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Recruiting NCT04271527

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

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Plain-language summary for patients

Trial Parameters

Condition Prostate Cancer
Sponsor Shanghai East Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 626
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2024-02-20
Completion 2025-04-01
Interventions
cognitive fusion targeted biopsy

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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 significant cancer in men suspected to have a PCa.

Eligibility Criteria

Inclusion Criteria: 1. Age \> 18 2. PSA increase to 4-20 ng/ml and/or abnormal DRE; 3. Sign the informed consent Exclusion Criteria: 1. Have acute or chronic prostatitis 2. Contraindications to prostate biopsy 3. Contraindications to MRI 4. Other reasons that not suitable for this trial

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