Prostate CAPARADIGMNCT07647445
Prostate MRI Analysis by Radiologists and Artificial Intelligence - Disease Identification and Guided Management
A study testing AI (Lucida Pi) interpretation and Radiologist interpretation in people with Prostate CA, run by University College, London.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate CA
- What is being tested?
- AI (Lucida Pi) interpretation and Radiologist interpretation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
PARADIGM Study Team contact
About this study
Official title: 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.
Read more
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.
Read the 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
- To compare the proportion of men who have clinically significant prostate cancer detected on MRI using AI ± targeted biopsy with radiologists ± targeted biopsy.
Secondary
- To compare the proportion of men who have clinically insignificant prostate cancer detected on MRI using AI ± targeted biopsy with radiologists ± targeted biopsy.
- To compare the proportion of men with non-suspicious MRIs for AI vs radiologists.
- To compare the proportion of men with indeterminately scored MRI as reported by AI vs radiologists.
- To compare the diagnostic test performance of AI vs radiologist.
- To compare the additive value of AI when used together with a radiologist interpretation (summative of all identified lesions) compared to a radiologist alone.
- 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.
- To determine the frequency of AI failures.
- To compare treatment eligibility decisions between AI and Radiologist.
- 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.
- Conditions
- Prostate CA
- Being tested
- AI (Lucida Pi) interpretation, Radiologist interpretation
- Keywords
- MRI, Prostate, Cancer, AI, Artificial Intelligence
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI (Lucida Pi) interpretationDiagnostic test
AI algorithm that will interpretate the prostate MRI
Radiologist interpretationDiagnostic test
Radiologist will interpret the prostate MRI (as per standard of care)
| Study group | Role | What they receive |
|---|---|---|
| Radiologist interpretation of MRI +/- prostate biopsy | Active comparator | Radiologist Interpretation Receives: Diagnostic Test: Radiologist interpretation |
| AI interpretation of MRI +/- prostate biopsy | Experimental | AI Interpretation Receives: Diagnostic Test: AI (Lucida Pi) interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: When biopsy results available, at an expected average of 30 days post-biopsy
Secondary outcomes (12)
Proportion of men with clinically insignificant cancer
Proportion of men with clinically insignificant cancer detected (Gleason grade 3+3/Gleason grade group 1).
Measured: When biopsy results available, at an expected average of 30 days post-biopsy
Proportion of men with non-suspicious MRIs
Proportion of men with non-suspicious MRIs for AI vs Radiologists
Measured: When MRI results available, at an expected average of 30 days post-MRI
Proportion of MRIs with indeterminate scores.
Proportion of men with indeterminately scored MRI as reported by AI vs radiologists
Measured: When MRI results available, at an expected average of 30 days post-MRI
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
Measured: When MRI results available, at an expected average of 30 days post-MRI
Diagnostic test performance characteristics (AI versus Radiologist)
Test performance characteristics for AI and Radiologists, including sensitivity, specificity, area under the receive operating characteristic curve, positive predictive value and negative predictive value.
Measured: When biopsy results available, at an expected average of 30 days post-biopsy
Diagnostic test performance characteristics (AI plus Radiologist)
Test performance characteristics of AI in combination with Radiologist (summative of all identified lesions) compared to a radiologist alone, including sensitivity, specificity, area under the receive operating characteristic curve, positive predictive value and negative predictive value.
Measured: When biopsy results available, at an expected average of 30 days post-biopsy
Diagnostic test performance characteristics (AI-assisted Radiologist)
Test performance characteristics of AI in combination with Radiologist (where the radiologist can interact with the AI system by accepting or rejecting AI-identified lesions) compared to a radiologist alone, including sensitivity, specificity, area under the receive operating characteristic curve, positive predictive value and negative predictive value.
Measured: When biopsy results available, at an expected average of 30 days post-biopsy
Significant cancer detected by peri-lesional biopsies
Proportion of patients with significant cancer detected taking into account peri-lesional biopsies of AI and Radiologist declared lesions.
