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: 10263282
• 负责人: Adam Bryant Murphy
• 金额: $ 59.43万
• 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/10263282
• 关键词: Address; Age; Asians; Biological Assay; Biological Markers; Biopsy; Clinical; Complication; Cost Analysis; Cost Effectiveness Analysis; Cost Measures; Data; Detection; Diagnosis; Diagnostic tests; Enrollment; Europe; Extracapsular; Gleason Grade for Prostate Cancer; Goals; Health; Hispanics; Histology; Image; Information Systems; Lesion; Lymphovascular; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Methods; Minority; Minority Groups; 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; digital; ethnic minority population; 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.

项目总结 原理：PSA筛查可发现太多低风险前列腺癌(PCAS)，并使太多男性 前列腺活检(PB)。因此，需要对侵袭性前列腺癌进行具有更高特异性的新的诊断试验。 前列腺健康指数(PHI)测量了3种激肽释放酶亚型，并已在#年的多个队列中得到验证 欧洲和美国用于预测PB的格里森分级≥3+4临床意义(Cs)Pca。这项测试可能 防止30%-58%的不必要的PBS，代价是推迟或漏检极少数高级PC。16- 18多参数前列腺磁共振成像(MP-MRI)同样有望检测格里森≥3+4 PCa8、18、19 英国的PROMIS研究使不必要的PBS减少了27%，几乎没有漏诊的癌症。 然而，这两种测试的特异性都很低，仍然使超过一半的男性患上了不必要的PB。此外，有有限的 在黑人男性中验证，在西班牙裔中几乎没有验证，因此排除了有意义的估计 在高风险和不断增长的人口中预测的准确性。18我们的长期目标是经济高效地 减少PCA过度检测和不必要的前列腺活检。 简介：Aim 1是一项观察性研究，旨在确定PHI和MRI单独使用的有效阈值 用于检测csPCA的串联(即PHI+/-MP-MRI和MP-MRI+/-PHI)或并行(PHI&MRI)。目标2是一项研究 根据种族来确定最具成本效益的策略。AIM 3将评估MRI漏掉的csPCA 通过仔细的病理检查和在MP-MRI上突出遗漏的csPCA以确定是否 确实没有出现在核磁共振上。所有地区都将获得PIRADS分数。MRI上看不到的csPCa将 以Gleason分级、肿瘤大小和包膜外侵犯为特征。我们还将寻找其他 侵袭性特征，如粉刺坏死、筛状组织学、导管内癌、神经内分泌 分化，淋巴血管和神经周围侵犯。我们将通过以下几个方面实现这些目标 具体目标： 1)单独、串联和并行使用PHI和MRI确定具有最高特异性的活检策略 为了最大限度地检测出具有临床意义的前列腺癌以进行活检-天真的黑人和西班牙裔 男人； 2a)比较首次活检时检测格里森≥3+4Pca的活检策略的成本； 2B)估计每种策略相对于所有男性活组织检查的成本效益，作为每格里森的成本 检测到≥3+4Pca； 3)描述接受根治性前列腺切除术的黑人和西班牙裔男性的MRI盲区。