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

29. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

500

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Radiologist interpretation of MRI +/- prostate biopsy
Radiologist Interpretation
Diagnostisk test: Radiologist interpretation
Radiologist will interpret the prostate MRI (as per standard of care)
Eksperimentell: AI interpretation of MRI +/- prostate biopsy
AI Interpretation
Diagnostisk test: AI (Lucida Pi) interpretation
AI algorithm that will interpretate the prostate MRI

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of men with clinically significant cancer
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of men with clinically insignificant cancer
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University College, London

Samarbeidspartnere

Lucida Medical Ltd

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. januar 2029

Studiet fullført (Antatt)

1. januar 2029

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

9. juni 2026

Først lagt ut (Faktiske)

15. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 338739

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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