编者按：2026年美国临床肿瘤学会泌尿生殖系统肿瘤研讨会（ASCO GU）期间，基于数字病理的人工智能预测模型MMAI，在局限性前列腺癌中完成首次国际外部验证的重磅成果，引发全球泌尿肿瘤领域关注。我们在会议现场专访了英国癌症研究所、皇家马斯登医院临床肿瘤学名誉顾问Anna Wilkins教授深度解读这项研究的核心价值、临床落地前景，以及本次大会的前沿突破。

Anna Wilkins教授：本次大会上，我分享了MMAI检测在局限性前列腺癌临床试验队列中完成的首次国际外部独立验证的数据。MMAI全称Multimodal Artificial Intelligence（多模态人工智能）病理模型，也被称为Machine-Learning Morphometric AI（形态计量机器学习AI），是由美国ArteraAI公司研发、专为前列腺癌精准诊疗设计的数字病理AI预后模型，也是目前全球经过最多III期随机对照临床试验（RCT）验证的肿瘤病理AI工具之一。该模型的研发旨在解决传统前列腺癌预后评估的核心痛点：传统临床评分系统无法充分捕捉肿瘤内异质性，风险分层精度不足；基因组分类检测成本高、需额外消耗组织、检测周转周期长，难以在临床大规模普及；基于常规H&E染色切片的AI方案，可直接从病理金标准标本中提取预后信息，无需额外检测，具备低成本、高可及性的核心优势。

 

MMAI检测仅需临床常规诊断流程中已制备的苏木精-伊红（Hematoxylin-Eosin，H&E）染色病理切片，将切片数字化扫描后输入AI算法，即可完成分析，精准预测局限性前列腺癌患者术后/放疗后的疾病复发与远处转移风险。

 

我们这项验证研究，纳入了CHHiP试验（前列腺癌常规分割与大分割调强放疗III期临床试验）中近1800例局限性前列腺癌患者的病理样本与长期随访临床数据。最终结果证实：相较于临床目前通用的标准风险分层系统，MMAI检测对局限性前列腺癌患者的疾病复发、远处转移风险的预测效能，均实现了具有统计学意义的显著提升，为前列腺癌的精准风险分层提供了全新的高等级循证医学证据。

 

Oncology Frontier:First，could you elaborate on the core research findings you presented at this ASCO GU congress?

 

Dr.Anna Wilkins:At this congress，the core data I presented is the first international external independent validation of the MMAI assay in clinical trial cohorts of localized prostate cancer.

 

MMAI，short for Multimodal Artificial Intelligence pathology model，also referred to as Machine-Learning Morphometric AI，is a digital pathology AI prognostic model developed by US-based ArteraAI，specifically designed for the precision diagnosis and treatment of prostate cancer.It is also one of the most extensively validated oncology pathology AI tools globally through phase III randomized controlled trials(RCTs)to date.The model was developed to address the core pain points of traditional prostate cancer prognostic assessment:traditional clinical scoring systems fail to fully capture intratumoral heterogeneity，resulting in insufficient accuracy of risk stratification;genomic classifier assays are associated with high costs，additional tissue consumption，and long turnaround times，making it difficult to achieve large-scale clinical popularization.In contrast，the AI solution based on routine Hematoxylin-Eosin(H&E)stained slides can directly extract prognostic information from gold-standard pathological specimens without additional testing，with the core advantages of low cost and high accessibility.

 

The MMAI assay only requires H&E stained pathological slides that have been routinely prepared during the standard clinical diagnostic workflow.After digital scanning of the slides，the images are input into the AI algorithm to complete the analysis，which can accurately predict the risk of disease recurrence and distant metastasis in patients with localized prostate cancer after surgery or radiotherapy.

 

Our validation study included pathological samples and long-term follow-up clinical data from nearly 1800 patients with localized prostate cancer enrolled in the CHHiP trial(a phase III trial of conventional versus hypofractionated intensity-modulated radiotherapy for prostate cancer).The final results confirmed that，compared with the current standard risk stratification system widely used in clinical practice，the MMAI assay achieved a statistically significant improvement in the predictive performance for disease recurrence and distant metastasis risk in patients with localized prostate cancer，providing new high-level evidence-based medical evidence for precision risk stratification of prostate cancer.

