NCT06362291

Comparison of MRI AI-cTB Versus Routine cTB in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial

Comparison of MRI Artificial Intelligence-guided Cognitive Fusion-targeted Biopsy Versus Routine Cognitive Fusion-targeted Prostate Biopsy in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: Male
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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. 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? 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.

Detailed description

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. 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. 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? This prospective, single-institution RCT compared the csPCa detection rates of the AI-cTB and routine cTB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from August 2023 to July 2024. 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	MRI-AI guided cognitive prostate targeted biopsy	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.
PROCEDURE	Routine cognitive prostate targeted biopsy	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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-03-31
• Completion: 2024-10-31
• First posted: 2024-04-12
• Last updated: 2024-11-20

Locations

1 site across 1 country: China