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

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ClinicalTrials.gov Identifier: NCT01238172
Recruitment Status : Completed
First Posted : November 10, 2010
Results First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE November 9, 2010
First Posted Date  ICMJE November 10, 2010
Results First Submitted Date  ICMJE February 20, 2019
Results First Posted Date  ICMJE March 12, 2019
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE January 2011
Actual Primary Completion Date November 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
Time to Progression [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2010)
Progression defined by PSA doubling time (PSADT) < 3 years, PSA > 10 at any time, or Gleason sum on repeat biopsy ≥ 7 (for men < 70 years) or ≥ 4+3 = 7 (for men ≥ 70 year)
Change History Complete list of historical versions of study NCT01238172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
  • Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2010)
  • Progression defined by PSADT and time to progression
  • time to treatment
  • Comparison of quality of life (anxiety and depression, prostate cancer symptom checklist) between the two arms
  • Diet as evaluated by three separate 24-hour dietary recalls at baseline and at 12 and 24 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance
Official Title  ICMJE The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Other: dietary education and counseling
  • Other: prostate cancer foundation booklet
Study Arms  ICMJE
  • Experimental: Arm A - MEAL Program Intervention
    Patients will receive dietary education and telephone counseling sessions over 24 months.
    Intervention: Other: dietary education and counseling
  • Experimental: Arm B - Prostate Cancer Foundation Booklet
    Patients receive information about diet, nutrition, exercise and cancer. Patients also receive regularly scheduled newsletters.
    Intervention: Other: prostate cancer foundation booklet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2019)
478
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2010)
464
Actual Study Completion Date  ICMJE January 15, 2019
Actual Primary Completion Date November 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01238172
Other Study ID Numbers  ICMJE CALGB-70807
CALGB-70807
CDR0000687958 ( Registry Identifier: NCI Physician Data Query )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: J. Kellogg Parsons, MD, MHS University of California, San Diego
PRS Account Alliance for Clinical Trials in Oncology
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP