Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance
- Conditions
- Prostate Cancer
- Registration Number
- NCT01238172
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 478
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to Progression Up to 2 years 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).
- Secondary Outcome Measures
Name Time Method Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed Up to 2 years 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 Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24 Up to 2 years 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
Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall Up to 2 years 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.
Trial Locations
- Locations (180)
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
🇺🇸Fairbanks, Alaska, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Kaiser Permanente Medical Center - Bellflower
🇺🇸Bellflower, California, United States
California Cancer Care, Incorporated - Greenbrae
🇺🇸Greenbrae, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Kaiser Permanente Medical Center - Los Angeles
🇺🇸Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Saint Helena Hospital
🇺🇸Saint Helena, California, United States
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
🇺🇸San Diego, California, United States
Scroll for more (170 remaining)Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital🇺🇸Fairbanks, Alaska, United States