Status:
COMPLETED
Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis
Lead Sponsor:
Peking University First Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
45-85 years
Phase:
NA
Brief Summary
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). The main ...
Detailed Description
In recent years, there have been remarkable advancements in the field of artificial intelligence (AI) techniques, particularly in the medical domain. These AI techniques have demonstrated the ability ...
Eligibility Criteria
Inclusion
- The age of the patient is between 45 and 85.
- Patients with complete multiparametric magnetic resonance imaging (mpMRI) data, qualified image quality control.
- Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \>10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) \<0.16 or PSA density (PSAD) \>0.15.
- Patients had no history of prior prostate surgery or biopsy.
- The PSA of patients should be ≤20 ng/mL.
- The prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate mpMRI examination should not exceed one month.
- Patients with complete clinical information.
Exclusion
- The clinicopathological information and mpMRI data was unqualified or incomplete.
- Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
- Patients received prior prostate biopsy.
- Patients had contraindications to MRI or prostate biopsy.
- Patients were not in accordance with the indication of prostate biopsy.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT06575361
Start Date
January 1 2024
End Date
August 31 2025
Last Update
November 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034