评估人工智能驱动的基于 MRI 的优化前列腺癌诊断途径
ProstateAI - 一项前瞻性配对验证队列研究，用于评估人工智能驱动的基于 MRI 的优化前列腺癌诊断途径
It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.
研究概览
详细说明
ProstateAI is a prospective paired-cohort study for diagnostic test evaluation. ProstateAI will determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Peter Ka-Fung CHIU, FRCS, PhD
- 电话号码：35052625
- 邮箱：peterchiu@surgery.cuhk.edu.hk
学习地点
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Hong Kong、香港
- 招聘中
- Prince of Wales Hospital, Chinese University of Hong Kong
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接触：
- Peter Ka Fung CHIU, MBChB
- 电话号码：852-3505-2625
- 邮箱：peterchiu@surgery.cuhk.edu.hk
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients recommended for prostate biopsy for diagnosis or re-assessment.
- Men at least 18 years or over
- Patients with prostate MRI image eligible for radiologist review and AI review.
- Patient Informed Consent is signed.
Exclusion Criteria:
- Patient contraindicated to prostate biopsy
- Patient failed to complete the biopsy procedure
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：AI review (index)
self-paired design, AI review (index) |
The MRI image will be reviewed by radiologist and AI model(s) respectively. The urologist will combine the results of the two approaches to optimize the biopsy strategy which is expected to result in more accurate diagnosis. |
|
有源比较器：Radiologist review (Standard)
self-paired design, radiologist review (standard) |
The MRI image will be reviewed by radiologist. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Prostate Cancer detection rate of ISUP grade group ≥2
大体时间：Through study completion, an average of 1 year
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Assessed by AI review, Radiologist review, and Biopsy (Targeted). |
Through study completion, an average of 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnosis of any grade of prostate cancer
大体时间：Through study completion, an average of 1 year
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Assessed by prostate biopsy |
Through study completion, an average of 1 year
|
合作者和调查者
调查人员
- 首席研究员：Peter CHIU, FRCS, PhD、Chinese University of Hong Kong
出版物和有用的链接
一般刊物
- Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
- Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.
- Siddiqui MM, Rais-Bahrami S, Truong H, Stamatakis L, Vourganti S, Nix J, Hoang AN, Walton-Diaz A, Shuch B, Weintraub M, Kruecker J, Amalou H, Turkbey B, Merino MJ, Choyke PL, Wood BJ, Pinto PA. Magnetic resonance imaging/ultrasound-fusion biopsy significantly upgrades prostate cancer versus systematic 12-core transrectal ultrasound biopsy. Eur Urol. 2013 Nov;64(5):713-719. doi: 10.1016/j.eururo.2013.05.059. Epub 2013 Jun 12.
- Ilic D, Djulbegovic M, Jung JH, Hwang EC, Zhou Q, Cleves A, Agoritsas T, Dahm P. Prostate cancer screening with prostate-specific antigen (PSA) test: a systematic review and meta-analysis. BMJ. 2018 Sep 5;362:k3519. doi: 10.1136/bmj.k3519.
- Wei JT, Barocas D, Carlsson S, Coakley F, Eggener S, Etzioni R, Fine SW, Han M, Kim SK, Kirkby E, Konety BR, Miner M, Moses K, Nissenberg MG, Pinto PA, Salami SS, Souter L, Thompson IM, Lin DW. Early Detection of Prostate Cancer: AUA/SUO Guideline Part II: Considerations for a Prostate Biopsy. J Urol. 2023 Jul;210(1):54-63. doi: 10.1097/JU.0000000000003492. Epub 2023 Apr 25.
- Bass EJ, Pantovic A, Connor MJ, Loeb S, Rastinehad AR, Winkler M, Gabe R, Ahmed HU. Diagnostic accuracy of magnetic resonance imaging targeted biopsy techniques compared to transrectal ultrasound guided biopsy of the prostate: a systematic review and meta-analysis. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):174-179. doi: 10.1038/s41391-021-00449-7. Epub 2021 Sep 21.
- Wegelin O, van Melick HHE, Hooft L, Bosch JLHR, Reitsma HB, Barentsz JO, Somford DM. Comparing Three Different Techniques for Magnetic Resonance Imaging-targeted Prostate Biopsies: A Systematic Review of In-bore versus Magnetic Resonance Imaging-transrectal Ultrasound fusion versus Cognitive Registration. Is There a Preferred Technique? Eur Urol. 2017 Apr;71(4):517-531. doi: 10.1016/j.eururo.2016.07.041. Epub 2016 Aug 25.
- Wei C, Szewczyk-Bieda M, Bates AS, Donnan PT, Rauchhaus P, Gandy S, Ragupathy SKA, Singh P, Coll K, Serhan J, Wilson J, Nabi G. Multicenter Randomized Trial Assessing MRI and Image-guided Biopsy for Suspected Prostate Cancer: The MULTIPROS Study. Radiology. 2023 Jul;308(1):e221428. doi: 10.1148/radiol.221428.
- Annamalai A, Fustok JN, Beltran-Perez J, Rashad AT, Krane LS, Triche BL. Interobserver Agreement and Accuracy in Interpreting mpMRI of the Prostate: a Systematic Review. Curr Urol Rep. 2022 Jan;23(1):1-10. doi: 10.1007/s11934-022-01084-y. Epub 2022 Feb 28.
- Schergna E, Armani M. [Muscular diseases: epidemiology of progressive muscular dystrophies]. Minerva Med. 1981 Apr 28;72(17):1045-9. Italian.
- Halstuch D, Baniel J, Lifshitz D, Sela S, Ber Y, Margel D. Characterizing the learning curve of MRI-US fusion prostate biopsies. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):546-551. doi: 10.1038/s41391-019-0137-2. Epub 2019 Mar 6.
- Kasabwala K, Patel N, Cricco-Lizza E, Shimpi AA, Weng S, Buchmann RM, Motanagh S, Wu Y, Banerjee S, Khani F, Margolis DJ, Robinson BD, Hu JC. The Learning Curve for Magnetic Resonance Imaging/Ultrasound Fusion-guided Prostate Biopsy. Eur Urol Oncol. 2019 Mar;2(2):135-140. doi: 10.1016/j.euo.2018.07.005. Epub 2018 Aug 17.
- Bhattacharya I, Khandwala YS, Vesal S, Shao W, Yang Q, Soerensen SJC, Fan RE, Ghanouni P, Kunder CA, Brooks JD, Hu Y, Rusu M, Sonn GA. A review of artificial intelligence in prostate cancer detection on imaging. Ther Adv Urol. 2022 Oct 10;14:17562872221128791. doi: 10.1177/17562872221128791. eCollection 2022 Jan-Dec.
- Lomas DJ, Ahmed HU. All change in the prostate cancer diagnostic pathway. Nat Rev Clin Oncol. 2020 Jun;17(6):372-381. doi: 10.1038/s41571-020-0332-z. Epub 2020 Feb 28.
- Lenfant L, Beitone C, Troccaz J, Roupret M, Seisen T, Voros S, Mozer PC. Learning curve for fusion magnetic resonance imaging targeted prostate biopsy and three-dimensional transrectal ultrasonography segmentation. BJU Int. 2024 Jun;133(6):709-716. doi: 10.1111/bju.16287. Epub 2024 Jan 31.
- Halabi S, Lin CY, Kelly WK, Fizazi KS, Moul JW, Kaplan EB, Morris MJ, Small EJ. Updated prognostic model for predicting overall survival in first-line chemotherapy for patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2014 Mar 1;32(7):671-7. doi: 10.1200/JCO.2013.52.3696. Epub 2014 Jan 21.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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