A Randomized Controlled Trial on the Role of Magnetic Resonance Imaging for Prostate Cancer Screening
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 710
- 试验地点
- 2
- 主要终点
- Diagnosis of prostate cancer with non-contrast MRI
研究概览
简要总结
Prostate Cancer (PCa) screening is still a controversial topic in the urology community, this is mostly linked to the low specificity of Prostate Specific Antigen (PSA) value. Screening with total PSA value has cause overdiagnosis of clinically insignificant prostate cancer (ciPCa) for many years, with lack of survival improvement. Non-contrast MRI, on the other hand, has become one of the most promising MRI applications, as it is a more sensitive test able to perform clinically significant PCa early detection. With this background the primary endpoint was to investigate the role of non-contrast MRI (without injection of paramagnetic contrast medium), as a secondary prevention test for the early diagnosis of prostate cancer, comparing it with the serum PSA test, in a randomized fashion.
详细描述
ENDPOINTS Primary endpoint To investigate the role of non-contrast Magnetic Resonance Imaging (MRI), as a secondary prevention test for the early diagnosis of prostate cancer (PCa), comparing it with the serum PSA test.
Secondary endpoints
- Assess the percentage of men with a positive PSA screening test, defined as > 4 ng/ml and > 2.5 ng/ml in patients with family history of PCa (father and/or sibling).
- Evaluation of the percentage of men with positive MRI and MRI targeted biopsy results stratified according to: absence of neoplasm, non-clinically significant neoplasm (ISUP 1) and clinically significant neoplasm (ISUP> 1), compared with PSA test and serum biomarkers (optional).
- Comparison of the percentages of participants with PCa and with clinically significant PCa, according to the different positive screening tests.
- Comparison of the different screening tests combinations in terms of PCa detection rate, both for non-clinically significant and clinically significant cancer.
STUDY DESIGN
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •Males aged between 49-69 years (from the age of 40 for those with family history of prostate cancer) at the time of enrollment
- •Life expectancy greater than or equal to 10 years
- •Sufficient understanding of the Italian language for written and verbal understanding of the information for enrollment in the Trial and for the process of obtaining informed consent.
- •Patient with the ability to understand and want, able to express informed consent and to perform all the visits and procedures required by the study
排除标准
- •General contraindications to MRI
- •Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer
- •Any contraindications to prostate biopsy, such as severe coagulation abnormalities (INR> 1.5), active urinary tract infection and acute prostatitis (NIH category I, II and III).
- •Dementia or altered mental status that would prohibit understanding or granting informed consent
结局指标
主要结局
Diagnosis of prostate cancer with non-contrast MRI
时间窗: 24 months
To investigate the role of MRI with a bi-parametric approach (without injection of paramagnetic contrast medium), as a secondary prevention test for the early diagnosis of prostate cancer, comparing it with the serum PSA test.
次要结局
- Percentage of men with a positive PSA screening test(2 years)
研究者
Valeria Panebianco
Professor of Radiology
University of Roma La Sapienza