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

RECRUITINGN/ASponsored by Shanghai East Hospital
Actively Recruiting
PhaseN/A
SponsorShanghai East Hospital
Started2024-02-20
Est. completion2025-04-01
Eligibility
Age18 Years+
SexMALE
Healthy vol.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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

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