Trial Information

Exploring the Impact of Negative Energy Balance in Men With Prostate Cancer

This is a 2-arm randomized controlled feasibility trial among 40 overweight or obese men
newly diagnosed with prostate cancer who are scheduled for prostatectomy. This study will
use the presurgical period to explore the potential impact of weight loss via a healthy
energy-restricted diet and increased physical activity on circulating hormones, cytokines,
and growth factors, as well as effects on tumor biology and other clinical outcomes.
Consenting patients will be block randomized to 1-of-2 study arms: 1) a healthful diet +
exercise intervention to promote a weight loss of up to 2 pounds/week; or 2) a wait-list
control who will receive the intervention once the study period is complete. Both groups
will receive nutritional counseling during the study period to correct nutritional
deficiencies with food sources. This study will explore and contrast changes in body mass
index (BMI) observed over the study period (minimum of 3.5 weeks) in the intervention vs.
wait-list control arms, and also monitor changes in body composition, energy intake and
physical activity; these changes will be studied in relation to the following endpoints: a)
changes in select circulating biomarkers and gene expression related to cancer progression,
hormonal status, inflammation and other energy-related factors; b) rates of tumor
proliferation and apoptosis; c) tumor immunohistochemical markers of insulin receptor,
vascular endothelial growth factor (VEGF), AKT, and nuclear factor
kappa-light-chain-enhancer of activated B cells (NFkB); and d) functional and health-related
outcomes, i.e., side-effects and medical outcomes, quality of life (QoL), and functional
status.