ArticleEuropean urology oncology2026
AI-MIRACLE: Artificial Intelligence and MultIpaRAmetric MRI Predict CLinical OutcomEs to Neoadjuvant Immunotherapy in Patients with Muscle-invasive Bladder Cancer Undergoing Radical Cystectomy.
Article in European urology oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02736266 (An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab), which is not on this map. Not yet cited in PubMed.
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An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab (MK-3475) Before Cystectomy for Patients With Muscle-invasive Urothelial Bladder Cancer.
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Abstract
BACKGROUND AND
objectiveNeoadjuvant immune-checkpoint inhibitors (ICIs) in muscle-invasive bladder cancer (MIBC) were tested in patient's ineligible for cisplatin-based chemotherapy. The PURE-01 trial (NCT02736266) evaluated three courses of pembrolizumab before radical cystectomy (RC). We developed AI-MIRACLE, an international study assessing artificial intelligence (AI) and multiparametric magnetic resonance imaging (mpMRI) for predicting treatment response.
methodsThis multi-institutional study included data acquisition in Italy, and centralized analysis in the United States. Among 112 PURE-01 patients, pre- and post-ICI MRIs were analyzed. T2-weighted signal intensities were standardized for radiomics (Image Biomarker Standardization Initiative-compatible Python-based Computational Environment for Radiological Research (pyCERR)) and deep feature extraction (AI-BLADE toolbox using VGG19). Diffusion-weighted (DW) and dynamic contrast-enhanced (DCE) MRI data underwent model-based analysis. Supervised machine learning algorithms (elastic net, random forest) were trained and cross-validated to predict pathological major response (pMR:ypT<2N0 residual disease) and pathological complete response (pCR: ypT0) pathological response. KEY FINDINGS AND LIMITATIONS: The predictive models using post-ICI mpMRI with either a combination of radiomics and DCE-derived features or radiomics alone achieved the same high accuracy, with an area under the receiver operating characteristic curve (AUC) of 0.96 for pMR. A shape-based radiomic model achieved an AUC of 0.86 for predicting pCR. These models outperformed benchmark models based on clinical predictors. CONCLUSIONS AND CLINICAL IMPLICATIONS: Shape-based radiomics, DCE-derived features, and deep features may serve as noninvasive imaging biomarkers for predicting response to neoadjuvant pembrolizumab in MIBC. This imaging-based approach provides a non-invasive assessment of treatment response following neoadjuvant immunotherapy, which may help inform bladder-preserving management decisions prior to definitive surgery.
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