# Quantifying and Personalizing the Clinical Benefit of Metastasis-Directed Therapy in Men with De Novo Oligometastatic Prostate Cancer

> **NIH NIH U01** · CASE WESTERN RESERVE UNIVERSITY · 2024 · $445,266

## Abstract

Project Summary/Abstract
The long-term goal of this project is to determine the clinical impact of metastasis-directed radiotherapy (MDT)
in men with de novo oligometastatic prostate cancer (PCa), and identify which men may be cured and benefit
most from MDT. We aim to achieve this goal through the conduct of a phase 3 randomized controlled trial with
prospective imaging and biospecimen (e.g. tissue and blood) collection. This trial is novel in that it is a
randomized North American sub-study (n=200) of the next arm (Arm M) of the international landmark multi-
arm, multi-stage, STAMPEDE trial. The ability to conduct this trial with comprehensive biospecimen collection
and imaging analysis will be achieved through our unique research team across extramural and intramural
centers, comprised of experts in prognostic and predictive biomarker signature identification, bioinformatics,
biostatistics, genomics, imaging, and clinical trial execution. We will leverage the opportunity for North America
to participate in the STAMPEDE trial to not simply identify the true impact of MDT in the first ever large phase 3
trial testing MDT in PCa, but use this one of a kind clinical trial working with the NCI to develop the first
predictive biomarkers of benefit of MDT using radiomics of conventional and molecular PET imaging, as well
as sequencing of primary, metastatic, and liquid biopsies. This goal will be carried out through three specific
aims. Aim 1 will focus on the conduct of the phase 3 randomized North American sub-study to determine if the
addition of MDT to standard systemic therapy and treatment of the primary improves failure-free survival. Five
centers will participate, including the NIH Clinical Center. These patients will all be included in the international
STAMPEDE trial with the primary endpoint of overall survival. Aim 2 will leverage the baseline CT and bone
scans collected on all patients, as well as a subset that will be sent to the NCI to have pre-treatment 18F-
DCFPyL PET/CT scans performed (n=50). Radiomic analyses and image feature extraction will be performed,
and this information will be used to identify which men benefit most from MDT. We hypothesize that a subset
of men will benefit most from MDT and be identifiable through an imaging biomarker. Aim 3 will utilize the
baseline prostate biopsy, metastatic biopsies, radical prostatectomy specimens, and liquid biopsies (circulating
tumor cells and cell-free DNA), to annotate the molecular landscape of oligometastatic PCa. This data will
then be used to develop a predictive biomarker to identify which men benefit most from MDT. International
patient samples will be banked for later validation. We hypothesize that a discrete molecular profile will
characterize which men are most likely to be cured from MDT. The impact of this work is extremely large, as it
has the potential to cure a currently incurable subset of men with metastatic PCa. Successful completion of
these aims would result ...

## Key facts

- **NIH application ID:** 10488573
- **Project number:** 5U01CA257638-02
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Daniel Eidelberg Spratt
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $445,266
- **Award type:** 5
- **Project period:** 2021-09-14 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10488573

## Citation

> US National Institutes of Health, RePORTER application 10488573, Quantifying and Personalizing the Clinical Benefit of Metastasis-Directed Therapy in Men with De Novo Oligometastatic Prostate Cancer (5U01CA257638-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10488573. Licensed CC0.

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