Study on Prostate Targeted Biopsy Precision Navigation Method Based on Multi-Modal Image Fusion Deep Learning Using Multi-Parameter Ultrasound and MRI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 602
- Locations
- 1
- Primary Endpoint
- The detection rate of clinically significant prostate cancer by targeted biopsy alone
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •PSA > 4 ng/ml and/or abnormal DRE
- •Sign the informed consent
Exclusion Criteria
- •Have acute or chronic prostatitis
- •Contraindications to prostate biopsy
- •Contraindications to MRI
- •Other reasons that not suitable for this trial
Outcomes
Primary Outcomes
The detection rate of clinically significant prostate cancer by targeted biopsy alone
Time Frame: 2-3 weeks post-biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
Secondary Outcomes
- The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy(2-3 weeks post-biopsy)
- The detection rate of any prostate cancer by targeted biopsy alone(2-3 weeks post-biopsy)
- The detection rate of any prostate cancer by targeted biopsy combined with template biopsy(2-3 weeks post-biopsy)