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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 12-000517
    • Rochester, Minnesota: 12-000517
    NCT ID: NCT01238172
    Sponsor Protocol Number: CALGB 70807

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

DISEASE CHARACTERISTICS:

  • Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to presentation
    • < 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
  • For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason score ≤ (3 + 4) = 7
  • Serum PSA < 10 ng/mL
    • Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors
  • Patients are offered registration to the correlative study CALGB-151105

PATIENT CHARACTERISTICS:

  • Life expectancy of at least 3 years
  • Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone
  • Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible
  • Successful completion of three 24-hour dietary recalls during the run-in period

PRIOR CONCURRENT THERAPY:

  • 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
  • Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible
  • Patients who are currently taking coumadin are not eligible
  • Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as measured by the run-in dietary recalls, are not eligible
  • Patients receiving treatment with 5-alpha reductase inhibitors within 90 days prior to preregistration are not eligible

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

R. Jeffrey Karnes, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

R. Jeffrey Karnes, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20115508

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