Actively Recruiting

Phase Not Applicable
Age: 45Years - 85Years
MALE
NCT06392737

Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis

Led by Peking University First Hospital · Updated on 2025-07-02

360

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this multicenter clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. The main questions it aims to answer are: Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? What's the generalizability of the MRI artificial intelligence assistant diagnosis system? Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB. Participants will: Receive AI-cTB or routine cTB.

CONDITIONS

Official Title

Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis

Who Can Participate

Age: 45Years - 85Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 45 and 85 years
  • Complete multiparametric MRI data with quality control and suspicious lesions with PI-RADS V2.1 score of 3 or higher
  • Indication for prostate biopsy including suspicious prostate nodes from digital rectal exam, suspicious lesions from ultrasound or MRI, total PSA >10 ng/mL, total PSA 4-10 ng/mL with free-to-total PSA ratio <0.16 or PSA density >0.15
  • Indication for repeated prostate biopsy with specific pathological or PSA criteria and a minimum interval of three months between biopsies
  • Complete targeted prostate biopsy pathological results with biopsy and MRI performed within one month
  • Complete clinical information
Not Eligible

You will not qualify if you...

  • Unqualified or incomplete multiparametric MRI data
  • Prior radiotherapy, chemotherapy, androgen deprivation therapy, or surgery before MRI or biopsy
  • No suspicious prostate lesions found on MRI
  • Not meeting indication for prostate biopsy or have not received combined systematic and targeted biopsy
  • Unable or unwilling to complete combined biopsy or participate in the study
  • Incomplete clinical information

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

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Research Team

Y

Yi LIU

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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