Peking University First Hospital
l U Y
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.
Prostate Cancer
MRI-AI guided cognitive prostate targeted biopsy
Routine cognitive prostate targeted biopsy
Not Applicable
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.
Study Type : | Interventional |
Estimated Enrollment : | 360 participants |
Masking : | Single |
Primary Purpose : | Diagnostic |
Official Title : | Comparison of MRI Artificial Intelligence-guided Cognitive Fusion-targeted Biopsy Versus Routine Cognitive Fusion-targeted Prostate Biopsy in Prostate Cancer Diagnosis: a Multicenter Randomized Controlled Clinical Trial |
Actual Study Start Date : | May 1, 2024 |
Estimated Primary Completion Date : | April 30, 2025 |
Estimated Study Completion Date : | April 30, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: MRI-AI-guided cTB (AI-cTB) group 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. |
Procedure: MRI-AI guided cognitive prostate targeted biopsy |
Experimental: Routine cTB group 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. |
Procedure: Routine cognitive prostate targeted biopsy |
Ages Eligible for Study: | 45 Years to 85 Years |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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Recruiting
Peking University First Hospital
Beijing, Beijing, China, 100034