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H&E and IHC correlates of early surveillance reclassification in localized prostate cancer

Principal Investigator

Name
MOHAMED OMAR

Degrees
M.B.B.Ch

Institution
Cedars-Sinai Medical Center

Position Title
Assistant Professor

Email
mohamed.omar@csmc.edu

About this CDAS Project

Study
EPPT (Learn more about this study)

Project ID
EPPT-5

Initial CDAS Request Approval
Jul 23, 2026

Title
H&E and IHC correlates of early surveillance reclassification in localized prostate cancer

Summary
Active surveillance is standard for low-risk prostate cancer and is increasingly considered for selected men with Grade Group 2 disease. A key unresolved problem is identifying men whose diagnostic biopsy appears favorable but whose tumor biology or subsequent biopsy behavior suggests higher risk. We are developing H&E-based computational pathology methods to estimate adverse pathology and surveillance unsuitability from diagnostic prostate biopsy tissue.

The UWI2013-00-01 Pomegranate Prostate study provides a unique active-surveillance biospecimen resource with prostate biopsy tissue collected at baseline and week 52, together with clinical, PSA, biopsy, intervention, and tissue biomarker data. We request a small subset of unstained FFPE prostate biopsy slides from available baseline and week-52 tissue blocks to perform tissue-sparing immunohistochemical validation of H&E-derived risk features. Candidate markers will include proliferation and prostate cancer biology markers such as Ki-67, PTEN, ERG, p53, and selected basal-cell markers if needed to support evaluation of intraductal/cribriform-associated architecture.

The primary analysis will test whether baseline H&E-derived morphology and IHC markers are associated with subsequent biopsy reclassification or progression-related features at week 52, including upgrading, increased tumor volume, PSA kinetics, or other available surveillance outcomes. Secondary analyses will evaluate whether H&E/IHC features change between baseline and week 52 and whether treatment arm should be accounted for in interpreting tissue-marker changes. This study will serve as a pilot active-surveillance biopsy validation cohort, complementing larger biopsy-prostatectomy datasets used to study biopsy-occult adverse pathology in Grade Group 2 disease.

Aims

* Aim 1. Define surveillance-reclassification outcomes in the UWI Pomegranate Prostate study. We will use available clinical, PSA, biopsy, and trial data to define early surveillance-reclassification endpoints, including biopsy upgrading, increased tumor volume, PSA kinetics, or other progression-related variables available at baseline and week 52.
* Aim 2. Perform tissue-sparing IHC validation of H&E-derived biopsy risk features. We will use a small number of unstained FFPE prostate biopsy slides from baseline and week 52 to assay selected markers of prostate cancer aggressiveness and architecture, including candidate markers such as Ki-67, PTEN, ERG, p53, and basal-cell markers if feasible.
* Aim 3. Integrate H&E morphology, IHC markers, and longitudinal AS outcomes. We will test whether H&E-derived computational pathology features and IHC readouts from baseline biopsy tissue are associated with week-52 biopsy reclassification or progression-related features, adjusting for treatment arm where appropriate.

Collaborators

MOHAMED OMAR Cedars-Sinai Medical Center