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NOT YET RECRUITING
NCT07647445
NA

Prostate MRI Analysis by Radiologists and Artificial Intelligence - Disease Identification and Guided Management

Sponsor: University College, London

View on ClinicalTrials.gov

Summary

Prostate cancer is the most common male cancer in 112 countries and makes up 7% of global cancer cases, and is the second leading cause of cancer-related deaths in men. Normally, men with suspected prostate cancer undergo a prostate MRI, and then a Radiologist would review this scan to identify any suspicious areas for cancer within the prostate. Prostate MRI interpretation, however, is an expert skill with a steep learning curve, and internationally, there is a growing shortage of Radiologists. The PARADIGM trial aims to assess if AI can perform just as well as Radiologists in interpreting prostate MRI scans to identify prostate cancer. Enrolled participants will undergo a prostate MRI, which is the normal method used for investigating suspected prostate cancer. AI and a Radiologist will both interpret the MRI, without knowledge of each other's interpretation. Once both reports have been made, the Radiologist will be asked to produce a third, combined report. If there is a suspicious area in the prostate identified either by AI or the Radiologist, targeted biopsies will be performed. If there are no suspicious areas on the MRI and if you are at low risk of harbouring cancer, which occurs in about 30% of men, then no biopsy will be taken at all.

Official title: A Study Assessing Whether Artificial Intelligence is Non-inferior to Radiologists in the Diagnosis of Clinically Significant Prostate Cancer.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-10

Completion Date

2029-01

Last Updated

2026-06-30

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

AI (Lucida Pi) interpretation

AI algorithm that will interpretate the prostate MRI

DIAGNOSTIC_TEST

Radiologist interpretation

Radiologist will interpret the prostate MRI (as per standard of care)