A Multi-centre Validation Cohort Study Evaluating the Chemical Elements Content in Semen and Expressed Prostatic Secretions in the Diagnosis and Characterisation of Prostate Cancer, in Men Identified as Having a Risk of Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Threshold
研究概览
简要总结
A multi-site study to evaluate the potential use of the ChEC test of seminal fluid as an additional triage test in stratifying patients for further tests.
详细描述
A biomarker is a molecular substance that is an indicator of a biological condition. Cambridge Oncometrix believe that a semen biomarker may be able to predict the presence of prostate cancer. This study will allow work to be carried out on semen samples donated by men who have been identified by their GPs as having a risk of prostate cancer. Normally, GPs refer men with symptoms or a raised PSA to hospital to have an MRI scan and a biopsy.
The PLiS research team at the hospital will contact potential patients, who have been referred by their GPs, before they have an MRI or a biopsy, ask them if they are willing to take part in the study, consent them and ask them to provide a semen sample. Semen samples will be produced by the potential participants at home into a seminal fluid collection container, they will also have to complete a study questionnaire. Both the sample and the questionnaire will be returned to the central laboratory in Cambridge using the stamped addressed envelope provided.
In addition to providing a semen sample and completing a questionnaire, each participant will have two blood tests to measure male hormones. Participants then exit the trial and their usual care carries on from this point. The PLiS study will register 400 men and of those it is hoped that 300 of them will be able to provide semen.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men over 40 years old with suspected prostate cancer who have been referred to a secondary care
- •Men able to produce a semen sample
- •Men able to have a prostate mpMRI
- •Men who have given their written informed consent
排除标准
- •Previous history of prostate biopsy
- •Contraindication to MRI
- •Previous history of prostate surgery
- •Treatment with 5-alpha-reductase inhibitors at time of registration or during the prior 6 months
- •Evidence of urinary tract infection or history of acute prostatitis within the last month
- •Androgen replacement therapy within the last 3 months
- •Any other medical condition precluding standard diagnostic workup and collection of semen samples.
结局指标
主要结局
Threshold
时间窗: 18 Months
Optimal threshold for the ChEC-S diagnostic score
Proportion
时间窗: 18 Months
Proportion of men who could safely avoid an MRI targeted biopsy as determined by specificity and negative predictive values of the ChEC-S test at the optimal ChEC-S test cut-off levels
Metrics of the ChEC-S test
时间窗: 18 Months
Sensitivity, specificity, negative and positive predictive values, and reciever operating characteristics (area under the curve) in the participants with a high risk of prostate cancer using mpMRI as a clinical reference standard.
次要结局
- Proportion of significance(18 Months)
- Hypogonadism Impact(18 Months)
- Value(18 Months)
- Resource(18 Months)