Status:
ACTIVE_NOT_RECRUITING
Imperial Prostate 6 - Cancer Histology Artificial Intelligence Reliability Study.
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
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.
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 160,000-200,0...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT05228197
Start Date
March 11 2022
End Date
April 30 2025
Last Update
January 22 2025
Active Locations (6)
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1
University Hospitals Coventry and Warwickshire Nhs Trust
Coventry, United Kingdom
2
Chelsea and Westminster Hospital Nhs Foundation Trust - Chelsea
London, United Kingdom
3
Chelsea and Westminster Hospital Nhs Foundation Trust - West Middlesex
London, United Kingdom
4
Imperial College Healthcare Nhs Trust
London, United Kingdom