low-fat diet and fish oil in men on active surveillance for prostate cancer

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

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.

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