To hear about similar clinical trials, please enter your email below

Trial Title: Artificial Intelligence-Based Computer-Aided Diagnosis of Prostate Cancer

NCT ID: NCT05513638

Condition: the Application of Artificial Intelligence in the Diagnosis of Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms
Disease

Conditions: Keywords:
artificial intelligence
prostate cancer
magnetic resonance imaging

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: the clinical use of artificial intelligence in the diagnosis of prostate cancer
Description: 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.
Arm group label: The First Affiliated Hospital of Nanjing Medical University
Arm group label: The First Affiliated Hospital of Soochow University

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.

Criteria for eligibility:

Study pop:
Patients ≥ 60 years of age who are clinical suspicious of prostate cancer, presenting with an elevated prostatic specific antigen and/or abnormal digital rectal examination during the study enrollment period, will be eligible for inclusion. Patients will be excluded from screening if they are: (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.

Sampling method: Probability Sample
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.

Gender: Male

Minimum age: 60 Years

Maximum age: 90 Years

Healthy volunteers: No

Locations:

Facility:
Name: Yu-Dong Zhang

Address:
City: Nanjing
Zip: 210029
Country: China

Status: Recruiting

Contact:
Last name: Yu-Dong Zhang, MD;PHD

Phone: 15805151704
Email: njmu_zyd@163.com

Start date: August 22, 2022

Completion date: August 22, 2026

Lead sponsor:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Collaborator:
Agency: The First Affiliated Hospital of Soochow University
Agency class: Other

Source: The First Affiliated Hospital with Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05513638

Login to your account

Did you forget your password?