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.
Men at least 18 years of age referred with clinical suspicion of prostate cancer
Serum PSA ≤ 20 ng/mL
Fit to undergo all procedures listed in the protocol
Able to provide written informed consent
Prior prostate biopsy
Prior prostate MRI on a previous encounter*
Prior treatment for prostate cancer
Contraindication to MRI (e.g. claustrophobia, pacemaker)
Single group
AI (Lucida Pi) interpretation
Diagnostic testAI algorithm that will interpretate the prostate MRI
Radiologist interpretation
Diagnostic testRadiologist will interpret the prostate MRI (as per standard of care)
Proportion of men with clinically significant cancer
Proportion of men with clinically significant cancer detected (any pattern 4 disease on any core (i.e. Gleason Grade ≥ 3+4/Gleason grade group ≥2).
Proportion of men with clinically insignificant cancer
Proportion of men with clinically insignificant cancer detected (Gleason grade 3+3/Gleason grade group 1).
Proportion of men with non-suspicious MRIs
Proportion of men with non-suspicious MRIs for AI vs Radiologists
Proportion of MRIs with indeterminate scores.
Proportion of men with indeterminately scored MRI as reported by AI vs radiologists
Agreement between AI and Radiologist in score of suspicion
Compare the proportion of MRIs with concordant scores between AI and Radiologist in score of suspicion
Click on the lead sponsor to view all of their trials.
University College, London
Lead sponsor
Lucida Medical Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
