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

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.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

1. Men at least 18 years of age referred with clinical suspicion of prostate cancer
2. Serum PSA ≤ 20 ng/mL
3. Fit to undergo all procedures listed in the protocol
4. Able to provide written informed consent

Exclusion Criteria:

1. Prior prostate biopsy
2. Prior prostate MRI on a previous encounter\*
3. Prior treatment for prostate cancer
4. Contraindication to MRI (e.g. claustrophobia, pacemaker)
5. Metalwork that would give rise to artefact on MRI (e.g. hip prosthesis, pelvic/spinal metalwork)
6. Contraindication to prostate biopsy
7. Unfit to undergo any procedures listed in protocol

   * An MRI on a previous encounter means a previous prostate MRI which has been seen by a doctor and has been used to inform patient management at the time of the original MRI.