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

9. Juni 2026 aktualisiert von: 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 interpretating 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. f 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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 evidnece trial in participants referred to hospital with a clinical suspicion of prostate cancer.

Studientyp

Interventionell

Einschreibung (Geschätzt)

500

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Radiologist interpretation of MRI +/- prostate biopsy
Radiologist Interpretation
Diagnosetest: Radiologist interpretation
Radiologist will interpret the prostate MRI (as per standard of care)
Experimental: AI interpretation of MRI +/- prostate biopsy
AI Interpretation
Diagnosetest: AI (Lucida Pi) interpretation
AI algorithm that will interpretate the prostate MRI

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of men with clinically significant cancer
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of men with clinically insignificant cancer
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University College, London

Mitarbeiter

Lucida Medical Ltd

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Januar 2029

Studienabschluss (Geschätzt)

1. Januar 2029

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juni 2026

Zuerst gepostet (Tatsächlich)

15. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 338739

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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