MEAL Study Eligibility
To participate in the MEAL Study, men must meet a certain set of criteria. Please review the following to determine if you are eligible to take part in the clinical trial:
- Must be between the ages of 50 and 80
- Must be in relatively good health with a life expectancy of at least three years
- Must have received a diagnosis of prostate cancer via biopsy within the previous two years
- Must be able to understand written and spoken English
- Must not be undergoing active treatment (e.g., surgery, irradiation, cryosurgery, high-intensity focused ultrasound or androgen deprivation therapy)
- Must not be taking Coumadin or 5-alpha reductase inhibitors, such as finasteride or dutasteride
- Must have a clinical cancer stage of 2A or less in no more than 25% of the cores in the biopsy responsible for the cancer diagnosis; must also have cancer in no more than 50% of any one of these cores
- Must have no other cancer diagnoses (with the exception of non-melanoma skin cancer) within the previous five years
- If younger than age 70, the Gleason grade of the prostate cancer must be 6 or less. If age 70 or older, the Gleason grade of prostate cancer must be 7 (3+4) or lower. The baseline prostate-specific antigen (PSA) must be 10 or lower.
- Men who are already consuming more than six servings of fruits and vegetables per day are not eligible to join.
If determined eligible, the participant must also agree to meet the following requirements:
- Undergo a brief physical examination
- Fill out three 24-hour diet recalls prior to randomization
- Have PSA levels checked every three months
- Complete a brief questionnaire every six months to assess quality of life
- Undergo a digital rectal exam at 12 and 24 months, per his urologist's judgment
- Must receive a prostate biopsy at 12 and 24 months
- Provide a blood sample at the beginning of the study, and again after 12 and 24 months
- If assigned to the diet change group, participants will take part in 20 phone counseling sessions with the diet change center. Participants must attempt to change their diet as recommended by the diet change counselors.