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

Prostate Cancer Clinical Trial

Official 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Disease Progression
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01238172
• Study type: Interventional
• Source: Alliance for Clinical Trials in Oncology
• Status: Completed
• Phase: Phase 3
• Start date: January 2011
• Completion date: January 15, 2019