Actively Recruiting

Age: 18Years +
MALE
NCT05513820

Automatic Detection in MRI of Prostate Cancer: DAICAP

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-05-20

1250

Participants Needed

1

Research Sites

127 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

University Hospital, Strasbourg, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

Prostate cancer is the most common cancer in France and the 3rd most common cancer death in humans. The introduction of pre-biopsy MRI has considerably improved the quality of prostate cancer (PCa) diagnosis by increasing the detection of clinically significant PCa , and by reducing the number of unnecessary biopsies.However the diagnostic performance of Prostate MRI is highly dependent on reader experience that limits the population based delivery of high quality multiparametricMRI (mpMRI) driven PCa diagnosis. The main objective of this study is the development and the test of diagnostic accuracy of an AI algorithm for the detection of cancerous prostatic lesions from mpMRI images. The secondary objective is the development and the test of diagnostic accuracy of an AI algorithm to predict tumor aggressiveness from mpMRI images.

CONDITIONS

Official Title

Automatic Detection in MRI of Prostate Cancer: DAICAP

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 years or older
  • Clinical suspicion of prostate cancer based on increased PSA and/or abnormal digital rectal exam
  • Diagnostic workup including multiparametric MRI and prostate biopsies following national guidelines
  • For normal mpMRI (PI-RADS < 3), 12 systematic biopsy samples required
  • For pathological mpMRI (PI-RADS ≥ 3), 12 systematic samples plus 2 to 4 targeted biopsy samples by cognitive or image fusion
Not Eligible

You will not qualify if you...

  • Patients with histologically confirmed prostate cancer prior to diagnostic workup
  • Patients who have received treatment for prostate cancer before the study
  • Patients unable to have prostate biopsies
  • Patients with contraindications to performing multiparametric MRI

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

La Pitié Salpétrière Hospital

Paris, France, 75013

Actively Recruiting

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Research Team

R

Raphaële Renard-Penna, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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