 

Anna Wilkins教授：先和大家说明大家最关心的安全性问题：MMAI检测在临床应用中，不存在额外的安全风险与安全顾虑。原因非常明确：这项检测的唯一输入材料，是患者前列腺穿刺或术后病理诊断环节，已经常规制备完成的H&E染色病理切片，无需对患者进行额外的有创操作，无需额外获取组织样本，仅需对已有的病理切片进行数字化扫描即可完成全流程检测，全程不会给患者增加任何身体负担与诊疗风险，安全性完全可控。

 

而在临床实践层面，MMAI检测的核心价值，是为局限性前列腺癌的个体化治疗决策，提供了关键的精准分层依据，尤其解决了临床中长期存在的“治疗方案不确定性”的核心痛点，主要体现在两个方向：

 

第一，针对低风险人群，助力治疗降阶梯，避免过度治疗。对于MMAI评估为低风险的患者，该模型可以辅助临床精准筛选出适合降阶梯治疗的人群，让这部分患者有望豁免不必要的雄激素剥夺治疗（ADT），甚至可以为患者选择主动监测策略提供更充分的循证支持，在有效控制肿瘤进展风险的同时，最大程度保留患者的生活质量。

 

第二，针对高风险人群，提示治疗强化，改善远期生存。对于MMAI评估为高风险的患者，我们的研究数据明确提示，这类人群的复发转移风险显著更高，需要接受强化治疗方案，临床可在放疗的基础上联用新型全身治疗药物，通过更积极的干预降低疾病进展风险，最终改善患者的远期生存结局。

 

Oncology Frontier:Thank you for your detailed interpretation.Based on the results of this study，what core changes do you think it will bring to the clinical practice of prostate cancer?Meanwhile，what is the safety profile of this MMAI assay in clinical application?

 

Dr.Anna Wilkins:Let me first address the most concerning safety issue:there is no additional safety risk or concern associated with the clinical application of the MMAI assay.The reason is very clear:the only input material for this assay is the routinely prepared H&E stained pathological slides obtained from patients’prostate biopsy or postoperative pathological diagnosis procedures.No additional invasive procedures are required for patients，no additional tissue samples need to be collected，and the entire assay workflow can be completed only by digital scanning of the existing pathological slides.The whole process does not impose any physical burden or diagnostic and treatment risk on patients，with fully controllable safety.

 

At the clinical practice level，the core value of the MMAI assay is to provide key precision stratification basis for individualized treatment decision-making for localized prostate cancer，especially solving the long-standing core pain point of"uncertainty in treatment regimens"in clinical practice，which is mainly reflected in two directions:

 

First，for low-risk populations，it facilitates therapy de-escalation and avoids overtreatment.For patients assessed as low-risk by MMAI，the model can assist clinicians in accurately identifying populations suitable for de-escalated therapy，enabling these patients to potentially be spared unnecessary Androgen Deprivation Therapy(ADT)，and even providing more sufficient evidence-based support for patients choosing active surveillance strategies.While effectively controlling the risk of tumor progression，it maximally preserves patients’quality of life.

 

Second，for high-risk populations，it indicates the need for treatment intensification to improve long-term survival.For patients assessed as high-risk by MMAI，our study data clearly confirm that this population has a significantly higher risk of recurrence and metastasis，and requires intensified treatment regimens.Clinicians can combine novel systemic therapeutic agents on the basis of radiotherapy，and reduce the risk of disease progression through more aggressive interventions，ultimately improving the long-term survival outcomes of patients.

Anna Wilkins教授：这是一个非常贴合临床实际的关键问题。MMAI检测确实有很多适配临床常规流程的实用优势，但它的落地应用，高度依赖病理科数字扫描仪的硬件配置，以及高质量数字化病理切片的标准化制备能力。

 

目前，数字病理设备与标准化数字切片制备流程，在英国的覆盖范围正在逐步扩大，但尚未实现全国各级医疗机构的全面普及；在全球范围内，不同国家、不同地区的数字病理建设水平差异更大，这也是这项AI检测技术想要实现广泛临床应用，目前面临的最核心的现实挑战。

 

Oncology Frontier:We understand that the MMAI assay has many clinical advantages such as convenience，non-invasiveness，and excellent predictive performance.In your opinion，what are the core challenges currently faced by this technology to achieve wider global clinical popularization，and what implementation gaps need to be filled urgently?

