Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adenocarcinoma of the Prostate
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 50 years and 80 years
Gender
Only males

Description

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) interven...

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.

Tracking Information

NCT #
NCT02176902
Collaborators
  • National Cancer Institute (NCI)
  • Pharmavite LLC
  • Seafood Industry Research Fund
Investigators
Principal Investigator: William Aronson Jonsson Comprehensive Cancer Center