NCT04271527

Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy

Non-inferiority Randomized Controlled Trial of Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 626 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This trial is a prospective, multi-centre, randomized controlled, and non-inferiority study in which all men suspicious to have clinically significant prostate cancer. This study aims to determine whether the cognitive fusion targeted biopsy is non-inferior to software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	cognitive fusion targeted biopsy	A cognitive fusion targeted biopsy

Timeline

• Start date: 2024-02-20
• Primary completion: 2025-04-01
• Completion: 2025-05-14
• First posted: 2020-02-17
• Last updated: 2024-08-16

Locations

1 site across 1 country: China