Clinical trial NCT02176902: Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Pharmavite LLC
name: Seafood Industry Research Fund
First posted: 2014-06-27
Enrollment: 107
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: PRIMARY OBJECTIVES:

I. 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:

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 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.

Eligibility 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 \< 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

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

Primary outcomes:
measure: Ki-67 index
timeFrame: 1 year
Secondary outcomes:
measure: 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)
timeFrame: 1 year
measure: Serum PSA
timeFrame: Up to 1 year
measure: Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies)
timeFrame: Up to 15 years
measure: Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay)
timeFrame: Up to 1 year
measure: Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score
timeFrame: Up to 1 year
measure: Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count
timeFrame: Up to 1 year
measure: Incidence of adverse events graded according to National Cancer Institute Common Toxicity Criteria version 4.0
timeFrame: Up to 1 year
measure: Sample storage for future research
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: William Aronson
role: PRINCIPAL_INVESTIGATOR
References: