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

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

Recruiting
18 years and older
Male
Phase N/A
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Overview

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.

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.

Eligibility

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

Study details
    Prostate Cancer

NCT04271527

Shanghai East Hospital

14 October 2025

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