Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Symptoms and General Pathology

Prostatic Neoplasms

Adenocarcinoma

Disease Progression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Disease Attributes

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

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

dietary education and counseling

prostate cancer foundation booklet

J. Kellogg Parsons, MD, MHS

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.

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.

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

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

Time to progression (TTP) was defined as the length of time from the date of random assignment to progression; patients who died from any cause without experiencing disease progression were censored at the time of death. Disease progression is defined by (a) PSA doubling time (PSADT) less than 3 years, (b) PSA above 10 at any time, or (c) Gleason score on repeat biopsy ≥ 7 for men 70 years or younger and ≥ 4+3 = 7 for men older than 70 years. For the primary analysis, TTP was analyzed using the Kaplan-Meier method; the log-rank test was used to determine superiority of the intervention arm (Arm A: MEAL Program Intervention) compared with the control arm (Arm B: Prostate Cancer Foundation Booklet).

Time to treatment was analyzed by the Kaplan-Meier method. For this analysis, patients who did not withdrawal from the study to pursue treatment were censored at the time of clinical progression, death, or their last follow-up visit, whichever occurred first. The number of patients who observed an event (treatment) are summarized below.

Quality of Life (QOL) was measured using Observed Total Summary Score of Memorial Anxiety Scale for Prostate Cancer \[MAX-PC\] at Month 24 on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. MAX-PC is a prostate cancer-specific measure to assess patient anxiety due to prostate cancer, PSA tests and fears of recurrence. Change from baseline to month-24 was calculated by subtracting the baseline scores from the scores at month-24. Higher scores on MAX-PC indicate better QOL

At baseline and 24 months, participant diet including total vegetables (servings/day) was measured with a series of three separate interviews at each time point, on three-randomly selected days in a single week, using the Nutrition Data Systems for Research (NDS-R, current version 2010, University of Minnesota Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and nutrient database. Total vegetables were measured as the number of servings per day (range: ≥ 0), where higher values correspond to more servings per day. The within-participant change from baseline at 24 months was calculated by subtracting the baseline number of servings per day from the number of servings per day at month 24; positive values correspond to increased consumption of total vegetables.

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Adverse events were not collected for this study.

Arm A - MEAL Program Intervention

Patients receive education material about diet, nutrition, exercise and cancer.

Arm B - Prostate Cancer Foundation Booklet

Total

Age, Continuous

Sex: Female, Male

American Indian or Alaska Native

Asian

Black or African American

Hispanic or Latino

More than one race

Native Hawaiian or Pacific Islander

White

Not Reported

Race/Ethnicity, Customized

United States

Region of Enrollment

Body Mass Index (BMI)

The m-ITT population included all randomized patients; however, patients who later became ineligible by eligibility review or centralized pathology review of their baseline tissue specimens were excluded.

J. Kellogg Parsons, M.D., MHS

The primary analysis was based on the modified intention-to-treat (m-ITT) analysis population. The m-ITT population included all randomized patients; however, patients who later became ineligible by eligibility review or centralized pathology review of their baseline tissue specimens were excluded.

Time to Progression

Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed

modified ITT population: Only participants with available data on the individual study measure at baseline and 24 months were included in the analysis.

Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24

Participants with available data on the individual study measure at baseline and 24 months were included in the analysis

Spots Global Cancer Trial Database for prostate cancer foundation booklet