Clinical trial · Observational
Artificial Intelligence-Based Computer-Aided Diagnosis of Prostate Cancer
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| the Application of Artificial Intelligence in the Diagnosis of Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the clinical use of artificial intelligence in the diagnosis of prostate cancer | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- The First Affiliated Hospital of Nanjing Medical University
- interventionNames
- Diagnostic Test: the clinical use of artificial intelligence in the diagnosis of prostate cancer
- label
- The First Affiliated Hospital of Soochow University
- interventionNames
- Diagnostic Test: the clinical use of artificial intelligence in the diagnosis of prostate cancer
Primary outcomes (1)
- measure
- biopsy or surgery confirmed newly-diagnosed prostate cancer and clinically significant prostate cancer
- timeFrame
- Aug,22nd,2022-Aug,22nd,2024
- description
- Biopsy or surgery confirmed newly-diagnosed prostate cancer and clinically significant prostate cancer will serve as our primary outcome. Details of follow up and disease progression for a period of two years following mp-MRI will also be collected. For patients with no suspicious lesions on mp-MRI or biopsy-negative, follow-up prostatic specific antigen for a period of two years will also be collected.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 60 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available