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

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.

Conditions

• Prostate Cancer

Interventions

PROCEDURE

cognitive fusion targeted biopsy

A cognitive fusion targeted biopsy

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• 1st hospital of xi'an jiaotong university

  collaborator UNKNOWN

• Qilu Hospital of Shandong University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Zibo Central Hospital

  collaborator OTHER_GOV

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital of Henan university of CM

  collaborator UNKNOWN

• 2nd hospital of xi'an jiaotong university

  collaborator UNKNOWN

• Peking University First Hospital

  collaborator OTHER

• The University of Hong Kong-Shenzhen Hospital

  collaborator OTHER

• Shanghai East Hospital

  lead OTHER

Principal Investigators

• Haifeng Wang, MD · Shanghai East Hospital,Tongji University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-20

Primary Completion

2025-04-01

Completion

2025-05-14

Countries

• China

Study Locations