Artificial Intelligence-Based Computer-Aided Diagnosis of Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: the clinical use of artificial intelligence in the diagnosis of prostate cancer.
- Who it may be relevant to
- Registry conditions: the Application of Artificial Intelligence in the Diagnosis of Prostate Cancer. Basic parameters: 60 years — 90 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Interventions
- Diagnostic test 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.
Primary outcome measures
- biopsy or surgery confirmed newly-diagnosed prostate cancer and clinically significant prostate cancer [Time frame: Aug,22nd,2022-Aug,22nd,2024]
Secondary outcome measures (3)
- surgery confirmed T and N staging of prostate cancer [Time frame: Aug,22nd,2022-Aug,22nd,2024]
- positive rate of prostate biopsy [Time frame: Aug,22nd,2022-Aug,22nd,2024]
- the total reviewing time [Time frame: Aug,22nd,2022-Aug,22nd,2024]
Eligibility criteria
Inclusion criteria
- Clinical suspicious of prostate cancer, presenting with an elevated prostatic specific antigen and/or abnormal digital rectal examination
Exclusion criteria
- (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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Yu-Dong Zhang — Nanjing
Identifiers
NCT: NCT05513638 · 2019-SR-396