Los Angeles, California 90095

  • Stage IIB Prostate Cancer

Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02176902


Primary Contact:

Principal Investigator
William Aronson
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States

William Aronson
Phone: 310-268-3446
Email: waronson@ucla.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 26, 2021

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