Prostate Cancer
Conditions
Keywords
Prostate Cancer, targeted biopsy
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.
Interventions
PROCEDUREAI-assisted
utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process
PROCEDURENon-AI-assisted
undergo standard prostate biopsy procedures without additional technological assistance
Sponsors
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary Contactshuaidong wang
Backup Contacthaifeng wang
Outcome results
None listed