Prostatic NeoplasmsIP6-CHAIROSNCT05228197
Imperial Prostate 6 - Cancer Histology Artificial Intelligence Reliability Study.
An observational study of Prostatic Neoplasms, run by Imperial College London at 6 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Biopsy & Imaging
- How many people
- 750 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 11 Mar 2022to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
University Hospitals Coventry and Warwickshire Nhs Trust
Coventry
Chelsea and Westminster Hospital Nhs Foundation Trust - Chelsea
London
Chelsea and Westminster Hospital Nhs Foundation Trust - West Middlesex
London
Imperial College Healthcare Nhs Trust
London
University College London Hospitals Nhs Foundation Trust
London
University Hospital Southampton Nhs Foundation Trust
Southampton
About this study
Official title: A Study to Assess the Clinical and Cost-effectiveness of the Galen Prostate Artificial Intelligence Histology System in Diagnosing Clinically Important Prostate Cancer on Prostate Biopsy Tissue.
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.
Read the detailed description
In the UK, about 80-100,000 men every year undergo prostate biopsy to diagnose prostate cancer. This equates to approximately 4 million histology slides; this is estimated to increase to 160,000-200,000 men and up to 6 million slides by 2030 due to rising numbers of men being tested for prostate cancer.
Health Education England and the Royal College of Pathology point to a significant pathology work-force shortage with only 3% of departments having adequate staffing levels and a 10% vacancy rate filled by locums costing £26M every year. By 2021, there will be a 3% decrease of the pathology consultant workforce (40 full-time pathologists); a period of time in which other specialties are expected to see a 13% increase. However, to meet the rising numbers of referrals to pathology departments, it is projected that there will need to be a 3-5% annual growth in the number of pathologists.
Inter-observer variability can occur between pathologists in terms of reporting a diagnosis of clinically important and clinically unimportant prostate cancer by as much as 20% although the differences are smaller when highly expert uro-pathologists are compared. This can lead to inappropriate management of cases.
Galen Prostate AI is a CE-marked deep learning AI-algorithm for prostate needle biopsies that can identify cell types, tissue structures and morphological features for cancer diagnosis. The technology is based on multi-layered convolutional neural networks (CNNs) designed for image classification in which whole-slide imaging is analysed for the detection of tissue areas and then benign versus cancer versus other pathology classification. Compared to almost all competitors, Galen Prostate AI has been tested in ~10 times more tissue samples. Further, Galen Prostate AI is the only algorithm that extends beyond cancer detection/grading to other clinically relevant features (e.g., perineural invasion, high-grade prostatic intraepithelial neoplasia [PIN], inflammation). This AI-algorithm is believed to be the only one in routine clinical deployment - demonstrating technical feasibility and with proven clinical utility.
The proposed study will perform validation in the NHS, for the first time. It is important to stress that this type of algorithm has never been tested on a UK-based population, and in particular, a population that includes a cohort of MRI targeted biopsies, which is now the new diagnostic strategy as it detects clinically relevant prostate cancer in higher percentages than the routine systematic biopsy.
The study is the first and only to address the performance of the AI-based prostate algorithm that extends beyond cancer detection and Gleason grading, by measuring amount of cancer and detecting clinically meaningful features such as perineural invasion in addition to multiple benign structures (e.g. HGPIN, atrophy, inflammation). Given the clinical relevance for such features in the diagnosis process, a study addressing their validation and performance is not only novel, but critical for implementation in routine clinical use.
- Conditions
- Prostatic Neoplasms
- Being tested
- Biopsy & Imaging
- Keywords
- Prostate Cancer, Prostate-Specific Antigen, Artificial Intelligence, Histology
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy & ImagingDiagnostic test
H\&E stained prostate biopsy slides from standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Diagnostic Test: Biopsy & Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Maximum 6 weeks following enrolment
Secondary outcomes (12)
Galen Prostate AI (1)
Sensitivity, specificity, positive and negative predictive value of Galen Prostate AI on a slide/biopsy grouping basis (weighted by patient) for prostate cancer rated Gleason score >/=7 (ISUP Grade Group >/=2) by consensus pathology review.
Measured: Maximum 6 weeks following enrolment
Galen Prostate AI (2)
Sensitivity, specificity, positive and negative predictive value of Galen Prostate AI on a patient basis for all prostate cancer.
Measured: Maximum 6 weeks following enrolment
Galen Prostate AI (3)
Area under the receiver operating characteristic curve (AUC) at the patient and slide/biopsy grouping levels for any cancer and clinically significant prostate cancer defined by any Gleason score >/=7 (ISUP Grade Group >/=2).
Measured: Maximum 6 weeks following enrolment
Galen Prostate AI (4)
Agreement of Galen Prostate AI with pathology report for cancer length (mm) on slide/biopsy grouping level and patient level (maximum cancer length).
Measured: Maximum 6 weeks following enrolment
Galen Prostate AI (5)
Agreement of Galen Prostate AI with histology reported percent Gleason Grade pattern 4.
Measured: Maximum 6 weeks following enrolment
Galen Prostate AI (6)
Agreement of Galen Prostate AI with histology reported Gleason score or Grade Group (GG) categories at slide/biopsy grouping level and patient level.
Measured: Maximum 6 weeks following enrolment
Galen Prostate AI (7)
Cancer area (mm2) by slide (Galen Prostate AI only).
Measured: Maximum 6 weeks following enrolment
Galen Prostate AI (8)
Uncalibrated Galen Prostate tool (software) assessed using above primary and secondary metrics.
Measured: Maximum 6 weeks following enrolment
Pathology Reporting
Volume of local pathology reporting (histology slides) on above primary and secondary metrics compared to independent pathology reporting.
