System.
FIG 3.
FIG 3.
(A) Kaplan-Meier curves of TTCT by pathway for participants with possible MIBC who were confirmed MIBC and received a correct treatment; (B) swimmer plot for Pathway 1 participants with possible MIBC; (C) swimmer plot for Pathway 2 participants with possible MIBC; (D) Kaplan-Meier curves of TTCT by pathway for participants with probable NMIBC who were confirmed NMIBC and received a correct treatment; (E) swimmer plot for Pathway 1 participants with probable NMIBC; and (F) swimmer plot for Pathway 2 participants with probable NMIBC. For the Kaplan-Meier curves, blue dashed lines represent Pathway 1 (TURBT pathway) and red lines represent Pathway 2 (mpMRI-guided pathway). For the swimmer plots, the yellow bars illustrate TTCT. For full NIHR Health Technology Assessment report, please refer to the study by James et al. MIBC, muscle-invasive bladder cancer; mpMRI, multiparametric magnetic resonance imaging; MRI, magnetic resonance imaging; NIHR, National Institute for Health Research; NMIBC, non–muscle-invasive bladder cancer; TTCT, time to correct treatment; TURBT, transurethral resection of bladder tumor.
FIG A1.
FIG A1.
BladderPath study schema. chemo, chemotherapy; MIBC, muscle-invasive bladder cancer; mpMRI, multiparametric magnetic resonance imaging; NMIBC, non–muscle-invasive bladder cancer; RT, radiotherapy; TURBT, transurethral resection of bladder tumor.
FIG A2.
FIG A2.
Kaplan-Meier curves of time to correct treatment by pathway for all randomly assigned participants.
See this image and copyright information in PMC

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