This phase 3 trial aims to evaluate the benefit of a diet and exercise program in overweight men with low-risk prostate cancer. The main outcome to be investigated is a change in blood sugar metabolism in prostate cancer cells. The trial is recruiting in Seattle (Washington), USA.
The details
Low-risk prostate cancer is often managed with active surveillance. Active surveillance of prostate cancer refers to actively monitoring tumor growth without actually administering treatment. Previous studies have suggested that certain factors, such as obesity, can increase the risk of cancer progression. A lifestyle intervention during active surveillance that promotes weight loss may, therefore, improve prostate health.
This study will examine whether a diet and exercise program during active surveillance reduces the risk of disease progression compared to active surveillance alone. Biopsies (tissue samples) measuring a change in blood sugar metabolism in prostate cancer cells will give an indication of disease progression.
Who are they looking for?
This study will recruit about 200 men between the ages of 40 and 75 with localized (confined) low-risk or low-intermediate-risk prostate cancer. Participants must be undergoing active surveillance with planned annual prostate biopsies. Participants must be overweight or obese with a BMI (body mass index, a measure of body fat that takes weight and height into account) over 25. Participants must be able to undertake a diet and exercise program.
Patients cannot take part in the trial if they are currently undergoing a weight loss program or have done so within the past year. Participants should not have medication-dependent diabetes or history of heart or blood vessel disease. Current use of hormones will also prevent patients from taking part.
How will it work
Participants will be randomly assigned to either undergo active surveillance with a diet and exercise program or continue on active surveillance alone. The diet and exercise program will consist of a structured diet plan and 16 exercise sessions lasting 30 minutes to 1 hour over a 24-week period. Men undergoing active surveillance alone will undergo 20 to 30-minute informational sessions 5 days a week as well as a mild exercise routine.
A biopsy 6 months before the study and a second biopsy 6 months after the study will measure changes in blood sugar metabolism in prostate cancer cells. Blood tests will also measure blood sugar and energy metabolism for up to 12 months. Weight loss, maintenance of lifestyle changes, and quality of life will also be recorded for up to 12 months.
