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

Not Applicable

Active, not recruiting

• Conditions: Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

• Registration Number: NCT02176902
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-6-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 107

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients sign the informed consent<br><br> - Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has<br> adenocarcinoma of the prostate<br><br> - Patient elects to undergo active surveillance<br><br> - Clinical stage T2c or less<br><br> - Gleason grade 3+4 or less<br><br> - PSA < 25<br><br> - Geographically able to have study visits at the University of California, Los<br> Angeles (UCLA) Clinical Research Unit<br><br> - Subjects are willing to not consume lycopene, green tea or pomegranate supplements<br> or pomegranate juice during the 1-year study<br><br> - If subjects are randomized to the control group they agree to not consume fish oil<br> capsules during the 1-year study<br><br>Exclusion Criteria:<br><br> - Diagnostic prostate biopsy with only 1 core with cancer and < 5% of tissue from that<br> core involved with cancer<br><br> - Patient has taken finasteride or dutasteride during the prior year<br><br> - Patient has taken fish oil during the prior 3 months<br><br> - Patient had prior treatment for prostate cancer (surgery, radiation, local ablative<br> therapy, anti-androgen therapy or androgen deprivation therapy)<br><br> - Patient has other medical conditions that exclude him from undergoing a repeat<br> prostate biopsy at 1-year<br><br> - Patient has allergy to fish

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ki-67 index

Secondary Outcome Measures

Name	Time	Method
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);Serum PSA;Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies);Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay);Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score;Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count;Incidence of adverse events graded according to National Cancer Institute Common Toxicity Criteria version 4.0;Sample storage for future research