Prostate MRI Analysis by Radiologists and Artificial Intelligence - Disease Identification and Guided Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI (Lucida Pi) interpretation, Radiologist interpretation.
- Who it may be relevant to
- Registry conditions: Prostate CA. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study Assessing Whether Artificial Intelligence is Non-inferior to Radiologists in the Diagnosis of Clinically Significant Prostate Cancer.
Overview
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.
Detailed description
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.
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)
Primary outcome measures
- Proportion of men with clinically significant cancer [Time frame: When biopsy results available, at an expected average of 30 days post-biopsy]
Secondary outcome measures (12)
- Proportion of men with clinically insignificant cancer [Time frame: When biopsy results available, at an expected average of 30 days post-biopsy]
- Proportion of men with non-suspicious MRIs [Time frame: When MRI results available, at an expected average of 30 days post-MRI]
- Proportion of MRIs with indeterminate scores. [Time frame: When MRI results available, at an expected average of 30 days post-MRI]
- Agreement between AI and Radiologist in score of suspicion [Time frame: When MRI results available, at an expected average of 30 days post-MRI]
- Diagnostic test performance characteristics (AI versus Radiologist) [Time frame: When biopsy results available, at an expected average of 30 days post-biopsy]
- Diagnostic test performance characteristics (AI plus Radiologist) [Time frame: When biopsy results available, at an expected average of 30 days post-biopsy]
- Diagnostic test performance characteristics (AI-assisted Radiologist) [Time frame: When biopsy results available, at an expected average of 30 days post-biopsy]
- Significant cancer detected by peri-lesional biopsies [Time frame: When biopsy results available, at an expected average of 30 days post-biopsy]
- Significant cancer detected by systematic biopsies [Time frame: When biopsy results available, at an expected average of 30 days post-biopsy]
- Frequency of AI failures [Time frame: When MRI results available, at an expected average of 30 days post-MRI]
- Treatment eligibility decisions [Time frame: When biopsy results available, at an expected average of 30 days post-biopsy]
- Cost-efffectiveness [Time frame: At an expected average of 30 days post-intervention]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Prior prostate biopsy
- Prior prostate MRI on a previous encounter\*
- Prior treatment for prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker)
- Metalwork that would give rise to artefact on MRI (e.g. hip prosthesis, pelvic/spinal metalwork)
- Contraindication to prostate biopsy
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07647445 · 338739