This study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and AI-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy.
This study is a prospective randomized controlled clinical trial designed to investigate the efficacy of AI-assisted biopsy methods compared to conventional biopsy methods in detecting clinically significant prostate cancer. The target population includes patients undergoing their initial prostate biopsy who meet established indications for prostate biopsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
602
utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process
undergo standard prostate biopsy procedures without additional technological assistance
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, China
The detection rate of clinically significant prostate cancer by targeted biopsy alone
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
Time frame: 2-3 weeks post-biopsy
The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined targeted biopsy samples
Time frame: 2-3 weeks post-biopsy
The detection rate of any prostate cancer by targeted biopsy alone
The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples
Time frame: 2-3 weeks post-biopsy
The detection rate of any prostate cancer by targeted biopsy combined with template biopsy
The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined targeted biopsy samples
Time frame: 2-3 weeks post-biopsy
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