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

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.

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