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

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

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.

Aim: To assess whether artificial intelligence is non-inferior to radiologists in the diagnosis of clinically significant prostate cancer on MRI.

Objectives

Primary

1. To compare the proportion of men who have clinically significant prostate cancer detected on MRI using AI ± targeted biopsy with radiologists ± targeted biopsy.

Secondary

1. To compare the proportion of men who have clinically insignificant prostate cancer detected on MRI using AI ± targeted biopsy with radiologists ± targeted biopsy.
2. To compare the proportion of men with non-suspicious MRIs for AI vs radiologists.
3. To compare the proportion of men with indeterminately scored MRI as reported by AI vs radiologists.
4. To compare the diagnostic test performance of AI vs radiologist.
5. To compare the additive value of AI when used together with a radiologist interpretation (summative of all identified lesions) compared to a radiologist alone.
6. To compare the additive value of AI when used together with a radiologist interpretation (where the radiologist can interact with the AI system by accepting or rejecting AI-identified lesions) compared to a radiologist alone.
7. To determine the frequency of AI failures.
8. To compare treatment eligibility decisions between AI and Radiologist.
9. To compare the cost-effectiveness of unblinded AI interpreted by the radiologist compared to radiologist alone for prostate cancer detection, and AI alone vs. radiologist alone, and a 3-arm analysis considering all three.

Design:

Prospective, international, within-patient, multi-centre, level-1 evidence trial in participants referred to hospital with a clinical suspicion of prostate cancer.

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.