CALGB 70807: The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance

Study Status

Open to Enrollment

Study Description

This research study is for men with clinically localized, low risk prostate cancer who have already decided to be managed by active surveillance.

The purpose of this study is to find out how diet may prevent prostate cancer from getting worse. Eating a diet high in vegetables may slow down disease progression in men with prostate cancer. The study will determine if a telephone-based dietary intervention, compared to no intervention, will decrease disease progression.

In the first 2 weeks after you join the study, researchers will call you on the telephone on 3 different days to ask questions about your medical history and diet. During these interviews, you will be asked to recall everything you ate and drank during the previous 24 hours. These phone interviews will take about 20 minutes.

After completing the 3 initial telephone interviews, study participants will be randomly assigned to one of two study groups:

  • Group 1: A program providing you with telephone counseling to help change your diet. You will be asked to change your diet to increase the amount of fiber-rich vegetables, fruit, whole grains and beans that you eat. These counseling calls will take an average of 30 minutes and will occur twice weekly for the first 2 weeks, then gradually decrease in frequency (weekly, bi-monthly, monthly). After the first 6 months, your counselor will call you periodically throughout the remainder of the study to check on how you are maintaining the study diet. Participants will receive a total of 22 calls over a 24-month period.
  • Group 2: A program providing you with information about your diet and cancer. You will receive an initial telephone orientation call that takes about 5 to 10 minutes, as well as a booklet containing information about nutrition, exercise and prostate cancer. Regularly scheduled newsletters will also be provided to you.

Study participants in both groups will complete the following tests and procedures:

  • A complete history and physical exam every 3 months
  •  A PSA test every 3 months
  • A digital rectal exam every 12 months
  • A prostate biopsy every 12 months

Participants will be in the study for 2 years.

Sponsor

CALGB

Key Eligibility

  • Men age 50 to 80
  • Diagnosed with prostate cancer within the past 2 years
  • No prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e., cryosurgery, or high-intensity focused ultrasound), or androgen-deprivation therapy
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Scott Tagawa, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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