About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Prior prostate biopsy
Prior prostate MRI on a previous encounter*
Prior treatment for prostate cancer
Contraindication to MRI (e.g. claustrophobia, pacemaker)
Trial design
Treatments tested in this trial
- AI (Lucida Pi) interpretation
- Radiologist interpretation
Treatment groups
Locations
Sponsors and collaborators
University College, London
Lead sponsor
Lucida Medical Ltd
Collaborator