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
  Purpose

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.


Condition Intervention
Prostate Cancer
Other: dietary education and counseling
Other: prostate cancer foundation booklet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • disease progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 464
Study Start Date: January 2011
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A - MEAL Program Intervention
Patients will receive dietary education and telephone counseling sessions over 24 months.
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.
Other: prostate cancer foundation booklet

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238172

  Show 180 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: J. Kellogg Parsons, MD, MHS University of California, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01238172     History of Changes
Other Study ID Numbers: CALGB-70807, CALGB-70807, CDR0000687958
Study First Received: November 9, 2010
Last Updated: August 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Disease Progression
Prostatic Neoplasms
Disease Attributes
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on August 27, 2015