# Randomized Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer:

> **NIH NIH R01** · SLOAN-KETTERING INST CAN RESEARCH · 2022 · $715,452

## Abstract

Abstract
Widespread use of serum prostate-specific antigen (PSA) screening results in 50% of new cases of prostate
cancer being diagnosed with low-grade localized disease. Standard of care for these cases is to defer immediate
treatment in favor of active surveillance (AS), a low-toxicity management which entails close monitoring with
PSA tests, repeat prostate biopsies and multi-parametric MRI (mpMRI). Around 30% of men on AS progress or
electively undergo definitive treatment within two years of diagnosis. Efficacious low-cost, low-toxicity strategies
to limit exit from AS are needed to reduce over-treatment and improve health-related quality of life (QOL).
 Accordingly, in this proposal we will test whether and how exercise alters prostate cancer molecular
landscape. Using a two-arm RCT design, 122 men initiating AS (e.g., inactive, diagnostic biopsy <6 months) will
be randomly allocated (1:1 ratio) to exercise therapy intervention (n=61) or usual care (plus general physical
activity advice; n=61) for 12 months. Exercise therapy will consist of home-based, treadmill walking five days
each week at 65-75% of their personal baseline exercise capacity. All sessions will be implemented using
TeleMed-X, a novel telemedicine platform pioneered in our program. Our central hypothesis is that exercise
therapy will reduce the number of nimbosus features to collectively inhibit clinical progression. This central
hypothesis is tested in three distinct, but complementary aims: Aim 1. Determine effects of exercise therapy on
molecular nimbosus hallmarks; Aim 2. Determine effects on the radiologic and pathologic nimbosus hallmarks;
and Aim 3. Delineate the precision of estimating rates of clinical progression at 18 months.

## Key facts

- **NIH application ID:** 10498187
- **Project number:** 1R01CA272678-01
- **Recipient organization:** SLOAN-KETTERING INST CAN RESEARCH
- **Principal Investigator:** Paul Christopher Boutros
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $715,452
- **Award type:** 1
- **Project period:** 2022-09-15 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10498187

## Citation

> US National Institutes of Health, RePORTER application 10498187, Randomized Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer: (1R01CA272678-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10498187. Licensed CC0.

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