Evaluation of the PROSTia Test in Patients Undergoing Prostate Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- sensitivity
研究概览
简要总结
The investigators are interested here in the contribution of a new prostate cancer screening method and, more specifically, in the new and somewhat futuristic approach of artificial intelligence in the development of new, more accurate algorithms that make it possible to rethink the benefits of mass generalisation of prostate biopsies.
Main objective The main objective of this research is to use artificial intelligence and an associated algorithm to identify new indicators that would make it possible to avoid a prostate biopsy in patients with an initial suspicion of prostate cancer.
详细描述
.1. Outline of the study The lack of accuracy of the PSA test for prostate cancer screening leads to negative biopsies. The aim of this study is to determine whether the PROSTia test, a personalised medicine test using artificial intelligence (AI) by combining PSA, digital rectal examination (DRE) and 60 other qualitative data, could reduce the number of unnecessary biopsies and to estimate its impact on the detection of clinically significant cancers.
PROSTia employs the Gradient Boosting technique to select the variables of interest and optimise model performance. This process entails the utilisation of successive decision trees to model the non-linear relationships between the input variables and cancer risk. The construction of each tree is predicated on the correction of errors identified in preceding trees, with a focus on cases that have been misclassified. This iterative process is instrumental in generating a robust and accurate model for the purpose of prostate cancer screening
2 Methodology
The result of the PROSTia test is a score on a scale of 0 to 2. A score greater than or equal to 1 is considered a positive result. A positive result means that the patient has a significant risk of developing prostate cancer in the next 12 years. The following statistical analyses are performed using a 95% confidence interval:
- Sensitivity
- Specificity
- Positive likelihood ratio
- Negative likelihood ratio
- Disease prevalence
- Positive predictive value
- Negative predictive value
- Accuracy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients followed up at the Nancy CHRU in the Urology Department and eligible for a prostate biopsy in search of prostate cancer, taking into account an increase in PSA, PSA density, lesion on MRI.
- •Person who has received full information about the organisation of the research and has not objected to their participation and the use of their data.
- •Adult male over 18 years of age - Patient affiliated to or benefiting from a social security scheme - Patient who understands French and is able to fill in a self-administered questionnaire or who has the possibility to be assisted in filling it in.
排除标准
- •Patients who have already had a prostate biopsy
- •Patients under court protection, guardianship or trusteeship
- •Patients deprived of liberty by judicial or administrative decision
结局指标
主要结局
sensitivity
时间窗: Immediately after to notification of prostate biopsy results.
Measuring the sensitivity of the test in comparison with the results of prostate biopsies
specificity
时间窗: Immediately after to notification of prostate biopsy results.
Measuring the specificity of the test in comparison with the results of prostate biopsies
positive likehood ratio
时间窗: Immediately after to notification of prostate biopsy results.
Measuring the positive likehood ratio of the test in comparison with the results of prostate biopsies
negative likehood ratio
时间窗: Immediately after to notification of prostate biopsy results.
Measuring the negative likehood ratio of the test in comparison with the results of prostate biopsies
disease prevalence
时间窗: Immediately after to notification of prostate biopsy results.
Measuring the disease prevalence of the test in comparison with the results of prostate biopsies
positive predictive value
时间窗: Immediately after to notification of prostate biopsy results.
Measuring the positive predictive value with the results of prostate biopsies
negative predictive value
时间窗: Immediately after to notification of prostate biopsy results.
Measuring the negative predictive value with the results of prostate biopsies
accuracy
时间窗: Immediately after to notification of prostate biopsy results.
Measuring the accuracy of the test in comparison with the results of prostate biopsies
次要结局
- ability of the test to detect clinically significant cancers (ISUP ≥ 2)(Immediately after to notification of prostate biopsy results.)
- failure rate of the test to detect the most aggressive cancers (ISUP 4 and 5)(Immediately after to notification of prostate biopsy results.)
研究者
ESCHWEGE Pascal
Principal Investigator
Central Hospital, Nancy, France