Using Prostate Health Index and MRI in Combination for Cost-effectively Detecting High-Grade Prostate Cancer in Minorities

结合使用前列腺健康指数和 MRI 来经济有效地检测少数族裔的高级别前列腺癌

• 批准号: 10435578
• 负责人: Adam Bryant Murphy
• 金额: $ 59.1万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-14 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10435578
• 关键词: Address; Age; Asian population; Biological Assay; Biological Markers; Biopsy; Black Populations; Black race; Clinical; Complication; Cost Analysis; Cost Effectiveness Analysis; Cost Measures; Data; Detection; Diagnosis; Diagnostic tests; Enrollment; Europe; Extracapsular; Gleason Grade for Prostate Cancer; Goals; Health; Hispanic; Hispanic Populations; Histology; Image; Information Systems; Lesion; Lymphovascular; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Methods; Minority; Minority Groups; Minority Men; Morbidity - disease rate; Noninfiltrating Intraductal Carcinoma; Observational Study; PSA screening; Pathologic; Pathologist; Population; Predictive Value; Prostate; Prostate-Specific Antigen; Protein Isoforms; Race; Radical Prostatectomy; Reporting; Safety; Screening for Prostate Cancer; Sensitivity and Specificity; Series; Specificity; Testing; Validation; black men; blind; cancer diagnosis; clinically significant; cohort; comparative effectiveness study; cost; cost effective; cost effectiveness; cost estimate; cost-effectiveness ratio; diagnostic strategy; digital; ethnic minority; experience; high risk; imaging modality; improved; incremental cost-effectiveness; indexing; innovation; male; men; neuroendocrine differentiation; noninvasive diagnosis; novel diagnostics; overtreatment; perineural; prevent; prospective; prostate biopsy; prostate cancer risk; recruit; rectal; safety assessment; standard of care; tool; tumor

PROJECT SUMMARY Rationale: PSA screening detects too many low risk prostate cancers (PCas) and subjects too many men to prostate biopsy (PB). Hence, new diagnostic tests with improved specificity for aggressive PCa are needed. Prostate Health Index (PHI) measures 3 kallikrein isoforms and has been validated in multiple cohorts in Europe and the US for prediction of Gleason grade ≥3+4 clinically significant (cs) PCa at PB. The test could prevent 30-58% of unnecessary PBs at a cost of deferring or missing detection of very few high-grade PCas.16- 18 Multi-parametric MRI of the prostate (MP-MRI) is similarly promising for detecting Gleason ≥3+4 PCa.8,18,19 The PROMIS study from the UK resulted in a 27% reduction in unnecessary PBs with few missed cancers.19 However, both tests low specificity still subjects over half of men to unnecessary PB. Moreover, there is limited validation in Black men and almost no validation in Hispanics, thus precluding meaningful estimates of predictive accuracy in a high-risk and a growing population.18 Our long-term goal is to cost-effectively reduce PCa over-detection and unnecessary prostate biopsies. Brief Description: Aim 1 is an observational study to identify effective thresholds of PHI and MRI used alone, in series (i.e. PHI +/- MP-MRI and MP-MRI+/-PHI) or in parallel (PHI & MRI) for detecting csPCa. Aim 2 is a study to determine the most cost-effective strategy by race. Aim 3 will assess the csPCas that were missed by MRI by careful pathologic review and highlighting the missed csPCa for corroboration on MP-MRI to see if they were truly not present on the MRI. All regions will be assigned a PIRADS Score. csPCas not seen on MRI will be characterized for Gleason grade, tumor size and extracapsular extension. We will also look for other aggressive features like comedonecrosis, cribriform histology, intraductal carcinoma, neuroendocrine differentiation, and lymphovascular and perineural invasion. We will address these objectives with the following Specific Aims: 1) Identify the biopsy strategies with highest specificity using PHI and MRI alone, in series, and in parallel to maximize the detection of clinically significant prostate cancer for biopsy-naïve Black and Hispanic men; 2A) Compare the costs of the biopsy strategies for the detection of Gleason ≥3+4 PCa at initial biopsy; 2B) Estimate the cost-effectiveness of each strategy relative to biopsying all men as the cost per Gleason ≥3+4 PCa detected; 3) Characterize the MRI-blind lesions in Blacks and Hispanics men undergoing radical prostatectomy.

项目摘要 理由：PSA筛查检测到太多的低风险前列腺癌（PCAS），受试者太多了 前列腺活检（PB）。因此，需要对具有侵略性PCA的特异性提高的新诊断测试。 前列腺健康指数（PHI）测量3 kallikrein同工型，并已在多个队列中进行了验证 欧洲和美国在PB时预测格里森级≥3+4临床意义（CS）PCA。测试可以 预防30-58％的不必要的PBS，以延期或缺少很少的高级PCA的损失。16-- 前列腺（MP-MRI）的18个多参数MRI同样有望检测格里森≥3+4 pca.8,18,19 来自英国的Promis研究导致不必要的PB降低了27％，几乎没有癌症。19 但是，这两种测试均均较低的特异性仍然受到一半以上男性的不必要的PB。而且，有限 黑人的验证，几乎没有西班牙裔验证，因此排除了有意义的估计 高风险和人口增长的预测准确性。18我们的长期目标是成本效益 减少PCA过度检测和不必要的前列腺活检。 简要说明：AIM 1是一项观察性研究，旨在确定单独使用的PHI和MRI的有效阈值， 用于检测CSPCA的系列（即PHI +/- MP-MRI和MP-MRI和MP-MRI +/- PHI）或并行（PHI＆MRI）。 AIM 2是一项研究 确定种族最具成本效益的策略。 AIM 3将评估MRI错过的CSPCA 通过仔细的病理审查并突出显示了错过的CSPCA以证实MP-MRI，以查看它们是否是否 MRI上确实不存在。所有区域将被分配为Pirads得分。在MRI上看不到的CSPCA 以格里森级，肿瘤大小和囊外延伸为特征。我们还将寻找其他 积极的特征，例如comenecrosis，Cribroloursoly组织学，导管内癌，神经内分泌 分化，淋巴和周围性侵袭。我们将通过以下内容解决这些对象 具体目的： 1）仅使用PHI和MRI，串联确定具有最高特异性的活检策略，并并行 为了最大程度地检测对活检的临床意义前列腺癌 - 没有黑色和西班牙裔 男人 2a）比较初始活检时检测格里森≥3+4 PCA的活检策略的成本； 2b）估计每种策略的成本效益相对于活检所有男人的成本效益 检测到≥3+4 PCA； 3）表征黑人和西班牙裔男子接受根治性前列腺切除术的MRI盲病变。