Prostate MRI Analysis by Radiologists and Artificial Inte... | NCT07647445

Studies
Prostate MRI Analysis by Radiologists and Artificial Intelligence - Disease Identification and Guided Management

NCT07647445

Sponsor

University College, London

Status

Not yet recruiting

Last Update Posted

Jun 30, 2026Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Prostate CA

Interventions

AI (Lucida Pi) interpretation
Radiologist interpretation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2026Estimated

Primary Completion Date

Jan 2029Estimated

Completion Date

Jan 2029Estimated

First Submitted Date

Jun 9, 2026

First Submission Date that Met QC Criteria

Jun 9, 2026

First Posted Date

Jun 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2026

Last Update Posted Date

Jun 30, 2026Actual

Name	Class
Lucida Medical Ltd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiologist interpretation of MRI +/- prostate biopsy	Active Comparator	Radiologist Interpretation	Diagnostic Test: Radiologist interpretation
AI interpretation of MRI +/- prostate biopsy	Experimental	AI Interpretation	Diagnostic Test: AI (Lucida Pi) interpretation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AI (Lucida Pi) interpretation	Diagnostic Test	AI algorithm that will interpretate the prostate MRI	AI interpretation of MRI +/- prostate biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	When biopsy results available, at an expected average of 30 days post-biopsy

Secondary Outcomes

Measure	Description	Time Frame
Proportion of men with clinically insignificant cancer	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ng Alexander, MBBS BSc (Hons)	Contact	+44 0207 679 5057		alexander.ng@ucl.ac.uk
PARADIGM Study Team	Contact			med.paradigm@ucl.ac.uk

Overall Officials

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

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

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

Access Criteria

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.

URL

Not provided

ID	Term
D009369	Neoplasms

Masking Info

Masking

Single

Masking Description

AI and Radiologist interpreting the MRI for suspicion of prostate cancer are blinded to each other. After both reports are produced, they are unblinded, and a merged report is produced. All bioopsies are conducted as a result of both the AI and Radiologist interpretation, and as a result, lesions will be identified as AI and Radiologist positive, or negative, as appropriate. Diagnostic accuracy will be assessed against histology findings.

Who Masked

Care Provider