# Prognostic and Predictive Digital Tissue Image Assay for Prostate Cancer

> **NIH NIH R01** · EMORY UNIVERSITY · 2023 · $627,645

## Abstract

PROJECT SUMMARY: There were >34,000 PCa-related deaths in 2020 in the US alone. Definitive treatment
includes Radical prostatectomy (RP) or radiotherapy (RT) with long term androgen-suppression therapy (ADT).
These have been shown to be effective treatments for organ-confined PCa and have been demonstrated to
reduce the risk of death from PCa. In 38-52% of cases, however, advanced disease with potentially poor
prognosis is found on tissue pathology. A number of recent clinical trials have shown the benefit of adjuvant
therapy in select PCa patients post-RP or RT. However, it is critical to identify those PCa patients who following
definitive therapy (surgery or radiation) are at high-risk for recurrence or metastasis and thus will benefit from
adjuvant therapy versus patients who will not and hence may be spared the morbidity and cost of therapy.
 Recognizing the significance of this unmet clinical need, in 2018 the NCCN guidelines for PCa were
modified to include the Decipher Score, a prognostic molecular gene-based test to identify the likelihood of
metastasis following surgery. We have developed our own "Integrated Risk Score" (IRiS) image classifier that
(npj Precison Onc, In Press14) combines computer extracted morphologic glandular features from H&E tissue
slides of the tumor. IRiS stratified PCa patients (N>900, 6 sites) based on their time to biochemical recurrence
(BCR) into low- and high-risk groups (p<0.001; HR=2.44). Further, IRiS when combined with pre-op PSA and
Gleason grade outperformed Decipher in predicting BCR in N=173 patients (p<0.001; HR=3.23 vs HR=2.76).
 In this R01, we will validate IRiS as (1) prognostic of BCR and risk of metastasis as well as (2)
predictive of the added benefit of additional chemotherapy following definitive therapy (surgery or radiation) in
PCa. In a recent paper in Clin Cancer Res, we identified IRiS specific prognostic features for African American
(AA) men with PCa. We will build on these findings to develop population specific IRiS models for PCa. We will
also further optimize IRiS by including (1) features of stromal and cribriform morphology, (2) develop population
specific IRiS models for different ethnic groups, and (3) complement IRiS with clinico-pathological features. To
validate IRiS as predictive of benefit of adjuvant therapy, we need access to randomized clinical trial tissue slide
images involving PCa patients treated with definitive therapy alone (surgery or ADT+radiation) and definitive
therapy+ adj. chemo. The STAMPEDE and RTOG-0521 trials fit these criteria; we have secured approval to
access tissue slide images from these trials. To make the tool widely available, IRiS will be integrated into
PathPresenter, a digital pathology viewer and management platform currently in use in 178 countries. This
partnership will combine expertise in (a) computational pathology of the Madabhushi group, (2) clinical,
pathological and biomarker expertise of PCa from the University of Pennsylvania (D...

## Key facts

- **NIH application ID:** 10697304
- **Project number:** 5R01CA268287-02
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** Shilpa Gupta
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $627,645
- **Award type:** 5
- **Project period:** 2022-09-05 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10697304

## Citation

> US National Institutes of Health, RePORTER application 10697304, Prognostic and Predictive Digital Tissue Image Assay for Prostate Cancer (5R01CA268287-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10697304. Licensed CC0.

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