NCT03702439已完成不适用
Prostate Cancer Screening Trial Using A Group of Radiological Approaches Including MRI and Ultrasound
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater
研究概览
简要总结
Participants will be recruited from the community and attend a screening clinic and undergo the following screening tests:
- Bi-parametric MRI - reported by a radiologist and CAD-AI system
- Multiparametric ultrasound - including shearwave elastography
- A standard-of-care PSA test
A systematic +/- targeted biopsy will be performed if any tests are positive, independent of the other tests.
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
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged between 50 and 69 years inclusive at the time of study entry
- •Participants must be fit to undergo all procedures listed in the protocol
- •Estimated life expectancy of 10 years or more
- •An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
- •Participants must be willing and able to provide written informed consent
排除标准
- •Previous PSA test or prostate MRI within the prior two years of screening/consent visit
- •Evidence of a urinary tract infection or history of acute prostatitis within the last 6 months
- •Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer
- •Any potential contraindication to MRI
- •Any potential contraindication to prostate biopsy
- •Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
- •Any other medical condition precluding procedures described in the protocol
结局指标
主要结局
The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater
时间窗: Through study completion, an average of 1 month
Men with a positive MRI defined by a score of 3 or greater
次要结局
- The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater(Through study completion, an average of 1 month)
- The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater(Through study completion, an average of 1 month)
- The Proportion of Men With Screen-positive Prostate US Defined by a Score of 4 or Greater(Through study completion, an average of 1 month)
- The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml(Through study completion, an average of 1 month)
研究者
研究点 (1)
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