Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Other: prostate cancer foundation booklet; Other: dietary education and counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01238172

CDR0000687958 (Registry Identifier)

CALGB-70807

Details and patient eligibility

About

RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.

PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.

Full description

CALGB 70807 is a randomized, phase III clinical trial designed to test this practical, diet-based intervention for prostate cancer in a broader clinical setting. Patients on AS will be randomized either to an intervention of centralized, telephone-based dietary counseling and structured dietary education or to a comparison control condition in which they receive the Prostate Cancer Foundation booklet. Study endpoints will include disease progression, incidence of treatment, and health-related quality of life.

OBJECTIVES:

Primary

• To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in AS patients.

Secondary

• 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.

OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 70 years vs > 70 years), race (black or african american vs other), and baseline prostate biopsy (0-12 months before registration vs > 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more information.

Enrollment: 478 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Preregistration Eligibility:

1. 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.

   • Eligible patients must meet all of the following 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.

2. 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.

3. Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible.

4. Language: Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone.

5. Life expectancy of at least 3 years

6. Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible.

7. 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.

8. Patients who are currently taking coumadin are not eligible.

9. Participants will be men aged 50 to 80 years.

10. For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason score ≤ (3 + 4) = 7.

11. 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.

Registration Eligibility:

1. Successful completion of three 24-hour dietary recalls during the run-in period.
2. Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as determined by the run-in dietary recalls are not eligible.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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478 participants in 2 patient groups

Arm A - MEAL Program Intervention

Experimental group

Description:

Patients will receive dietary education and telephone counseling sessions over 24 months.

Treatment:

Other: dietary education and counseling

Arm B - Prostate Cancer Foundation Booklet

Experimental group

Description:

Patients receive information about diet, nutrition, exercise and cancer. Patients also receive regularly scheduled newsletters.

Treatment:

Other: prostate cancer foundation booklet