NCT05228197Active, not recruiting
Imperial Prostate 6 - Cancer Histology Artificial Intelligence Reliability Study.
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.
Source: ClinicalTrials.gov · Last updated 22 Jan 2025
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 750 (estimated)
- First submitted
- 24 Sept 2021
- Start date
- 11 Mar 2022
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- Imperial College London
- Diseases
- Prostate cancer
- NCT number
- NCT05228197
What you commit to
- Study type: Observational
- Planned participants: 750
- From 11 Mar 2022 to the primary completion date, 31 Aug 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Unwilling or unable to give consent.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Coventry and Warwickshire NHS Trust Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
| Chelsea and Westminster Hospital Nhs Foundation Trust - Chelsea Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Chelsea and Westminster Hospital Nhs Foundation Trust - West Middlesex Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.