Diet in Altering Disease Progression in Patients with Prostate Cancer on Active Surveillance
This randomized phase III trial studies how well diet works in altering disease progression in patients with prostate cancer on active surveillance. Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.
Inclusion Criteria
- 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 NOTE: if a patient undergoes a transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH), and prostate cancer is diagnosed incidentally from the TURP specimen, eligibility for CALGB 70807 cannot be determined from the TURP specimen; however, if the patient subsequently undergoes a minimum 10-core prostate biopsy within 2 years of prostate cancer diagnosis from the TURP, and prostate cancer is detected in the biopsy specimen and meets the requirements above, the patient is eligible for this study; if prostate cancer is not detected in the biopsy specimen, the patient is not eligible
- 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
- 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
- For men =< 70 years, biopsy Gleason score =< 6; for men > 70 years, biopsy Gleason score =< (3 + 4) = 7
- Serum prostate specific antigen (PSA) < 10 ng/mL * NOTE: baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors
- REGISTRATION ELIGIBILITY
- 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
Additional locations may be listed on ClinicalTrials.gov for NCT01238172.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
l. To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in active surveillance (AS) patients.
SECONDARY OBJECTIVES:
I. To compare the incidence of active treatment (surgery, irradiation, local ablation, or androgen deprivation) in AS patients receiving dietary intervention compared to no intervention.
II. To compare prostate cancer-related anxiety in AS patients receiving dietary intervention compared to no intervention.
III. To compare health-related quality of life in AS patients receiving dietary intervention compared to no intervention.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive the men's eating and living (MEAL) program intervention with dietary education and telephone counseling sessions for 24 months. Patients receive a copy of the Prostate Cancer Foundation Booklet entitled “Nutrition, Exercise and Prostate Cancer” and a copy of the study-specific “Lifestyle Intervention Manual” which will be referred to during every counseling call. It also outlines the dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and offers recipes and articles about diet and prostate cancer. The counseling sessions are divided into 4 phases, with the first three phases completed in 7 months and the fourth phase continuing for 17 months. The first phase comprises 6 counseling calls focusing on education and the rapid development of self-efficacy, the second phase comprises 4 calls over a 2-month period focusing on practical and consistent implementation of the dietary pattern, the third phase comprises 4 calls over a 4-month period helping patients habituate to the dietary pattern by providing regular performance reviews, and the fourth phase comprises 8 calls over a 17-month period and is a maintenance phase. Patients are encouraged to achieve 7 servings per day of vegetables (2 cruciferous, 2 tomato products, 3 other vegetables), 2 servings per day of whole grains, 1 serving per day of beans or other legumes, and 2 servings per day of fruit. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters focus on study goals and progress and provide tips on achieving and maintaining diet change. They also include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes.
ARM II: Patients receive a copy of the Prostate Cancer Foundation Booklet entitled “Nutrition, Exercise and Prostate Cancer”. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters contain general information about diet and healthy lifestyle.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationAlliance for Clinical Trials in Oncology
Principal InvestigatorJohn Kellogg Parsons
- Primary IDCALGB 70807
- Secondary IDsNCI-2011-02613, CALGB-70807, CDR0000687958
- ClinicalTrials.gov IDNCT01238172