UCL Division of Surgical & Interventional Sciences, University College London, London, United Kingdom.
Department of Urology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.
PLoS One. 2022 Feb 24;17(2):e0259672. doi: 10.1371/journal.pone.0259672. eCollection 2022.
The ReIMAGINE Consortium was conceived to develop risk-stratification models that might incorporate the full range of novel prostate cancer (PCa) diagnostics (both commercial and academic).
ReIMAGINE Risk is an ethics approved (19/LO/1128) multicentre, prospective, observational cohort study which will recruit 1000 treatment-naive men undergoing a multi-parametric MRI (mpMRI) due to an elevated PSA (≤20ng/ml) or abnormal prostate examination who subsequently had a suspicious mpMRI (score≥3, stage ≤T3bN0M0). Primary outcomes include the detection of ≥Gleason 7 PCa at baseline and time to clinical progression, metastasis and death. Baseline blood, urine, and biopsy cores for fresh prostate tissue samples (2 targeted and 1 non-targeted) will be biobanked for future analysis. High-resolution scanning of pathology whole-slide imaging and MRI-DICOM images will be collected. Consortium partners will be granted access to data and biobanks to develop and validate biomarkers using correlation to mpMRI, biopsy-based disease status and long-term clinical outcomes.
Recruitment began in September 2019(n = 533). A first site opened in September 2019 (n = 296), a second in November 2019 (n = 210) and a third in December 2020 (n = 27). Acceptance to the study has been 65% and a mean of 36.5ml(SD+/-10.0), 12.9ml(SD+/-3.7) and 2.8ml(SD+/-0.7) urine, plasma and serum donated for research, respectively. There are currently 4 academic and 15 commercial partners spanning imaging (9 radiomics, artificial intelligence/machine learning), fluidic (3 blood-based and 2urine-based) and tissue-based (1) biomarkers.
The consortium will develop, or adjust, risk models for PCa, and provide a platform for evaluating the role of novel diagnostics in the era of pre-biopsy MRI and targeted biopsy.
REIMAGINE 联盟的构想是开发风险分层模型，该模型可能包含新型前列腺癌（PCa）诊断的全部范围（商业和学术）。
REIMAGINE 风险是一项经过伦理批准（19/LO/1128）的多中心、前瞻性、观察性队列研究，将招募 1000 名接受多参数 MRI（mpMRI）检查的初治男性，这些男性的 PSA（≤20ng/ml）升高或前列腺检查异常，随后发现 mpMRI 可疑（评分≥3，分期≤T3bN0M0）。主要结局包括基线时≥Gleason 7 PCa 的检出率以及临床进展、转移和死亡的时间。将采集基线血液、尿液和活检芯，用于新鲜前列腺组织样本（2 个靶向和 1 个非靶向）的生物库，以备将来分析。将采集高分辨率病理全切片成像和 MRI-DICOM 图像扫描。联盟合作伙伴将被授予访问数据和生物库的权限，以开发和验证使用与 mpMRI、基于活检的疾病状态和长期临床结局相关联的生物标志物。
2019 年 9 月开始招募（n=533）。第一个站点于 2019 年 9 月开放（n=296），第二个于 2019 年 11 月开放（n=210），第三个于 2020 年 12 月开放（n=27）。研究的接受率为 65%，平均捐赠用于研究的尿液、血浆和血清分别为 36.5ml（SD+/-10.0）、12.9ml（SD+/-3.7）和 2.8ml（SD+/-0.7）。目前有 4 个学术和 15 个商业合作伙伴，涵盖成像（9 个放射组学、人工智能/机器学习）、流体（3 个血液和2 个尿液）和组织（1）生物标志物。
该联盟将开发或调整 PCa 的风险模型，并为在 MRI 引导下的靶向活检时代评估新型诊断方法的作用提供一个平台。
