Actively Recruiting
Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis
Led by Peking University First Hospital · Updated on 2025-07-02
360
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this multicenter clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. The main questions it aims to answer are: Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? What's the generalizability of the MRI artificial intelligence assistant diagnosis system? Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB. Participants will: Receive AI-cTB or routine cTB.
CONDITIONS
Official Title
Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45 and 85 years
- Complete multiparametric MRI data with quality control and suspicious lesions with PI-RADS V2.1 score of 3 or higher
- Indication for prostate biopsy including suspicious prostate nodes from digital rectal exam, suspicious lesions from ultrasound or MRI, total PSA >10 ng/mL, total PSA 4-10 ng/mL with free-to-total PSA ratio <0.16 or PSA density >0.15
- Indication for repeated prostate biopsy with specific pathological or PSA criteria and a minimum interval of three months between biopsies
- Complete targeted prostate biopsy pathological results with biopsy and MRI performed within one month
- Complete clinical information
You will not qualify if you...
- Unqualified or incomplete multiparametric MRI data
- Prior radiotherapy, chemotherapy, androgen deprivation therapy, or surgery before MRI or biopsy
- No suspicious prostate lesions found on MRI
- Not meeting indication for prostate biopsy or have not received combined systematic and targeted biopsy
- Unable or unwilling to complete combined biopsy or participate in the study
- Incomplete clinical information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
Y
Yi LIU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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