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.

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 60
Maximum Age: 90
Healthy Volunteers: f
View:

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

Locations
Other Locations
China
Yu-Dong Zhang
RECRUITING
Nanjing
Time Frame
Start Date: 2022-08-22
Estimated Completion Date: 2026-08-22
Participants
Target number of participants: 2000
Treatments
The First Affiliated Hospital of Nanjing Medical University
The First Affiliated Hospital of Soochow University
Sponsors
Collaborators: The First Affiliated Hospital of Soochow University
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov