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

29 juni 2026 bijgewerkt door: University College, London

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

500

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Radiologist interpretation of MRI +/- prostate biopsy
Radiologist Interpretation
Diagnostische toets: Radiologist interpretation
Radiologist will interpret the prostate MRI (as per standard of care)
Experimenteel: AI interpretation of MRI +/- prostate biopsy
AI Interpretation
Diagnostische toets: AI (Lucida Pi) interpretation
AI algorithm that will interpretate the prostate MRI

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of men with clinically significant cancer
Tijdsspanne: 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).
When biopsy results available, at an expected average of 30 days post-biopsy

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of men with clinically insignificant cancer
Tijdsspanne: When biopsy results available, at an expected average of 30 days post-biopsy
Proportion of men with clinically insignificant cancer detected (Gleason grade 3+3/Gleason grade group 1).
When biopsy results available, at an expected average of 30 days post-biopsy
Proportion of men with non-suspicious MRIs
Tijdsspanne: When MRI results available, at an expected average of 30 days post-MRI
Proportion of men with non-suspicious MRIs for AI vs Radiologists
When MRI results available, at an expected average of 30 days post-MRI
Proportion of MRIs with indeterminate scores.
Tijdsspanne: When MRI results available, at an expected average of 30 days post-MRI
Proportion of men with indeterminately scored MRI as reported by AI vs radiologists
When MRI results available, at an expected average of 30 days post-MRI
Agreement between AI and Radiologist in score of suspicion
Tijdsspanne: When MRI results available, at an expected average of 30 days post-MRI
Compare the proportion of MRIs with concordant scores between AI and Radiologist in score of suspicion
When MRI results available, at an expected average of 30 days post-MRI
Diagnostic test performance characteristics (AI versus Radiologist)
Tijdsspanne: When biopsy results available, at an expected average of 30 days post-biopsy
Test performance characteristics for AI and Radiologists, including sensitivity, specificity, area under the receive operating characteristic curve, positive predictive value and negative predictive value.
When biopsy results available, at an expected average of 30 days post-biopsy
Diagnostic test performance characteristics (AI plus Radiologist)
Tijdsspanne: When biopsy results available, at an expected average of 30 days post-biopsy
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.
When biopsy results available, at an expected average of 30 days post-biopsy
Diagnostic test performance characteristics (AI-assisted Radiologist)
Tijdsspanne: When biopsy results available, at an expected average of 30 days post-biopsy
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.
When biopsy results available, at an expected average of 30 days post-biopsy
Significant cancer detected by peri-lesional biopsies
Tijdsspanne: When biopsy results available, at an expected average of 30 days post-biopsy
Proportion of patients with significant cancer detected taking into account peri-lesional biopsies of AI and Radiologist declared lesions.
When biopsy results available, at an expected average of 30 days post-biopsy
Significant cancer detected by systematic biopsies
Tijdsspanne: When biopsy results available, at an expected average of 30 days post-biopsy
Proportion of patients with significant cancer detected by systematic biopsies
When biopsy results available, at an expected average of 30 days post-biopsy
Frequency of AI failures
Tijdsspanne: When MRI results available, at an expected average of 30 days post-MRI
Proportion of patients where AI was unable to interpret the MRI scan
When MRI results available, at an expected average of 30 days post-MRI
Treatment eligibility decisions
Tijdsspanne: When biopsy results available, at an expected average of 30 days post-biopsy
Proportion of patients where treatment eligibility changed between AI and Radiologist
When biopsy results available, at an expected average of 30 days post-biopsy
Cost-efffectiveness
Tijdsspanne: At an expected average of 30 days post-intervention
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.
At an expected average of 30 days post-intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University College, London

Medewerkers

Lucida Medical Ltd

Onderzoekers

  • Studie stoel: Veeru Kasivisvanathan, MBBS BSc FRCS MSc PGCert PhD, Division of Surgery and Interventional Science, University College London, UK
  • Studie stoel: Doug Pendse, MB ChB MD (Res) MRCS FRCR, Department of Radiology, Universiy College London Hospitals NHS Foundation Trust, UK

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 januari 2029

Studie voltooiing (Geschat)

1 januari 2029

Studieregistratiedata

Eerst ingediend

9 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 juni 2026

Eerst geplaatst (Werkelijk)

15 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

29 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 338739

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Anonymised data will be available at request for bona fide researchers with important research questions subject to approval by the study steering committee.

IPD-tijdsbestek voor delen

Data will become available 1 year after publication of the main study results.

IPD-toegangscriteria voor delen

A study steering committee will review all requests for access to the data and will make decisions on whether or not to grant access to bona fide researchers based on the importance of the research question being asked, ensuring analysis is non overlapping with existing analyses and planned analyses.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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