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

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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.