# Phase 2 randomized Total Eradication of metastatic lesions following definitive Radiation to the Prostate in de novo oligometaStatic prostate cancer (TERPS) trial

> **NIH NIH U54** · UNIVERSITY OF MARYLAND BALTIMORE · 2022 · $367,352

## Abstract

The metastatic capacity of prostate cancer (PCa) behaves along a spectrum of disease that contains an
oligometastatic state where metastases are limited in number and location. The importance of radiation
consolidation of all tumor deposits in oligometastatic PCa to forestall further metastatic dissemination is now
backed by small randomized studies in the recurrent setting, but the utility in the de novo space is unknown. Our
Baltimore ORIOLE randomized trial of stereotactic ablative radiation (SABR) alone, highly focused, high-dose
radiation, versus observation in oligometastatic PCa demonstrated a progression-free survival (PFS) benefit of
SABR alone. Furthermore, using state-of-the-art genomic profiling techniques we demonstrated that radiation
resulted in a systemic immune response that could possibly predict patient benefit from SABR. Total
consolidative radiation approaches have not been tested in the de novo oligometastatic space for PCa. Thus,
we propose this first-in-man opportunity to understand the interplay between micrometastatic disease and the
primary PCa following radiation consolidation of macroscopic disease has the potential to: (1) uncover novel
radiobiology implications on the metastatic process; and (2) provide a curative paradigm for patients with de
novo oligometastatic PCa. For this proposal, we will leverage resources from a soon to be activated randomized
trial of total radiation consolidation for de novo oligometastatic men – Phase 2 randomized Total Eradication of
metastatic lesions following definitive Radiation to the Prostate in de novo oligometaStatic prostate cancer
(TERPS) trial. TERPS is a phase II non-blinded, randomized 1:1 trial of men with de novo oligometastatic PCa
treated with best systemic therapy (BST) + primary prostate radiation (XRT) versus BST+XRT+ stereotactic
ablative radiation metastasis-directed therapy (SABR MDT). Now, strategies to define the patients who may
benefit the most from SABR metastasis-directed therapy (MDT) are needed using biomarkers. This current U54
ROBIN Oligometastasis (ROBIN OligoMET) Molecular Characterization Trial (MCT) proposal is to conduct
correlative studies from this first-in-man randomized trial of SABR MDT in men with de novo oligometastatic
prostate cancer. We hypothesize macroscopic prostate tumors support the growth of and help nurture future
distant metastases. In addition, we hypothesize that tissue, imaging and circulating biomarkers can identify men
with de novo PCa oligometastasis that benefit the most from SABR. AIM #1 – To validate prognostic-predictive
ability of tissue and liquid biomarkers using the first-in-man randomized trial of stereotactic ablative radiation
(SABR) consolidation in men with de novo oligometastatic castration-sensitive prostate cancer.
AIM #2 – To
validate prognostic-predictive ability of radiomics using the first-in-man randomized trial of stereotactic ablative
radiation (SABR) consolidation in men with de novo oligometastatic ca...

## Key facts

- **NIH application ID:** 10515451
- **Project number:** 1U54CA273956-01
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Phuoc T. Tran
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $367,352
- **Award type:** 1
- **Project period:** 2022-08-04 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10515451

## Citation

> US National Institutes of Health, RePORTER application 10515451, Phase 2 randomized Total Eradication of metastatic lesions following definitive Radiation to the Prostate in de novo oligometaStatic prostate cancer (TERPS) trial (1U54CA273956-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10515451. Licensed CC0.

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