Summary

Eligibility
for males ages 50-80 (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by William Aronson (ucla)

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVES: I. Determine if a 1-year low-fat fish oil (omega-3 fatty acid) supplemented diet results in decreased prostate cancer Decipher score as compared to a control group in men on active surveillance. SECONDARY OBJECTIVES: I. 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 20% 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

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 < 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

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 accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Cancer

  • William Aronson (ucla)
    Professor-in-Residence, Urology. Authored (or co-authored) 200 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT02176902
Study Type
Interventional
Last Updated