Prostatic Neoplasms Clinical Trial
— IP6-CHAIROSOfficial 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.
NCT number | NCT05228197 |
Other study ID # | 21CX6823 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 11, 2022 |
Est. completion date | December 31, 2024 |
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.
Status | Recruiting |
Enrollment | 750 |
Est. completion date | December 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals Coventry and Warwickshire Nhs Trust | Coventry | |
United Kingdom | Chelsea and Westminster Hospital Nhs Foundation Trust - Chelsea | London | |
United Kingdom | Chelsea and Westminster Hospital Nhs Foundation Trust - West Middlesex | London | |
United Kingdom | Imperial College Healthcare Nhs Trust | London | |
United Kingdom | University College London Hospitals Nhs Foundation Trust | London | |
United Kingdom | University Hospital Southampton Nhs Foundation Trust | Southampton |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | Maximum 6 weeks following enrolment | |
Secondary | Galen Prostate AI (2) | Sensitivity, specificity, positive and negative predictive value of Galen Prostate AI on a patient basis for all prostate cancer. | Maximum 6 weeks following enrolment | |
Secondary | 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). | Maximum 6 weeks following enrolment | |
Secondary | 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). | Maximum 6 weeks following enrolment | |
Secondary | Galen Prostate AI (5) | Agreement of Galen Prostate AI with histology reported percent Gleason Grade pattern 4. | Maximum 6 weeks following enrolment | |
Secondary | 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. | Maximum 6 weeks following enrolment | |
Secondary | Galen Prostate AI (7) | Cancer area (mm2) by slide (Galen Prostate AI only). | Maximum 6 weeks following enrolment | |
Secondary | Galen Prostate AI (8) | Uncalibrated Galen Prostate tool (software) assessed using above primary and secondary metrics. | Maximum 6 weeks following enrolment | |
Secondary | Pathology Reporting | Volume of local pathology reporting (histology slides) on above primary and secondary metrics compared to independent pathology reporting. | Maximum 6 weeks following enrolment | |
Secondary | 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. | Maximum 6 weeks following enrolment | |
Secondary | 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. | Maximum 6 weeks following enrolment | |
Secondary | Cost-Effectiveness | Cost-effectiveness of Galen Prostate system within the NHS (QALYs questionnaire). | Maximum 6 weeks following enrolment |
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