To review how response to neoadjuvant therapy (NAT) is assessed in clinical trials of muscle-invasive bladder cancer (MIBC), and to determine whether trial-derived evidence can inform response evaluation in contemporary practice.
We searched PubMed, Embase and ClinicalTrials.gov through August 2025 for randomised controlled trials (RCTs) of neoadjuvant chemotherapy, chemo-immunotherapy or immunotherapy in non-metastatic MIBC (cT2-T4a N0-1 M0), and for prospective single-arm chemo-immunotherapy or immunotherapy trials. We extracted data on imaging modality and coverage, endoscopic and biomarker-based assessment, timing, correlation with final pathology and diagnostic accuracy. Given heterogeneity in definitions and reporting, no meta-analysis was performed.
We identified 22 studies, including 14 RCTs. Most incorporated response evaluation, yet methods differed widely. Computed tomography (CT) was the most frequent modality in RCTs, whereas bladder magnetic resonance imaging (MRI) predominated in recent single-arm immunotherapy trials. Timing was inconsistent and usually post-treatment; only two trials performed interim assessment. Endoscopic evaluation was concentrated in bladder-preservation trials, and circulating tumour DNA (ctDNA) was used selectively. Only five studies correlated restaging with final pathology; multiparametric MRI scored with nacVI-RADS predicted pathological complete response with 72%-83% accuracy. No trial reported imaging accuracy for distant metastases after NAT.
Response assessment after NAT in MIBC remains insufficiently standardised. Trial-derived evidence supports cross-sectional imaging before radical local treatment, with CT the most established modality, largely reflecting trial-design conventions and availability rather than demonstrated diagnostic superiority; bladder MRI is more accurate for local restaging. Emerging biomarkers such as ctDNA require validation. Harmonising timing, modalities and response definitions is needed to enable evidence-based treatment adaptation.
BJU international. 2026 Aug 05 [Epub ahead of print]
Roberto Contieri, Bas W G van Rhijn, Richard Cathomas, Anja Lorch, Daniela Oprea-Lager, Paramananthan Mariappan, Francesco Sanguedolce, Antoine G van der Heijden, Laura S Mertens, EAU Imaging Section
Department of Urology, Istituto Nazionale Tumori di Napoli, IRCCS 'G. Pascale', Naples, Italy., Department of Surgical Oncology (Urology), Netherlands Cancer Institute, Amsterdam, The Netherlands., Division of Oncology/Hematology, Kantonsspital Graubünden, Chur, Switzerland., Department of Medical Oncology and Hematology, University Hospital Zürich, Zürich, Switzerland., Department of Medical Imaging, Radboud University Medical Centre, Nijmegen, The Netherlands., Edinburgh Bladder Cancer Surgery (EBCS), Department of Urology, Western General Hospital, Edinburgh, UK., Department of Medicine, Surgery and Pharmacy, Università degli Studi di Sassari, Sassari, Italy., Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.