This study is in progress, not accepting new patients

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

a study on Prostate Cancer

Summary

Eligibility
for males ages 50-80 (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around

Description

Summary

This randomized phase II trial will evaluate if a low omega-6, high omega-3 fat diet combined with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.

Official Title

A Phase II Randomized, Open-Label, Two-Arm Study of a Low Omega-6, High Omega-3 Fat Diet Combined with Fish Oil Vs. a Control Group in Men on Active Surveillance for Prostate Cancer

Details

PRIMARY OBJECTIVES:

  1. Determine if a 1-year low omega-6, high omega-3 fat diet combined with fish oil results in decreased prostate cancer Ki-67 index as compared to a control group in men on active surveillance.

SECONDARY OBJECTIVES:

  1. Evaluate the effect of a low-fat (LF)/fish oil (FO) intervention on prostate biopsy tissue markers of progression, prostate biopsy pathologic features (Gleason grade, tumor volume ), prostate-specific antigen (PSA), and long-term clinical outcomes (clinical progression, prostate cancer therapies).

II. Evaluate potential surrogate biomarkers of proliferation (red blood cell [RBC] membrane fatty acid analyses, ex-vivo bioassay).

III. Determine if a correlation exists between free fatty acid receptor 4 (GPR120) levels and progression markers in response to the LF/FO intervention.

IV. Evaluate effect of the intervention on the National Comprehension Cancer Network (NCCN) risk group V. Evaluate compliance with a 1-year + 2 year extension LF/FO intervention. VI. Evaluate safety of a 1-year + 2-year extension LF/FO intervention.

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive no intervention.

ARM II: Patients receive dietary counseling with a research dietitian weekly for 1 month and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a high omega-3, low omega-6 diet comprising 30% kilocalories (Kcal) from fat, 15% Kcal from protein, and 65% Kcal from carbohydrates for 1 year. Patients also receive 4 fish oil capsules per day orally (PO) for 1 year.

After completion of study, patients are followed up yearly for 15 years.

Keywords

Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Prostatic Neoplasms, behavioral dietary intervention, omega-3 fatty acid, laboratory biomarker analysis, fish oil

Eligibility

You can join if…

Open to males ages 50-80

  • 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 < 25
  • 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

You CAN'T join if...

  • 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

Location

  • Jonsson Comprehensive Cancer Center
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT02176902
Study Type
Interventional
Participants
About 107 people participating
Last Updated