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Examining the impacts of pathologists using the assistance of computer technology (artificial intelligence software) on the diagnosis of prostate cancer biopsies

Driving improvements for prostate biopsy patients using Paige Prostate AI software to determine the benefits of pathologist-led diagnosis before and after the deployment of AI assistance (ARTICULATE PRO)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN91685765
Enrollment
1500
Registered
2022-08-25
Start date
2022-04-28
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer Malignant neoplasm of prostate

Interventions

Digital images of histopathology slides prepared from prostate core needle biopsy tissue for primary diagnosis are viewed by specialist histopathologists according to the standard diagnostic pathway f

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: All patients undergoing prostate biopsy for suspected prostate cancer

Exclusion criteria

Exclusion criteria: 1. Patients who have opted out of clinical care via the existing 'consent to examination or treatment policy' 2. Non-prostate biopsy tissue

Design outcomes

Primary

MeasureTime frame
Immediate changes to diagnostic reports of prostate biopsy cases and the corresponding immediate changes in patients' clinical management due to the use of Paige Prostate assistance, as measured by cancer/ASAP identification, Gleason grade 4 identification, tumour burden including length, number of involved cores, treatment pathway recommendation as determined by a multidisciplinary team (MDT).

Secondary

MeasureTime frame
1. Impact of Paige Prostate on resource utilisation, as measured by time and tests required for pathologists to review prostate biopsy cases and make clinical recommendations at MDT, and as measured by labour landscape in terms of staff and workloads. Comparison of resource utilisation across two separate consecutive cohorts, one without Paige Prostate, and one after Paige Prostate deployment. 2. Impact of Paige Prostate on patient management, as modeled using health economics and current patient pathways, their co-morbidities and their costs, and the diagnostic discrepancies comparing unassisted and assisted diagnoses over the lifetime of a prostate cancer patient receiving biopsy. 3. Impact of Paige Prostate on the experiences of histopathologists, urologists and patients, as measured by survey and qualitative methods on prostate biopsy diagnosis and treatment selection challenges, comparing standard of care immediate experience at baseline to experience ascertained as pathologists go through the learning curve of adopting AI over the course of this study.

Countries

England, United Kingdom

Contacts

Public ContactMonica Dolton
monica.dolton@nds.ox.ac.uk+44 (0)1865 612273

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 9, 2026