Artificial Intelligence-Based Computer-Aided Diagnosis of Prostate Cancer

Официальное название

Safety and Accuracy of Artificial Intelligence-aided Precision MRI Assessment for the Optimization of Prostate Biopsy in Men With Suspicion of Prostate Cancer: a Multicenter Randomized Controlled Trial.

Обзор

One-fifth of all men will develop clinically significant prostate cancers (CsPC) in their lifetime. An estimated 268,490 new prostate cancer (PCa) cases and 34,500 deaths are expected in the United States during the year 2022, making PCa the second most common cause of cancer-related deaths in men. MRI with the Prostate Imaging Reporting and Data System (PI-RADS) is a current widely used communicative tool for both CsPC detection and guiding targeted prostate biopsy. The high level of expertise required for accurate interpretation and persistent inter-reader variability has limited consistency and it has hindered the widespread adoption of PI-RADS. Artificial intelligence (AI) shows a broad prospect for medical interpretation and triage in various challenging tasks , including the PCa detection and staging with MRI. While rapid technical advances are furthering the application of AI medical imaging, their implementation in clinical practice remains a major hurdle. Besides, the prospect of data-derived AI tool is to assist human experts rather than replace them, and whether AI can match or exceed the human experts is still a matter of debate. Therefore, despite strong potential, there is urgent need for research to better quantify the accuracy, generalizability and clinical applicability before the clinical use of an AI in a real-world clinical setting.

Вмешательства

• Диагностический тест the clinical use of artificial intelligence in the diagnosis of prostate cancer
  Each study site will enroll consecutive eligible patients and randomize them to either (a) a group with human-based interpretation or (b) a group with human-artificial intelligence interactive interpretation, both of which are utilized as standards of care.

Первичные конечные точки

• biopsy or surgery confirmed newly-diagnosed prostate cancer and clinically significant prostate cancer [Срок оценки: Aug,22nd,2022-Aug,22nd,2024]

Вторичные конечные точки (3)

• surgery confirmed T and N staging of prostate cancer [Срок оценки: Aug,22nd,2022-Aug,22nd,2024]
• positive rate of prostate biopsy [Срок оценки: Aug,22nd,2022-Aug,22nd,2024]
• the total reviewing time [Срок оценки: Aug,22nd,2022-Aug,22nd,2024]

Критерии участия

Критерии включения

• Clinical suspicious of prostate cancer, presenting with an elevated prostatic specific antigen and/or abnormal digital rectal examination

Критерии исключения

• (1) <60 years of age; (2) a previous surgery, radiotherapy or drug therapy for prostate cancer (interventions for benign prostatic hyperplasia or bladder outflow obstruction were deemed acceptable); (3) incomplete mp-MRI examination or artifacts of the images.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• Yu-Dong Zhang — Нанкин

Идентификаторы

NCT: NCT05513638 · 2019-SR-396

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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