Measured: When biopsy results available, at an expected average of 30 days post-biopsy
Significant cancer detected by systematic biopsies
Proportion of patients with significant cancer detected by systematic biopsies
Measured: When biopsy results available, at an expected average of 30 days post-biopsy
Frequency of AI failures
Proportion of patients where AI was unable to interpret the MRI scan
Measured: When MRI results available, at an expected average of 30 days post-MRI
Treatment eligibility decisions
Proportion of patients where treatment eligibility changed between AI and Radiologist
Measured: When biopsy results available, at an expected average of 30 days post-biopsy
Cost-efffectiveness
Cost-effectiveness of unblinded AI interpreted by the radiologist compared to radiologist alone in detecting significant prostate cancer, and AI alone vs. radiologist alone, and a 3-arm analysis considering all three.
Measured: At an expected average of 30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CAStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-person controlled, paired cohort, diagnostic evaluation study. Participants undergo two index tests and a reference test.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Lucida Medical Ltd
- Responsible party
- Sponsor
- Investigators
- Veeru Kasivisvanathan, MBBS BSc FRCS MSc PGCert PhD, Study chair, Division of Surgery and Interventional Science, University College London, UKDoug Pendse, MB ChB MD (Res) MRCS FRCR, Study chair, Department of Radiology, Universiy College London Hospitals NHS Foundation Trust, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647445
- Sponsor's protocol ID
- 338739
- Acronym
- PARADIGM
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be available at request for bona fide researchers with important research questions subject to approval by the study steering committee.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing Whether Artificial Intelligence is Non-inferior to Radiologists in the Diagnosis of Clinically Significant Prostate Cancer.
- ClinicalTrials.gov ID
- NCT07647445
- Acronym / sponsor ID
- PARADIGM / 338739
- Conditions
- Prostate CA
- Keywords
- MRI, Prostate, Cancer, AI, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Lucida Medical Ltd
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To compare the proportion of men who have clinically significant prostate cancer detected on MRI using AI ± targeted biopsy with radiologists ± targeted biopsy.
Secondary
- To compare the proportion of men who have clinically insignificant prostate cancer detected on MRI using AI ± targeted biopsy with radiologists ± targeted biopsy.
- To compare the proportion of men with non-suspicious MRIs for AI vs radiologists.
- To compare the proportion of men with indeterminately scored MRI as reported by AI vs radiologists.
- To compare the diagnostic test performance of AI vs radiologist.
- To compare the additive value of AI when used together with a radiologist interpretation (summative of all identified lesions) compared to a radiologist alone.
- 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.
- To determine the frequency of AI failures.
- To compare treatment eligibility decisions between AI and Radiologist.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Within-person controlled, paired cohort, diagnostic evaluation study. Participants undergo two index tests and a reference test.
| Arm | Type | Receives |
|---|---|---|
| Radiologist interpretation of MRI +/- prostate biopsy | Active comparator | Diagnostic Test: Radiologist interpretationRadiologist Interpretation |
| AI interpretation of MRI +/- prostate biopsy | Experimental | Diagnostic Test: AI (Lucida Pi) interpretationAI Interpretation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI (Lucida Pi) interpretationAI algorithm that will interpretate the prostate MRI | Diagnostic test | AI interpretation of MRI +/- prostate biopsy |
| Radiologist interpretationRadiologist will interpret the prostate MRI (as per standard of care) | Diagnostic test | Radiologist interpretation of MRI +/- prostate biopsy |
Primary outcome
Proportion of men with clinically significant cancer
Time frame: When biopsy results available, at an expected average of 30 days post-biopsy
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).
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. Anonymised data will be available at request for bona fide researchers with important research questions subject to approval by the study steering committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
PARADIGM Study Team contact
Veeru Kasivisvanathan, MBBS BSc FRCS MSc PGCert PhD study chair
Division of Surgery and Interventional Science, University College London, UK
Doug Pendse, MB ChB MD (Res) MRCS FRCR study chair
Department of Radiology, Universiy College London Hospitals NHS Foundation Trust, UK
Questions about this trial
What is this clinical trial studying?
A study testing AI (Lucida Pi) interpretation and Radiologist interpretation in people with Prostate CA, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ng Alexander, MBBS BSc (Hons) (+44 0207 679 5057, alexander.ng@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of men with clinically significant cancer (time frame: When biopsy results available, at an expected average of 30 days post-biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.