Trial record 1 of 1 for:    CALGB 70807
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Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01238172
First received: November 9, 2010
Last updated: August 20, 2015
Last verified: August 2015

November 9, 2010
August 20, 2015
January 2011
June 2017   (final data collection date for primary outcome measure)
disease progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
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) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01238172 on ClinicalTrials.gov Archive Site
  • time to progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • time to treatment [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • dietary recall evaluated at baseline, month 12 and month 24 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Progression defined by PSADT and time to progression [ Designated as safety issue: No ]
  • Time to treatment [ Designated as safety issue: No ]
  • Comparison of quality of life (anxiety and depression, prostate cancer symptom checklist) between the two arms [ Designated as safety issue: No ]
  • Diet as evaluated by three separate 24-hour dietary recalls at baseline and at 12 and 24 months [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Other: dietary education and counseling
  • Other: prostate cancer foundation booklet
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
464
Not Provided
June 2017   (final data collection date for primary outcome measure)

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.
Male
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01238172
CALGB-70807, CALGB-70807, CDR0000687958
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: J. Kellogg Parsons, MD, MHS University of California, San Diego
Alliance for Clinical Trials in Oncology
August 2015

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