Non-inferiority Randomized Controlled Trial of Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a randomized controlled and non-inferiority trial in comparison of the cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:
• Age \> 18
• PSA increase to 4-20 ng/ml and/or abnormal DRE;
• Sign the informed consent
Locations
Other Locations
China
Shanghai East Hospital, Tongji University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Biming He, MD
190589109@qq.com
+8615502139410
Backup
Haifeng Wang, MD
446720864@qq.com
+8613681750891
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2025-05-14
Participants
Target number of participants: 626
Treatments
Experimental: cognitive targeted biopsy
a cognitive fusion targeted biopsy combined with a systematic biopsy
Active_comparator: software targeted biopsy
software-based fusion targeted biopsy combined with a systematic biopsy
Related Therapeutic Areas
Sponsors
Collaborators: The First Affiliated Hospital of Henan university of CM, Qilu Hospital of Shandong University, Peking Union Medical College Hospital, The First Affiliated Hospital of Zhengzhou University, 1st hospital of xi'an jiaotong university, Peking University First Hospital, The University of Hong Kong-Shenzhen Hospital, 2nd hospital of xi'an jiaotong university, Zibo Central Hospital, Shandong Provincial Hospital
Leads: Shanghai East Hospital