Clinical trial · Observational
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.
NCT05228197CI-TRIAL-00084957IP6-CHAIROSactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy & Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Calibration Stage
- description
- 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).
- interventionNames
- Diagnostic Test: Biopsy & Imaging
- label
- Validation Stage
- description
- 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.
- interventionNames
- Diagnostic Test: Biopsy & Imaging
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.