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

NCT02176902 | Active Not Recruiting DMC

• 3 other identifiers: 13-000432NCI-2014-01257P50CA092131
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Ki-67 index

  The primary statistical analysis will be to compare the Ki67 index between the two intervention arms using a negative binomial mixed effects model

  1 year

Secondary Outcomes (8)

• Composite measure: Prostate biopsy tissue markers of proliferation, cell cycle progression, and prostate biopsy pathologic features (Gleason grade, percent of cores with cancer, and percent of tissue with cancer)

  1 year

• Serum PSA

  Up to 1 year

• Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies)

  Up to 15 years

• Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay)

  Up to 1 year

• Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score

  Up to 1 year

Study Arms (2)

Arm I (control)

NO INTERVENTION

Patients receive no intervention.

Arm II (fish oil)

EXPERIMENTAL

Patients receive dietary counseling with research dietitian weekly for 1 month and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a low omega-6, high omega-3 fat diet combined with fish oil. Patients also receive 4 fish oil capsules per day PO for 1 year.

Behavioral: behavioral dietary intervention; Dietary Supplement: omega-3 fatty acid; Other: laboratory biomarker analysis

Interventions

behavioral dietary intervention BEHAVIORAL

Receive dietary counseling

Arm II (fish oil)

omega-3 fatty acid DIETARY_SUPPLEMENT

Given PO

Also known as: fish oil, n-3 fatty acid, O3FA

Arm II (fish oil)

laboratory biomarker analysis OTHER

Correlative studies

Arm II (fish oil)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Pharmavite LLC: collaborator
• Seafood Industry Research Fund: collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Aronson WJ, Grogan T, Liang P, Jardack P, Liddell AR, Perez C, Elashoff D, Said J, Cohen P, Marks LS, Henning SM. High Omega-3, Low Omega-6 Diet With Fish Oil for Men With Prostate Cancer on Active Surveillance: The CAPFISH-3 Randomized Clinical Trial. J Clin Oncol. 2025 Mar;43(7):800-809. doi: 10.1200/JCO.24.00608. Epub 2024 Dec 13.

  PMID: 39671538 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Study Officials

• William Aronson

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 27, 2014
• Study Start: November 1, 2014
• Primary Completion: April 19, 2023
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 10, 2025

Record last verified: 2024-08

Locations

US (1)