Imperial Prostate 6 - Cancer Histology Artificial Intelligence Reliability Study.

NCT05228197 | Active Not Recruiting DMC

• 1 other identifier: 21CX6823
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 6

Brief Summary

The primary objective is to determine whether the Galen Prostate AI system has sufficient diagnostic accuracy and health economic value to be used for triage of pathology slides within the NHS.

Conditions

Prostatic Neoplasms

Keywords

Prostate Cancer; Prostate-Specific Antigen; Artificial Intelligence; Histology

Outcome Measures

Primary Outcomes (3)

• Galen Prostate AI

  Sensitivity, specificity, positive and negative predictive value of Galen Prostate AI on a patient basis for prostate cancer rated Gleason score 7 (ISUP Grade Group \>/=2) or greater by consensus pathology review.

  Maximum 6 weeks following enrolment

• Composite Health Outcome (Cost-Consequence Analysis)

  Includes all the relevant cost and consequences for the Ibex-AI and comparator. Costs: medical equipment, mean cost per diagnosis, primary and secondary care appointments, healthcare professionals' costs, cost of the diagnostic tests and of follow-up testing. Consequences: test accuracy, diagnostic yield, and therapeutic yield.

  Maximum 6 weeks following enrolment

• Composite Health Outcome (Cost-Utility Analysis)

  Will be presented in the form of an Incremental Cost-Effectiveness Ratio (ICER), a ratio of 'extra cost per extra unit of health outcome' for the intervention vs the comparator. Costs: medical equipment, mean cost per diagnosis, primary and secondary care appointments, healthcare professionals' costs, cost of the diagnostic tests and of follow-up testing, implementation costs of adopting the intervention in the NHS, cost of treatment, treatment of adverse effects from the test or treatment, and any monitoring needed before or after the treatment. Health outcomes: Quality-adjusted life years (QALY). QALYs will be calculated by estimating the years of life remaining for a patient following diagnosis and weighting each year with a quality-of-life score (EQ-5D questionnaire).

  Maximum 6 weeks following enrolment

Secondary Outcomes (12)

• Galen Prostate AI (1)

  Maximum 6 weeks following enrolment

• Galen Prostate AI (2)

  Maximum 6 weeks following enrolment

• Galen Prostate AI (3)

  Maximum 6 weeks following enrolment

• Galen Prostate AI (4)

  Maximum 6 weeks following enrolment

• Galen Prostate AI (5)

  Maximum 6 weeks following enrolment

Study Arms (2)

Calibration Stage

Patients referred to hospital urology departments by their GP due to a clinical suspicion of prostate cancer (elevated serum prostate specific antigen \[PSA\], abnormal feeling prostate on rectal examination). These patients are normally recommended to undergo a prostate MRI as part of standard care. Patients will need to meet the Inclusion/Exclusion criteria but in addition, purposive identification of cases with a variety and representative sample of different pathology features are needed for this stage (e.g. normal glands, cancer glands, high-grade PIN, inflammation).

Diagnostic Test: Biopsy & Imaging

Validation Stage

Patients referred to hospital urology departments by their GP due to a clinical suspicion of prostate cancer (elevated serum prostate specific antigen \[PSA\], abnormal feeling prostate on rectal examination). These patients are normally recommended to undergo a prostate MRI as part of standard care. Patients will need to meet the Inclusion/Exclusion.

Diagnostic Test: Biopsy & Imaging

Interventions

Biopsy & Imaging DIAGNOSTIC_TEST

H\&E stained prostate biopsy slides from standard of care treatment

Calibration Stage; Validation Stage

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Either cis-male gender or trans-female gender with no prior hormone use at all.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population is patients referred for a prostate biopsy as a result of an elevated serum PSA or abnormal digital rectal exam, who are undergoing or have already undergone prostate biopsies.

You may qualify if:

• Patients with a prostate (either cis-male gender or trans-female gender with no prior hormone use at all).
• Age 18 years or above.
• Undergoing prostate biopsy as a result of an elevated serum PSA or abnormal digital rectal exam, who have undergone a pre-biopsy multi-parametric MRI and advised to undergo prostate biopsies.
• (Please note: the Calibration stage requires patients who have already undergone a biopsy and the pathology has been processed over the prior 0 to 12 months).

You may not qualify if:

• Unwilling or unable to give consent.
• Any duration or type or dose of androgen deprivation therapy in the 6 months prior to screening.
• Any prior radiotherapy to the prostate or pelvis (including the prostate) or ablation or chemical treatment of the prostate for treating cancer: these types of treatment affect the anatomy of prostate tissue microstructure for which Galen Prostate AI is not currently validated. NB: any treatment for benign enlargement of the prostate is permitted.

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (6)

University Hospitals Coventry and Warwickshire Nhs Trust

Coventry, United Kingdom

Location

Chelsea and Westminster Hospital Nhs Foundation Trust - Chelsea

London, United Kingdom

Location

Chelsea and Westminster Hospital Nhs Foundation Trust - West Middlesex

London, United Kingdom

Location

Imperial College Healthcare Nhs Trust

London, United Kingdom

Location

University College London Hospitals Nhs Foundation Trust

London, United Kingdom

Location

University Hospital Southampton Nhs Foundation Trust

Southampton, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

H\&E stained histology human tissue

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hashim U Ahmed

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: February 8, 2022
• Study Start: March 11, 2022
• Primary Completion: August 31, 2024
• Study Completion: April 30, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)