Open Actively Recruiting

Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer

About

Brief Summary

This randomized phase II trial will evaluate if a low-fat diet with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.

Primary Purpose
Prevention
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
50 Years
Maximum Age
80 Years

Inclusion Criteria:

  • Patients sign the informed consent
  • Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate
  • Patient elects to undergo active surveillance
  • Clinical stage T2c or less
  • Gleason grade 3+4 or less
  • PSA < 20
  • Geographically able to have study visits at the University of California, Los Angeles (UCLA) Clinical Research Unit
  • Subjects are willing to not consume lycopene, green tea or pomegranate supplements or pomegranate juice during the 1-year study
  • If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study

Exclusion Criteria:

  • Diagnostic prostate biopsy with only 1 core with cancer and < 5% of tissue from that core involved with cancer
  • Patient has taken finasteride or dutasteride during the prior year
  • Patient has taken fish oil during the prior 3 months
  • Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)
  • Patient has other medical conditions that exclude him from undergoing a repeat prostate biopsy at 1-year
  • Patient has allergy to fish

Join this Trial

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Study Stats
Protocol No.
13-000432
Category
Oncology
Urology
Principal Investigator
William Aronson
Contact
Mikayla Lerman
Location
  • UCLA Westwood
For Providers
NCT No.
NCT02176902
For detailed technical eligibility, visit ClinicalTrials.gov.