A Phase II Randomized, Open-Label, Two-Arm Study of a Low-Fat Diet With Fish Oil Capsules vs. a Control Group in Men on Active Surveillance for Prostate Cancer


Condition: Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02176902

Sponsor: Jonsson Comprehensive Cancer Center

Eligibility:

  • Age: minimum 50 Years maximum 80 Years
  • Gender: Male

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

View trial on ClinicalTrials.gov


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