Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer
This randomized phase II trial will evaluate if a low-fat diet with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.
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
- If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study
- ELIGIBILITY FOR THE 2-YEAR EXTENSION
- Completed the 1-year phase II low-fat fish oil study
- Signed the 2 year extension study informed consent
- Have a PSA < 25
- Are geographically able to have study visits at UCLA’s Warren Hall or the Clinical Translational Research Center
- If continuing in the Control Group portion, agree to not consume fish oil during the duration of the 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 6 months
- Patient has significant medical or psychiatric conditions that would make the patient a poor protocol candidate
- Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)
- Patient has allergy to fish or is a vegetarian
- If patient participates in fecal collection for microbiome studies, exclude if antibiotics taken 4-weeks prior to collection
- ELIGIBILITY FOR THE 2-YEAR EXTENSION: Patient is currently taking finasteride or dutasteride
- ELIGIBILITY FOR THE 2-YEAR EXTENSION: Patient has a significant medical or psychiatric condition that would make the patient a poor protocol candidate
- ELIGIBILITY FOR THE 2-YEAR EXTENSION: Patient has had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02176902.
PRIMARY OBJECTIVE:
I. To determine if a 1-year low-fat fish oil (omega-3 fatty acid) intervention results in decreased prostate cancer Ki67 index as compared to a control group in men on active surveillance.
SECONDARY OBJECTIVES:
I. To 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), serum prostate-specific antigen (PSA), and long-term clinical outcomes (clinical progression, prostate cancer therapies).
II. To evaluate potential surrogate biomarkers of progression (red blood cell [RBC] membrane fatty acid analyses, ex-vivo bioassay).
III. To determine if a correlation exists between free fatty acid receptor 4 (GPR120) levels and progression markers in response to the LF/FO intervention.
IV. Change in National Comprehensive Cancer Network (NCCN) risk group
V. To evaluate compliance with a 1-year + 2-year extension LF/FO intervention.
VI. To evaluate safety of a 1-year + 2-year extension LF/FO intervention.
VII. To evaluate the effect of LF/FO intervention on composition of intestinal microbiota.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive no intervention. Patients participating in optional 2-year extension study continue their usual dietary habits.
ARM II: Patients receive dietary counseling with a research dietitian twice during month 1 and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a low-fat diet comprising 25% 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. Patients participating in optional 2-year extension study receive dietary counseling with a dietitian or dietitian assistant every 3 months in-person or via telephone and 3 fish oil capsules daily for 2 years.
After completion of study, patients are followed up yearly for 15 years.
Trial PhasePhase II
Trial Typeprevention
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorWilliam Aronson
- Primary ID13-000432
- Secondary IDsNCI-2014-01257
- ClinicalTrials.gov IDNCT02176902