Prostate Cancer Active Lifestyle Study (PALS)
Looking for men with prostate cancer on active surveillance
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The PALS Study is a study for prostate cancer patients who have chosen Active Surveillance of their cancer. The goal is to learn whether weight loss, through diet and exercise, will improve the health of men with low-grade prostate cancer.
PALS will enroll about 200 overweight or obese men who plan to have a follow-up biopsy for prostate cancer. Men will be followed for 1 year. The 1-year start and end dates overlap with the prostate biopsy that is scheduled as routine care for Active Surveillance.
Study activities will take place at the Fred Hutch Cancer Research Center in Seattle. At the first visit, men will be randomly assigned to either the ‘PALS Lifestyle’ group or the ‘Comparison’ group.
Men are eligbile to participate who have:
- Localized, low to intermediate risk prostate cancer
- Prostate Specific Antigen (PSA) <20 ng/mL
- Chose Active Surveillance with planned biopsies as primary treatment for prostate cancer
- Body mass index (BMI) of 25 kg/m2 or more
Men are not be eligible for this study who:
- Recently joined (<1 year) or plan to join a weight loss program
- Currently take or plan to take appetite suppressants
Or have the following conditions:
- Significant cardiovascular disease.
- Insulin dependent diabetes mellitus (DM)
- Cognitive impairment
- Current alcohol or narcotic abuse
Or use the following medications:
- Steroid hormones (antiandrogen therapy)
Participants in both study groups will complete the following activities:
- Physical measurements – weight, height, and waist and hip measures will be collected 4 times during the study.
- Body Scan - a body scan will measure total body fat, lean mass and total bone density 2 times during the study.
- Exercise test—a treadmill test will be completed 2 times during the study.
- Surveys—a food diary, activity, health, and quality of life surveys will be completed up to 4 times during the study.
- Give blood – blood will be collected 4 times during the study.
- Donate biopsy tissue that is collected as part of routine clinical care for Active Surveillance.
Men in the ‘PALS Lifestyle’ group will also:
- Meet with a nutritionist up to 11 times during the first 6 months of the study. The nutritionist will teach men ways to reduce calories and fat and increase exercise.
- Complete exercise sessions with an exercise specialist.
- Wear a heart rate monitor on occasion.
Men in the ‘Comparison’ group will also:
- Meet with a nutritionist once to learn about standard guidelines for a healthy diet, physical activity and weight loss.
All men will receive $100 to finish the study. After the study ends, all men will receive the results of their exercise and body scan tests.
Dr. Jonathan Wright discusses PALS and the role of the participant.