Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional biopsy group | Active Comparator | undergo standard prostate biopsy procedures without additional technological assistance |
|
| AI-assisted biopsy group | Experimental | utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-assisted | Procedure | utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2-3 weeks post-biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2-3 weeks post-biopsy |
| The detection rate of any prostate cancer by targeted biopsy alone |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shuaidong wang | Contact | 15102100859 | wangshuaidong_wsd@163.com | |
| haifeng wang | Contact | 13681750891 | kuohaiandrew2000@vip.sina.com.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital, Tongji University School of Medicine | Shanghai | 200120 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-AI-assisted | Procedure | undergo standard prostate biopsy procedures without additional technological assistance |
|
The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples |
| 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 | 2-3 weeks post-biopsy |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |