权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Biomarker Approaches to Individualizing Systemic Therapy for High Risk Prostate Cancer

高危前列腺癌个体化系统治疗的生物标志物方法

基本信息

批准号：
10310721
负责人：
Felix Yi-Chung Feng
金额：
$ 7.18万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-01 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10310721
关键词：
Address African African American Androgens Biological Markers CLIA certified Cancer Patient Cardiovascular system Clinical Clinical Research Cost Effectiveness Analysis Data Decision Analysis Decision Making Diagnosis Disease Disease Management Effectiveness European Event Exclusion Exposure to External Beam Radiation Therapy Fracture Future Gene Expression Profile Genomics Gleason Grade for Prostate Cancer Goals Grant Guidelines Health Benefit Impaired cognition Intervention Malignant Neoplasms Malignant neoplasm of prostate Mental Depression National Comprehensive Cancer Network Oligonucleotide Microarrays Operative Surgical Procedures Outcome Parents Pathologic Patients Performance Phase Population Prognosis Prognostic Marker Prostate Prostate-Specific Antigen Publishing Race Racial Equity Radiation Therapy Oncology Group Radiation therapy Recommendation Recurrence Risk Role Sampling Selection Criteria Sexual Dysfunction Systemic Therapy Therapeutic Tissues Toxic effect Tumor stage Use Effectiveness androgen deprivation therapy arm base biomarker panel cancer health disparity chemotherapy clinical predictors clinical translation cohort cost cost effective cost effectiveness density deprivation genetic signature genomic signature health equity high risk hormone therapy improved innovation lens markov model men molecular marker new therapeutic target novel parent grant personalized medicine phase III trial predicting response predictive marker predictive modeling predictive signature prognostic prognostic performance prognostic signature prognostic tool prognostic value prostate cancer risk randomized trial research clinical testing response risk stratification side effect specific biomarkers standard of care therapy duration tool treatment strategy tumor

项目摘要

PROJECT SUMMARY Despite the advancement of risk stratification tools on disease management for men with prostate cancer (PCa), there is still a paucity of prognostic tools aimed at identifying African American men (AAM) at increased risk for lethal prostate cancer in the setting of radiation therapy (RT) and androgen deprivation hormone therapy (ADT). Prognostic biomarker panels, such as Decipher, which have been developed and validated in surgical cohorts, have not been systematically validated for prognostic performance after RT+ADT. Furthermore, the cohorts used to derive and validate these prognostic tools have been, on the whole, made up of European-descendent patients. This has limited the prognostic ability in patients of African-descent, who have been shown to have worse prostate cancer-specific outcomes based on clinicopathologic factors including prostate-specific antigen (PSA), Gleason score, and tumor stage. Prognostic tools have not been developed with a racial equity lens, and the role of race and ancestry have only been an afterthought in the treatment recommendation guidelines resulting from Eurocentrically derived clinical studies. As of yet, race has remained on the sidelines without contributing in a clinically meaningful way to the identification, prognosis, treatment recommendations, and cost- effectiveness analysis for men of African-descent. This has limited our ability to identify non-white men at increased risk for lethal PCa, making treatment intensification less precise, limiting the effectiveness of more intense treatment interventions, and contributing to the widening of existing disparities. To address the lack of routine use of molecular biomarkers for therapeutic decision making in men with high-risk PCa, treated with definitive RT, the parent grant proposes to “develop and validate clinically useful and cost-effective prognostic and predictive biomarkers for high-risk PCa patients treated with RT.” This supplement seeks to expand the parent grant, by utilizing principles of health equity, to extend the reach of the findings beyond the traditional Eurocentric population, and in doing so improve the generalizability of the R01 findings to include AAM. This will be accomplished by: (1) comparing the clinical performance of the best prognostic signature and subsequent best prognostic tool, derived from integration of the genomic and clinicopathologic data, from parent grant Aim 1, between AAM and White men (WM) with PCa treated with RT, and (2) determine whether biomarker-based assignment to short-term ADT (STADT) vs. long-term ADT (LTADT) vs. LTADT+intensification, is cost-effective in AAM compared to WM with high-risk PCa, from parent grant Aim 3. Successful completion of this supplement will expand the findings of the parent R01 grant to focus specifically at AAM. Extending the reach of the findings beyond the traditional Eurocentric population.

项目总结