Danish Prostate Cancer Consortium Study-1 (DPCC-1): Multicenter Development of Liquid Biopsy Biomarkers for Early Detection of Prostate Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 3
- 主要终点
- Number of MRI scans used to detect clinically significant PCs.
研究概览
简要总结
The purpose of the study is to investigate if a new promising microRNA-based urine biomarker test for prostate cancer, called uCaP, is better than the current standard test (PSA) to identify men who would benefit from an MRI scan of the prostate. The study will include 2,500 men referred to MRI of the prostate at three major hospital centers in Denmark (Aarhus, Odense, and Herlev) and compare the accuracy of uCaP to PSA. Based on preliminary data it is expected that uCaP will be >20% better than PSA at identifying treatment-requiring cancer. Hence, uCaP could help to better pre-select men for MRI and thereby reduce unnecessary MRI scans, unnecessary prostate biopsies, as well as overdiagnosis and overtreatment of indolent PCs, while maintaining high sensitivity for aggressive PC that needs early detection and early treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Understand oral and written Danish.
- •Referred to MRI (multi or bi-parametric) due to suspicion of PC at AUH, OUH, or HGH.
排除标准
- •Previously diagnosed with PC or other urogenital cancers.
- •Has one or more contraindications for MRI.
- •Have had gender reassignment treatment.
- •Blood PSA levels > 20 μg/l.
结局指标
主要结局
Number of MRI scans used to detect clinically significant PCs.
时间窗: At recruitment completion, at year 3 in 2025
Compare the total number of MRI scans required to detect clinically significant PC in the study population for the uCaP score vs. PSA or a combination of uCaP+PSA vs. PSA alone.
Clinically significant PC diagnoses compared to benign biopsies.
时间窗: At recruitment completion, at year 3 in 2025
Compare the number of patients diagnosed with clinically significant PC compared to the number of patients with benign biopsies (no cancer; i.e. unnecessary biopsy) for the uCaP score vs. PSA or a combination of uCaP+PSA vs. PSA alone.
Clinically significant PC diagnoses compared to clinically insignificant PC diagnoses.
时间窗: At recruitment completion, at year 3 in 2025
Compare the number of men diagnosed with clinically significant PC with the number of men diagnosed with clinically insignificant PC (i.e. overdiagnosed) for the uCaP score vs. PSA or a combination of uCaP+PSA vs. PSA alone.
次要结局
未报告次要终点