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The goal of this multicenter clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. The main questions it aims to answer are:
Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? What's the generalizability of the MRI artificial intelligence assistant diagnosis system?
Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB.
Participants will:
Receive AI-cTB or routine cTB.
Cognitive fusion MRI-guided targeted biopsy (cTB) has been widely used in the diagnosis of prostate cancer (PCa). However, cTB relies heavily on the operator's experience and confidence in MRI readings. Our previously single-center RCT has demonstrated the effectiveness of accurately detecting clinically significant PCa (csPCa). The goal of this clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. This multicenter RCT aims to further validate the ability of MRI artificial intelligence in different institutions and investigate the generalizability of the MRI artificial intelligence assistant diagnosis system.
The main questions it aims to answer are:
Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? What's the generalizability of the MRI artificial intelligence assistant diagnosis system? This multicenter RCT compared the csPCa detection rates of the AI-cTB and routine cTB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China), Beijing Miyun District Hospital (Beijing, China), and Shanghai East Hospital (Shanghai, China) from May 2024 to April 2025.
Participants were randomly allocated to AI-cTB group and routine cTB group. Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB.
Participants will:
Receive AI-cTB or routine cTB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI-AI-guided cTB (AI-cTB) group | Experimental | The trained AI algorithms were embedded into proprietary structured reporting software. Before prostate biopsy, the MR images of patients in the AI-cTB group were uploaded to the AI software. The prostate gland and suspicious lesions were annotated and highlighted by AI software. The urologists who were blinded to the picture archiving and communication system (PACS) and MRI reports read the AI findings at their discretion and then conducted 3-5 core TB at each suspicious lesion, followed by 12 core SB. If there was no suspicious lesion detected by the AI, only SB would be performed. |
|
| Routine cTB group | Experimental | For patients in the cTB group, the MR images and reports were viewed by urologists preceding the biopsy. Then 3-5 core cTB were performed, followed by 12 core SB. In patients with negative MRI findings, only SB was performed. When urologists performed biopsies, ultrasound technicians and radiologists were present to provide necessary assistance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI-AI guided cognitive prostate targeted biopsy | Procedure | Before prostate biopsy, the MR images of patients in the AI-cTB group were uploaded to the AI software. Then the images with suspicious lesions highlighted by AI software were viewed by urologists. Biopsies were performed under the guidance of TRUS through the transrectal or transperineal route. |
| Measure | Description | Time Frame |
|---|---|---|
| The clinically significant prostate cancer (csPCa) detection rate for targeted biopsy (TB) and TB combined with systematic biopsy (SB) | csPCa was defined as PCa with a grade group > 2 or GS ≥ 7. The reference standard was the pathological results of the combination of TB (AI-cTB or cTB) and SB. | One month after the biopsy procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| The PCa detection rate | The PCa detection rate for targeted biopsy (TB) and TB combined with systematic biopsy (SB). | One month after the biopsy procedure. |
| The Gleason score (GS) of the biopsy sample |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi LIU | Contact | +86 13611035261 | liuyipkuhsc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi LIU | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Routine cognitive prostate targeted biopsy | Procedure | Before prostate biopsy, the MR images and reports were viewed by urologists preceding the biopsy. Biopsies were performed under the guidance of TRUS through the transrectal or transperineal route. |
|
The Gleason score was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group.
| One month after the biopsy procedure. |
| The GS of radical prostatectomy (RP) specimens | The overall grade was assigned based on the part with the highest Gleason score according to the recommendations of the ISUP | One month after the biopsy procedure. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |