Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: AI-assisted; Procedure: Non-AI-assisted

• Registration Number: NCT06441292
• Lead Sponsor: Shanghai East Hospital

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 Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04
• Study Start: 2024-07-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 602

Inclusion Criteria

1. Age > 18
2. PSA > 4 ng/ml and/or abnormal DRE
3. Sign the informed consent

Exclusion Criteria

1. Have acute or chronic prostatitis
2. Contraindications to prostate biopsy
3. Contraindications to MRI
4. Other reasons that not suitable for this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI-assisted biopsy group	AI-assisted	utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process
conventional biopsy group	Non-AI-assisted	undergo standard prostate biopsy procedures without additional technological assistance

Primary Outcome Measures

Name	Time	Method
The detection rate of clinically significant prostate cancer by targeted biopsy alone	2-3 weeks post-biopsy	The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples

Secondary Outcome Measures

Name	Time	Method
The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy	2-3 weeks post-biopsy	The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined targeted biopsy samples
The detection rate of any prostate cancer by targeted biopsy alone	2-3 weeks post-biopsy	The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples
The detection rate of any prostate cancer by targeted biopsy combined with template biopsy	2-3 weeks post-biopsy	The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined targeted biopsy samples

Trial Locations

Locations (1)

Shanghai East Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, China