 

Dr.Anna Wilkins:This is a key question that is very close to clinical reality.The MMAI assay does have many practical advantages adapted to routine clinical workflows，but its implementation is highly dependent on the hardware configuration of digital scanners in the pathology department，as well as the standardized preparation capacity of high-quality digital pathological slides.

 

At present，the coverage of digital pathology equipment and standardized digital slide preparation workflows is gradually expanding in the UK，but has not yet achieved full popularization across medical institutions at all levels nationwide.Globally，there are even greater differences in the development level of digital pathology between different countries and regions，which is the most core practical challenge currently faced by this AI assay technology to achieve extensive clinical application.

 

Anna Wilkins教授：本次大会发布的多项研究都极具突破性，其中我个人认为最值得临床关注的，是肌层浸润性膀胱癌领域的两项核心进展。

 

第一，膀胱癌新辅助治疗迎来了全新的标准治疗方案。本次大会公布的研究数据清晰证实，维恩妥尤单抗（EV，靶向Nectin-4的抗体偶联药物）联合帕博利珠单抗的新辅助治疗方案，是目前肌层浸润性膀胱癌领域，循证证据最充分、疗效最优的新辅助治疗方案，该方案正在快速成为该类患者的临床标准治疗。

 

第二，基因组生物标志物在膀胱癌精准诊疗中的价值得到进一步夯实。本次大会发布的多项最新研究数据，以非常高质量的循证证据，印证了基因组生物标志物在局限性膀胱癌全流程管理中的临床应用价值——通过生物标志物的精准分层，临床可以为不同风险、不同分子特征的膀胱癌患者，制定更个体化的治疗决策，真正推动膀胱癌精准诊疗的全面落地。

 

Oncology Frontier:At this ASCO GU congress，a large number of cutting-edge studies related to AI and genitourinary oncology have been presented.In your opinion，what other contents deserve key attention from clinicians and have important guiding value for daily clinical practice?

 

Dr.Anna Wilkins:A number of studies presented at this congress are highly groundbreaking.Among them，I personally believe that the two core advances in the field of muscle-invasive bladder cancer(MIBC)are most worthy of clinical attention.

 

First，a new standard of care has emerged for neoadjuvant therapy of bladder cancer.The study data presented at this congress clearly confirmed that the neoadjuvant regimen of Enfortumab Vedotin(EV，a Nectin-4-targeted antibody-drug conjugate[ADC])combined with pembrolizumab(a programmed cell death protein 1[PD-1]inhibitor)is currently the neoadjuvant treatment regimen with the most sufficient evidence-based evidence and optimal efficacy in the field of MIBC，and is rapidly becoming the clinical standard of care for these patients.

 

Second，the value of genomic biomarkers in the precision diagnosis and treatment of bladder cancer has been further consolidated.Multiple latest study data released at this congress，with high-quality evidence-based evidence，confirmed the clinical application value of genomic biomarkers in the full-cycle management of localized bladder cancer.Through precise stratification by biomarkers，clinicians can develop more individualized treatment decisions for bladder cancer patients with different risks and molecular characteristics，truly promoting the comprehensive implementation of precision diagnosis and treatment for bladder cancer.

 

Anna Wilkins教授

Anna Wilkins教授是伦敦癌症研究所的临床科学家，同时也是皇家马斯登医院的荣誉临床肿瘤顾问

她主要运用药物和放射疗法治疗前列腺癌和膀胱癌。研究结合了转化医学和临床前模型，旨在探究肿瘤微环境的不同特征（包括非癌细胞）如何帮助膀胱肿瘤在放射治疗后存活。现在领导着基质放射生物学研究组，该研究组致力于研究放射疗法和药物对肿瘤微环境各个方面的影响。最近获得了英国癌症研究中心（CRUK）临床科学家奖学金，以继续开展研究。