NCT06398639招募中不适用
Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 10
- 主要终点
- Risk Ratio - Three Age Groups
研究概览
简要总结
The goal of this clinical trial is to evaluate a screening method to detect clinically relevant prostate cancer. This clinical trial is using genetic data to determine a man's risk of cancer, together with multiparametric magnetic resonance imaging (mpMRI) to identify men with higher grade cancer.
The main questions it aims to answer are:
- If genetic data related to prostate cancer used with MRI can identify higher-grade, potentially fatal prostate cancer
- What age a MRI is useful clinically for prostate cancer screening
- If deep learning methods used with MRI when the genetic risk of the man is known can more accurately predict significant cancers
Participants will:
- Get a prostate specific antigen (PSA) blood test
- Get an mpMRI
- Get the results of their genetic data to determine if they are considered high-, intermediate-, or low-risk for prostate cancer based on the trials genetic testing
- Follow-up for this trial based on the participants risk and findings from the PSA test and mpMRI
详细描述
Background:
- Prostate cancer is the most commonly diagnosed cancer among men in the United States
- Prostate cancer screening using the marker prostate-specific antigen (PSA) is controversial
- PSA based screening is less effective, at least in part, because it rests on screening the entire population
- Polygenic risk scores stratify men based on their prostate cancer genetic predisposition and may improve population level screening programs by focusing on men with higher risk of disease and sparing low risk men
- It is critical that studies aiming to translate the development of an early-detection strategy are conducted within a diverse patient population to address prostate cancer mortality disparities
Study Design:
- Plan to accrue 1,500 participants from both established biobanks and primary care offices
- Participants will get an initial PSA screening blood test and an mpMRI
- Participants will have their polygenic risk score determined from genome-wide association study (GWAS) data
- Participant follow-up will be determined by PRS results, as well as if there are abnormal findings on their PSA screening and/or mpMRI
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •They must have the ability to understand and the willingness to sign a written information consent document.
- •Estimated life expectancy of greater than 10 years.
- •No history of prostate cancer.
- •Participants must be between 40-69 years of age. This is the age at which screening for prostate cancer is recommended. This is due to younger patients not being at risk for the disease and older patients not benefiting from diagnosis.
- •No biopsy for prostate cancer within the past 5 years.
- •No prostate MRI within the past 5 years.
排除标准
- •Unwillingness to sign the informed consent form.
- •Contraindication to biopsy such as uncorrectable bleeding or coagulation disorder.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
- •Unable to undergo an MRI.
结局指标
主要结局
Risk Ratio - Three Age Groups
时间窗: Through study completion, an average of 1 year.
The ratio between men with high PRS and intermediate PRS in each of the three age groups (40-54, 55-64, 65-69) regardless of their ethnicity.
次要结局
- Risk Ratio - Six Age Groups(Through study completion, an average of 1 year.)
- Rare Variants(Through study completion, an average of 1 year.)
研究者
Adam S. Kibel, MD
Chair, Department of Urology, Brigham Health & Dana-Farber Cancer Institute; DiNovi Family Distinguished Chair in Urology, Brigham and Women's Hospital; Elliott Carr Cutler Professor of Surgery, Harvard Medical School
Brigham and Women's Hospital
研究点 (10)
Loading locations...
相似试验
进行中（未招募）
不适用
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular HealthCoronary Artery DiseaseNCT05819814Massachusetts General Hospital200
招募中
不适用
The Genomic Medicine at VA StudyAtrial FibrillationCoronary Artery DiseaseBreast CancerProstate CancerColorectal CancerType 2 DiabetesNCT04331535Boston VA Research Institute, Inc.1,076
进行中（未招募）
4 期
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and ColchicineCoronary Artery DiseaseNCT05850091Massachusetts General Hospital200
已完成
不适用
Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk ScoringCoronary Artery DiseaseNCT04604353Baker Heart and Diabetes Institute1,059
进行中（未招募）
不适用
A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary NodulesPulmonary NoduleNCT06074133Vanderbilt-Ingram Cancer Center103