ProstaPilot: Prostate Cancer Screening Using MRI With an Abbreviated Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Proportion of positive PI-RADS detections in the cohort of patients indicated for biopsy.
研究概览
简要总结
Prostate cancer is one of the most common malignancies in the male population with incidence and mortality rates comparable to breast cancer in women, but in contrast, a population screening program that would fulfill all the recommended criteria is not yet available. According to international recommendations, the preventive PSA sampling used in clinical practice is not suitable because of the concurrent detection of clinically insignificant carcinomas in a major proportion of tests. These clinically non-significant cancers make up a significant and increasing proportion with age. Detection of non-significant cancers burdens the health care system and patients with the care that has no positive impact on their health. Current preventive serum prostate-specific antigen (PSA) testing does not distinguish benign hyperplasia and nonsignificant carcinoma from clinically significant cancer. It is therefore not suitable for full-scale screening.
According to current guidelines, magnetic resonance imaging (MRI) is indicated only in patients with an increased risk of cancer for detection or staging after biopsy and is not used for screening. According to recent studies, MRI has detected an increased proportion of significant cancers in the general population compared to screening based on PSA, while fewer clinically insignificant cancers have been detected. In screening, a shorter examination protocol without contrast medium (biparametric MRI) is used with a lower cost per examination, allowing to increase both the number of patients examined and patient comfort.
The main objective of the project is to assess the contribution of imaging in the screening of clinically significant prostate cancer and to validate the published results in the Czech population, and extend the screening model by the second round of examinations and additional laboratory markers. The secondary aim is to design a subsequent study with a larger number of participants allowing statistical evaluation, similar to the successful breast cancer screening.
详细描述
A prospective cross-sectional (with a longitudinal component, 2nd screening round) study evaluating the possibility of using the biparametric MRI protocol technique for screening clinically significant prostate cancer in men from the general population.
Tests performed:
- Serum PSA
- PHI calculation (Prostate Health Index) to be performed only if the PSA values are in the range of 2-10 ng/l
- MRI of the prostate (abbreviated biparametric protocol)
- Digital rectal examination (DRE) as part of a clinical visit at a urologist in patients with a positive PSA test
- Biopsy - if indicated
MRI specifications:
- Protocol with anatomical T2 sequence and diffusion-weighted images (DWI), according to the standards
- Typical complete examination time does not exceed 20 minutes, planned acquisition time less than 15 minutes.
- No contrast agent or spasmolytics is injected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 50-69 years
- •Life expectancy over 10 years
- •Ability to undergo all planned procedures (without contraindications to MRI or biopsy)
- •No known prostate cancer or prostate biopsy in the past (interventions for BPH are not a restriction)
- •No PSA test or prostate MRI in the past 2 years.
- •No signs of prostatitis or urinary tract infection in the past 6 months.
- •Signed informed consent.
排除标准
- •Contraindications to MRI
- •Hip replacement
- •Known BRCA1/BRCA2 mutation
结局指标
主要结局
Proportion of positive PI-RADS detections in the cohort of patients indicated for biopsy.
时间窗: 2 years
Ratio of significant and non-significant cancers in individual categories of PI-RADS scores in patients indicated for biopsy.
Assessment of the importance of the imaging test in the screening of significant prostate cancer in asymptomatic men, compared with PSA screening: Proportion of positive MRI findings
时间窗: 2 years
Proportion of positive MRI findings (PI-RADS 4+) in the general population of men aged 50-69 years.
Distribution of PI-RADS scores in the observed cohort.
时间窗: 2 years
Distribution of PI-RADS scores (proportion of individual scores 1-5) in the screened population.
次要结局
- Feasibility evaluation of a larger-scale study of screening for significant prostate cancer using an imaging modality:(2 years)
- Patient adherence to preventive examination.(2 years)
- Evaluation of patient adherence to preventive examination.(2 years)
- Evaluation of complications after an interventional procedure (biopsy).(2 years)
- Patient adherence to preventive examination - self-recruitment.(2 years)
- Evaluation of patient adherence to preventive examination - active recruitment.(2 years)
- Evaluation of patient adherence to preventive examination - completation of planned exams.(2 years)
- Evaluation of the financial burden of the study for the future preventive program of prostate cancer screening.(2 years)
- Detection and assessment of potential barriers to patient participation in the study. Assessment of patient adherence to remain in the study throughout the study period.(2 years)