This trial studies how well weight management works in reducing risk and improving outcomes in participants undergoing radical prostatectomy. Men who are overweight at the time of prostate cancer surgery are more likely to have their cancer come back than healthy weight men because fat tissue makes signals that allow cancer to grow and extend beyond the prostate gland. Weight management before removal of prostate cancer may help help weaken the cancer before surgery, prevent it from spreading, and improve survival and quality of life.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03261271.
PRIMARY OBJECTIVES:
I. To test the impact of weight management on obesity-driven prostate cancer (PCa) biomarkers taken at baseline, 1 week prior to surgery, surgery and 6 months after surgery.
II. To evaluate how weight management affects weight loss, body composition, and weight maintenance in overweight and obese men with localized PCa.
III. To test the impact of weight management on quality of life (QoL) in PCa survivors.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I: Participants receive the book, “Dr. Walsh’s Guide to Surviving Prostate Cancer”and the American Institute for Cancer Research booklet, “Heal Well, A Cancer Nutrition Guide" and participate in a weight loss program for at least 4 weeks (and up to 16 weeks) before surgery and a weight maintenance program for 26 weeks after surgery. Participants receive one-on-one behavior therapy/coaching sessions over 60 minutes weekly before surgery and 4 group coaching sessions every 6 weeks after surgery. Participants use the Medifast 5 & 2 & 2 meal plan, prepare their own meals, and track their food via an online application. Participants also exercise over 150 minutes per week and track steps using an accelerometer. Participants also undergo 2 unannounced 24-hour dietary recalls on non-consecutive days (one weekday and one weekend day).
GROUP II: Participants receive the educational book and booklet and undergo dietary recall as in Group I.
After completion of study, participants are followed up annually for up to 5 years.
Trial PhaseNo phase specified
Trial Typebasic science
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorJill M. Hamilton-Reeves
