Prostate cancer Cancer
Conditions
Interventions
Prostate specimens from subjects undergoing radical prostatectomy (RP) will be stained with a fluorescent dye (Histolog Dip) and then be scanned on a digital fluorescent confocal microscope (FCM) know
Sponsors
Imperial College Healthcare NHS Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men aged >/=18 years 2. Men undergoing radical prostatectomy at Imperial College Healthcare NHS Trust during the study period 3. Nerve sparing and non-nerve sparing radical prostatectomy cases
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 09/05/2024: 1. Men who do not consent for ex vivo tissue research 2. Men who are listed for salvage prostatectomy and had a previous prostate cancer treatment (radiotherapy, brachytherapy, focal therapy) _____ Previous exclusion criteria: 1. Men who do not consent for ex vivo tissue research through Imperial College Healthcare Tissue Bank (ICHTB) 2. Men who are listed for salvage prostatectomy and had a previous prostate cancer treatment (radiotherapy, brachytherapy, focal therapy) 3. Men enrolled in concurrent clinical trials requiring ex vivo prostatic tissue for research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of digital FCM measured using the Histolog Scanner in detecting clinically significant prostate cancer at surgical margins at radical prostatectomy compared to traditional H&E histopathology (reference standard). Measures used to assess accuracy will be sensitivity, specificity, positive and negative predictive value. Clinically significant cancer is defines as Gleason score >/= 7 (ISUP Grade Group >/=2). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensitivity, specificity, positive and negative predictive value of digital FCM for detection of cancer at surgical margins, with traditional H&E histopathology as the reference standard, on a per-image/margin level 2. Area under the receiver operating characteristic curve (AUC) for cancer detection of digital FCM with traditional H&E histopathology as the reference standard 3. Agreement of digital FCM with the pathology report for cancer length at margin (mm) on a margin and patient level 4. Agreement of digital FCM with the pathology report for cancer grade at margin (mm) on a margin and patient level 5. Cohen’s kappa coefficient for agreement between readers (two individual histopathologists, histopathologist vs trainee histopathologist, histopathologist vs urologist) | — |
Countries
England, United Kingdom
Contacts
Public ContactNikhil Mayor
Outcome results
None listed