Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title The men’s eating and living (meal) study: a randomized trial of diet to alter disease progression in prostate cancer patients on active surveillance
IRB CALGB70807
CC FLA11-071
Hospital Florida Weston
Stage Stage 1, Stage 1A, Stage 1B, Stage 1C, Stage 2, Stage 2A
Disease Prostate
Drug Dexamethasone
Description
Primary Objective
- To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in AS patients.
Secondary Objectives
- To compare the incidence of active treatment (surgery, irradiation, local ablation, or androgen deprivation) in AS patients receiving dietary intervention compared to no intervention.
- To compare prostate cancer-related anxiety in AS patients receiving dietary intervention compared to no intervention.
- To compare health-related quality of life in AS patients receiving dietary intervention compared to no intervention.
Inclusion Criteria
- Histologic Documentation: The initial biopsy showing diagnosis of prostate cancer should be used for the purposes of determining eligibility. However, if a subsequent biopsy performed before patient enrollment shows that the patient is ineligible, he may not be enrolled to the study.
- Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to pre-registration.
- < 25% of biopsy tissue cores positive for cancer.
- ≤ 50% of any one biopsy tissue core positive for cancer.
- Clinical stage ≤ T2a.
- Patients who have prostate cancer with distant metastases are not eligible.
- Prior Treatment: Patients who have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e. cryosurgery or high-intensity focused ultrasound) or androgen deprivation therapy are not eligible.
- Patients who have had a history of non-cutaneous malignancy (other than non-melanoma skin cancer) in the previous 5 years are not eligible.
- Language: Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone.
- Life expectancy of at least 3 years.
- Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible.
- Patients receiving treatment with 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) within 90 days prior to preregistration are not eligible. Treatment with these agents during the protocol intervention is not permitted.
- Patients who are currently taking coumadin are not eligible.
- Participants will be men aged 50 to 80 years.
- For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason score ≤ (3 + 4) = 7.
- Required Initial Laboratory Values:
- Serum PSA < 10 ng/mL. NOTE: Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors.
- Successful completion of three 24-hour dietary recalls during the run-in period.
- Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as determined by the run-in dietary recalls are not eligible.
