Clinical Trial Details

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Study ID CDR0000687958
Investigator
J. Kellogg Parsons, MD, MHS,   University of California, San Diego
James Marshall, PhD,   Roswell Park Cancer Institute
Title Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance
Conditions Prostate Cancer
Interventions Behavioral: telephone-based intervention
Other: counseling intervention
Other: educational intervention
Procedure: therapeutic dietary intervention
Phase N/A
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.
Eligibility Ages Eligible: 50 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
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
  • Study Location
    Adult and Pediatric Urology, PLLP
    Sartell, Minnesota, 56377
    Contact Donald J. Jurgens
    320-259-1411
    Information objtained from ClinicalTrials.gov, on 10/23/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT01238172


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