A Study Assessing Whether Artificial Intelligence is Non-inferior to Radiologists in the Diagnosis of Clinically Significant Prostate Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Proportion of men with clinically significant cancer
研究概览
简要总结
Prostate cancer is the most common male cancer in 112 countries and makes up 7% of global cancer cases, and is the second leading cause of cancer-related deaths in men.
Normally, men with suspected prostate cancer undergo a prostate MRI, and then a Radiologist would review this scan to identify any suspicious areas for cancer within the prostate. Prostate MRI interpretation, however, is an expert skill with a steep learning curve, and internationally, there is a growing shortage of Radiologists.
The PARADIGM trial aims to assess if AI can perform just as well as Radiologists in interpreting prostate MRI scans to identify prostate cancer. Enrolled participants will undergo a prostate MRI, which is the normal method used for investigating suspected prostate cancer. AI and a Radiologist will both interpret the MRI, without knowledge of each other's interpretation. Once both reports have been made, the Radiologist will be asked to produce a third, combined report.
If there is a suspicious area in the prostate identified either by AI or the Radiologist, targeted biopsies will be performed. If there are no suspicious areas on the MRI and if you are at low risk of harbouring cancer, which occurs in about 30% of men, then no biopsy will be taken at all.
详细描述
Aim: To assess whether artificial intelligence is non-inferior to radiologists in the diagnosis of clinically significant prostate cancer on MRI.
Objectives
Primary
1. To compare the proportion of men who have clinically significant prostate cancer detected on MRI using AI ± targeted biopsy with radiologists ± targeted biopsy.
Secondary
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
- Single (Care Provider)
盲法说明
AI and Radiologist interpreting the MRI for suspicion of prostate cancer are blinded to each other. After both reports are produced, they are unblinded, and a merged report is produced. All bioopsies are conducted as a result of both the AI and Radiologist interpretation, and as a result, lesions will be identified as AI and Radiologist positive, or negative, as appropriate. Diagnostic accuracy will be assessed against histology findings.
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
- •Men at least 18 years of age referred with clinical suspicion of prostate cancer
- •Serum PSA ≤ 20 ng/mL
- •Fit to undergo all procedures listed in the protocol
- •Able to provide written informed consent
排除标准
- •Prior prostate biopsy
- •Prior prostate MRI on a previous encounter*
- •Prior treatment for prostate cancer
- •Contraindication to MRI (e.g. claustrophobia, pacemaker)
- •Metalwork that would give rise to artefact on MRI (e.g. hip prosthesis, pelvic/spinal metalwork)
- •Contraindication to prostate biopsy
- •Unfit to undergo any procedures listed in protocol
- •An MRI on a previous encounter means a previous prostate MRI which has been seen by a doctor and has been used to inform patient management at the time of the original MRI.
研究组 & 干预措施
Radiologist interpretation of MRI +/- prostate biopsy
Radiologist Interpretation
干预措施: Radiologist interpretation (Diagnostic Test)
AI interpretation of MRI +/- prostate biopsy
AI Interpretation
干预措施: AI (Lucida Pi) interpretation (Diagnostic Test)
结局指标
主要结局
Proportion of men with clinically significant cancer
时间窗: When biopsy results available, at an expected average of 30 days post-biopsy
Proportion of men with clinically significant cancer detected (any pattern 4 disease on any core (i.e. Gleason Grade ≥ 3+4/Gleason grade group ≥2).
次要结局
- Proportion of men with clinically insignificant cancer(When biopsy results available, at an expected average of 30 days post-biopsy)
- Proportion of men with non-suspicious MRIs(When MRI results available, at an expected average of 30 days post-MRI)
- Proportion of MRIs with indeterminate scores.(When MRI results available, at an expected average of 30 days post-MRI)
- Agreement between AI and Radiologist in score of suspicion(When MRI results available, at an expected average of 30 days post-MRI)
- Diagnostic test performance characteristics (AI versus Radiologist)(When biopsy results available, at an expected average of 30 days post-biopsy)
- Diagnostic test performance characteristics (AI plus Radiologist)(When biopsy results available, at an expected average of 30 days post-biopsy)
- Diagnostic test performance characteristics (AI-assisted Radiologist)(When biopsy results available, at an expected average of 30 days post-biopsy)
- Significant cancer detected by peri-lesional biopsies(When biopsy results available, at an expected average of 30 days post-biopsy)
- Significant cancer detected by systematic biopsies(When biopsy results available, at an expected average of 30 days post-biopsy)
- Frequency of AI failures(When MRI results available, at an expected average of 30 days post-MRI)
- Treatment eligibility decisions(When biopsy results available, at an expected average of 30 days post-biopsy)
- Cost-efffectiveness(At an expected average of 30 days post-intervention)