Status:
RECRUITING
Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy
Lead Sponsor:
Shanghai East Hospital
Collaborating Sponsors:
Peking Union Medical College Hospital
1st hospital of xi'an jiaotong university
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 si...
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 whe...
Eligibility Criteria
Inclusion
- Age \> 18
- PSA increase to 4-20 ng/ml and/or abnormal DRE;
- Sign the informed consent
Exclusion
- Have acute or chronic prostatitis
- Contraindications to prostate biopsy
- Contraindications to MRI
- Other reasons that not suitable for this trial
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 14 2025
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT04271527
Start Date
February 20 2024
End Date
May 14 2025
Last Update
August 16 2024
Active Locations (1)
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1
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China, 200120