Shannon 2010.

Study name	Fish oil and green tea extract in preventing prostate cancer in patients who are at risk for developing prostate cancer ClinicalTrial ID: Shannon 2010
Methods	Randomised, double‐blind, placebo‐controlled study
Participants	Men at high risk of prostate cancer Participants are stratified according to age (< 65 vs ≥ 65)
Interventions	Intervention group A: GTE polyphenols (75%) and EGCG (at least 30% = 300 mg) per 1000 mg capsule (2 capsules/d) Intervention group B: fish oil capsule per 1000 mg with ethyl esters of eicosapentaenoic acid (20:5n‐3) and docosahexanoic acid (3 capsules/d) Intervention group C: A+B Control group: placebo, olive oil capsule 2/3 times/d Duration: 12 weeks
Outcomes	Primary outcomes Fatty acid synthase expression by immunohistochemistry at pre‐ and post‐intervention (FAS Summary Score) Cell proliferation by Ki67‐immunohistochemistry at pre‐ and post‐intervention Incidence of prostate cancer
Starting date	July 2005
Contact information	Jackie Shannon, Principal Investigator, OHSU Knight Cancer Institute
Notes	According to 2010 abstract 67 men completed the study, 4 were enrolled. Anticipated sample size 120 men, or 30 men/group

EGCG: epigallocatechin‐3‐gallate; ESCC: (o)esophageal squamous cell carcinoma; FAS: fatty acid synthase; GTE: green tea extract; RCT: randomised controlled trial