Measured: Maximum 6 weeks following enrolment
Databank Link
Databank of scanned high-resolution histology slides and MRI DICOM images linked to clinical parameters for future academic and commercial research into development and validation of diagnostic and prognostic tools for prostate diseases.
Measured: Maximum 6 weeks following enrolment
Consent to Linkage
Number of participants consenting to linkage to national databases for longitudinal healthcare outcomes reporting and correlation to clinical, MR-imaging and histological parameters collected in this study.
Measured: Maximum 6 weeks following enrolment
Cost-Effectiveness
Cost-effectiveness of Galen Prostate system within the NHS (QALYs questionnaire).
Measured: Maximum 6 weeks following enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start11 Mar 2022
- Primary completion31 Aug 2024
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Hashim U Ahmed, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228197
- Sponsor's protocol ID
- 21CX6823
- Acronym
- IP6-CHAIROS
- Status last verified
- Jan 2025
- First submitted
- 24 Sep 2021
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Clinical and Cost-effectiveness of the Galen Prostate Artificial Intelligence Histology System in Diagnosing Clinically Important Prostate Cancer on Prostate Biopsy Tissue.
- ClinicalTrials.gov ID
- NCT05228197
- Acronym / sponsor ID
- IP6-CHAIROS / 21CX6823
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate Cancer, Prostate-Specific Antigen, Artificial Intelligence, Histology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the UK, about 80-100,000 men every year undergo prostate biopsy to diagnose prostate cancer. This equates to approximately 4 million histology slides; this is estimated to increase to 160,000-200,000 men and up to 6 million slides by 2030 due to rising numbers of men being tested for prostate cancer.
Health Education England and the Royal College of Pathology point to a significant pathology work-force shortage with only 3% of departments having adequate staffing levels and a 10% vacancy rate filled by locums costing £26M every year. By 2021, there will be a 3% decrease of the pathology consultant workforce (40 full-time pathologists); a period of time in which other specialties are expected to see a 13% increase. However, to meet the rising numbers of referrals to pathology departments, it is projected that there will need to be a 3-5% annual growth in the number of pathologists.
Inter-observer variability can occur between pathologists in terms of reporting a diagnosis of clinically important and clinically unimportant prostate cancer by as much as 20% although the differences are smaller when highly expert uro-pathologists are compared. This can lead to inappropriate management of cases.
Galen Prostate AI is a CE-marked deep learning AI-algorithm for prostate needle biopsies that can identify cell types, tissue structures and morphological features for cancer diagnosis. The technology is based on multi-layered convolutional neural networks (CNNs) designed for image classification in which whole-slide imaging is analysed for the detection of tissue areas and then benign versus cancer versus other pathology classification. Compared to almost all competitors, Galen Prostate AI has been tested in ~10 times more tissue samples. Further, Galen Prostate AI is the only algorithm that extends beyond cancer detection/grading to other clinically relevant features (e.g., perineural invasion, high-grade prostatic intraepithelial neoplasia [PIN], inflammation). This AI-algorithm is believed to be the only one in routine clinical deployment - demonstrating technical feasibility and with proven clinical utility.
The proposed study will perform validation in the NHS, for the first time. It is important to stress that this type of algorithm has never been tested on a UK-based population, and in particular, a population that includes a cohort of MRI targeted biopsies, which is now the new diagnostic strategy as it detects clinically relevant prostate cancer in higher percentages than the routine systematic biopsy.
The study is the first and only to address the performance of the AI-based prostate algorithm that extends beyond cancer detection and Gleason grading, by measuring amount of cancer and detecting clinically meaningful features such as perineural invasion in addition to multiple benign structures (e.g. HGPIN, atrophy, inflammation). Given the clinical relevance for such features in the diagnosis process, a study addressing their validation and performance is not only novel, but critical for implementation in routine clinical use.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calibration Stage | – | Diagnostic Test: Biopsy & ImagingPatients 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). |
| Validation Stage | – | Diagnostic Test: Biopsy & ImagingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy & ImagingH\&E stained prostate biopsy slides from standard of care treatment | Diagnostic test | Calibration Stage, Validation Stage |
Primary outcome
Galen Prostate AI
Time frame: Maximum 6 weeks following enrolment
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.
Composite Health Outcome (Cost-Consequence Analysis)
Time frame: Maximum 6 weeks following enrolment
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.
Composite Health Outcome (Cost-Utility Analysis)
Time frame: Maximum 6 weeks following enrolment
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).
12 secondary outcomes
Galen Prostate AI (1)
Time frame: Maximum 6 weeks following enrolment
Galen Prostate AI (2)
Time frame: Maximum 6 weeks following enrolment
Galen Prostate AI (3)
Time frame: Maximum 6 weeks following enrolment
Galen Prostate AI (4)
Time frame: Maximum 6 weeks following enrolment
Galen Prostate AI (5)
Time frame: Maximum 6 weeks following enrolment
Galen Prostate AI (6)
Time frame: Maximum 6 weeks following enrolment
Galen Prostate AI (7)
Time frame: Maximum 6 weeks following enrolment
Galen Prostate AI (8)
Time frame: Maximum 6 weeks following enrolment
Pathology Reporting
Time frame: Maximum 6 weeks following enrolment
Databank Link
Time frame: Maximum 6 weeks following enrolment
Consent to Linkage
Time frame: Maximum 6 weeks following enrolment
Cost-Effectiveness
Time frame: Maximum 6 weeks following enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hashim U Ahmed principal investigator
Imperial College London
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Imperial College London at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Galen Prostate AI (time frame: Maximum 6 weeks following enrolment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.