Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
Healthy Volunteers
NCT04271527

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

Led by Shanghai East Hospital · Updated on 2024-08-16

626

Participants Needed

1

Research Sites

64 weeks

Total Duration

On this page

Sponsors

S

Shanghai East Hospital

Lead Sponsor

P

Peking Union Medical College Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • PSA level increased to 4-20 ng/ml and/or abnormal digital rectal exam
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Acute or chronic prostatitis
  • Contraindications to prostate biopsy
  • Contraindications to MRI
  • Other reasons making the participant unsuitable for this trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China, 200120

Actively Recruiting

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Research Team

B

Biming He, MD

CONTACT

H

Haifeng Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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