Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis

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.