Centre for Medical Imaging, University College London, London, UK
Centre for Medical Imaging, University College London, London, UK.
BMJ Open. 2022 Apr 8;12(4):e059847. doi: 10.1136/bmjopen-2021-059847.
Multiparametric MRI (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. However, the technique has modest specificity and a high false-positive rate, especially in men with mpMRI scored as indeterminate (3/5) or likely (4/5) to have clinically significant cancer (csPCa) (Gleason ≥3+4). Advanced MRI techniques have emerged which seek to improve this characterisation and could predict biopsy results non-invasively. Before these techniques are translated clinically, robust histological and clinical validation is required.
This study aims to clinically validate two advanced MRI techniques in a prospectively recruited cohort of men suspected of prostate cancer. Histological analysis of men undergoing biopsy or prostatectomy will be used for biological validation of biomarkers derived from Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours and Luminal Water imaging. In particular, prostatectomy specimens will be processed using three-dimension printed patient-specific moulds to allow for accurate MRI and histology mapping. The index tests will be compared with the histological reference standard to derive false positive rate and true positive rate for men with mpMRI scores which are indeterminate (3/5) or likely (4/5) to have clinically significant prostate cancer (csPCa). Histopathological validation from both biopsy and prostatectomy samples will provide the best ground truth in validating promising MRI techniques which could predict biopsy results and help avoid unnecessary biopsies in men suspected of prostate cancer.
Ethical approval was granted by the London-Queen Square Research Ethics Committee (19/LO/1803) on 23 January 2020. Results from the study will be presented at conferences and submitted to peer-reviewed journals for publication. Results will also be available on ClinicalTrials.gov.
NCT04792138.
多参数磁共振成像（mpMRI）目前广泛用于对疑似前列腺癌患者进行风险分层，并识别可疑的活检区域。然而，该技术的特异性不高，假阳性率较高，尤其是在 mpMRI 评分不确定（3/5）或可能（4/5）存在临床显著癌症（csPCa）（Gleason≥3+4）的患者中。一些先进的 MRI 技术已经出现，这些技术旨在改善这种特征，并能对活检结果进行非侵入性预测。在这些技术被临床应用之前，需要进行稳健的组织学和临床验证。
本研究旨在前瞻性招募疑似前列腺癌患者队列中对两种先进的 MRI 技术进行临床验证。对接受活检或前列腺切除术的患者进行组织学分析，用于对基于血管和细胞外限制扩散的细胞术的生物标志物和管腔水成像进行生物学验证。特别是，前列腺切除术标本将使用三维打印的患者特异性模具进行处理，以实现 MRI 和组织学的精确映射。将对指数检验与组织学参考标准进行比较，以得出 mpMRI 评分不确定（3/5）或可能（4/5）的患者的假阳性率和真阳性率，这些患者存在临床显著前列腺癌（csPCa）。活检和前列腺切除术样本的组织病理学验证将为验证有前途的 MRI 技术提供最佳的真实信息，这些技术可以预测活检结果，并有助于避免疑似前列腺癌患者进行不必要的活检。
伦敦-皇后广场研究伦理委员会于 2020 年 1 月 23 日批准了该研究的伦理申请（19/LO/1803）。研究结果将在会议上展示，并提交给同行评议的期刊发表。结果也将在 ClinicalTrials.gov 上公布。
NCT04792138。
