Prostate Cancer Screening With PSA, Risk Calculator and Multiparametric MRI: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 4,500
- 试验地点
- 1
- 主要终点
- Detection rate of clinically significant prostate cancer (Gleason Group ≥2)
研究概览
简要总结
Prostate Cancer (PCa) is the second most frequently diagnosed tumour and the third most lethal among men in Europe. The lack of precise tools and examinations to precisely diagnose PCa has caused overtreatment of indolent and low-aggressive PCa, while in some other cases, with aggressive disease, diagnosis and treatment are dangerously delayed because cancer could be potentially missed. The present trial aims to study a new pathway to early diagnose PCa with Magnetic Resonance Imaging (MRI) to identify men who will not need treatment and those who will benefit from radical treatment, thus improving disease control and quality of life.
详细描述
Men aged 55-65 years with neither previous biopsy nor prostate diseases will be invited in the screening protocol and will perform an initial PSA test. Those cases with PSA ≥ 3 ng/ml will be invited to undergo a urologic examination with computed risk assessment and an MRI, which is a non-invasive test with high positive and negative predictive value in identifying clinically significant prostate cancer. Then, only men with medium-high risk of harbouring clinically significant prostate cancer will be invited to undergo a prostate biopsy to indentify cancer presence and its aggressiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age between 55-65 years;
- •asymptomatic or paucisymptomatic from a urological point of view;
- •no previous prostate biopsy;
- •living in the ASL TO5 (Piedmont, Italy);
- •signed written informed consent.
排除标准
- •positive oncologic anamnesis for prostate cancer;
- •previous biopsy or prostate surgery;
- •previous radiotherapy of the pelvis;
- •any contraindication to MRI examination;
- •claustrophobic or uncollaborative subjects.
研究组 & 干预措施
Subjects with PSA ≥ 3 ng/ml
- Urologic examination
- Risk calculation (ERSPC no.6)
- Magnetic resonance imaging
- (optional) biopsy
干预措施: Urology visit with Risk Calculator and MRI (Diagnostic Test)
结局指标
主要结局
Detection rate of clinically significant prostate cancer (Gleason Group ≥2)
时间窗: 24 months
No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial
Comparison of the detection rate of clinically significant prostate cancer with and without screening
时间窗: 24 months
No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial compared to the same proportion of men calculated in the 2-year period before the introduction of the screening protocol
Verify that the detection rate of clinically significant prostate cancer with the screening strategy is not inferior to that of the Italian cohort in the ERSPC study
时间窗: 24 months
No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial compared to the same proportion of men included in the Italian cohort of the ERSPC study screened using PSA only
次要结局
- Changes in number of biopsy procedures(24 months)
- Assessment of positive and negative predictive values(24 months)