Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,800
- 试验地点
- 5
- 主要终点
- Diagnostic Clinical Performance: prediction of clinically significant prostate cancer at biopsy
研究概览
简要总结
This ambispective observational cohort study will evaluate the clinical performance of the ClarityDX Prostate blood test in men with a prostate-specific antigen (PSA) level of 3 ng/mL or higher who are undergoing prostate biopsy due to suspicion of prostate cancer. The study will compare ClarityDX Prostate test results with biopsy outcomes to determine the test's ability to identify the presence of clinically significant prostate cancer.
详细描述
The main objective of this study is to validate ClarityDX Prostate as a reflex test to PSA to refine the prediction of clinically-significant prostate cancer in a prospective cohort of men to be recruited in North America when they are scheduled for a biopsy as a result of on an elevated PSA or other suspicion of prostate cancer and in retrospective databases from selected sites in the United States of America and the world.
The training and validation analysis sets will consist of up to 2,800 consenting men from Alberta in addition to up to 5,000 men from external institutions, between ages 40-75 (inclusive) years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males between 40-75 (inclusive) years of age;
- •With and without family history of prostate cancer;
- •No prior prostate cancer diagnosis and who are referred to have a prostate biopsy;
- •Total PSA results >/= 3ng/mL collected within 6m of enrollment;
- •Willing to permit provincial agencies (e.g. Alberta Health Services, Alberta Health, Netcare, Service Alberta or other based on recruitment jurisdiction) to disclose health-related information to study;
- •Undergoing a diagnostic prostate biopsy; and
- •Provided informed consent to participate in the study.
排除标准
- •Unwilling to participate in the study;
- •Unavailable for biopsy procedure in recruitment areas;
- •Not undergoing a prostate biopsy;
- •Prior diagnosis of cancer excluding non-melanoma skin cancer; and/or
- •Under the age of 40 years of age or over the age of 75 years of age.
结局指标
主要结局
Diagnostic Clinical Performance: prediction of clinically significant prostate cancer at biopsy
时间窗: 3 years
Training Phase: Processed clinical features of each patient will be analyzed using machine learning to predict clinically significant prostate cancer, with the output being the ClarityDX Prostate Risk Score. Validation Phase: The models created during the Training Phase will be locked down and then used to determine the probability of approximately 1,400 patients in the investigational Validation Phase having clinically significant prostate cancer.
Active Surveillance: prediction of Gleason Grade Group on confirmatory/follow-up biopsies for participants on Active Surveillance
时间窗: 4 years
MRI: prediction of PI-RADS pre-diagnostic biopsy
时间窗: 4 years
次要结局
- Health economics(3 years)
- Medication and co-morbidities(Baseline)
- Analytical validity of the ClarityDX Prostate test(1 year post enrollment)