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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-01

Study Completion Date

2026-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm I (control)

Patients receive no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm II (fish oil)

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.

Group Type EXPERIMENTAL

behavioral dietary intervention

Intervention Type BEHAVIORAL

Receive dietary counseling

behavioral dietary intervention

Intervention Type BEHAVIORAL

Receive guidelines for low-fat diet

omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

Given PO

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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behavioral dietary intervention

Receive dietary counseling

Intervention Type BEHAVIORAL

behavioral dietary intervention

Receive guidelines for low-fat diet

Intervention Type BEHAVIORAL

omega-3 fatty acid

Given PO

Intervention Type DIETARY_SUPPLEMENT

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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fish oil n-3 fatty acid O3FA

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No