A double-blind, placebo RCT evaluating the effect of a polyphenol-rich whole food supplement on PSA progression in men with prostate cancer: The U.K. National Cancer Research Network (NCRN) Pomi-T study.

5008 Background: Polyphenol-rich foods such as pomegranate, green tea, broccoli and turmeric have demonstrated anti-neoplastic effects in cell lines and animal models. Although some have been investigated in small phase II studies, this combination had never been evaluated within an adequately powered nationally certified RCT. Methods: 203 men, average age 74 yrs, had localised prostate cancer, 59% managed with active surveillance and 41% with watchful waiting (progressive PSA relapse following previous radical interventions). They were randomised to receive a b.d. oral capsule containing a blend of pomegranate seed, green tea, broccoli and turmeric or an identical placebo for 6 months. The groups were statistically balanced in terms of gleason grade, body mass index (BMI), treatment category and fasting cholesterol although there was a difference in average age at baseline; 71.8 yrs in the food supplement group (FSG) versus 76.4 years in the placebo group (PG). Four men withdrew after randomisation. Results: The median rise in PSA in the FSG was 14.7% (95% CI 3.4-36.7%) versus 78.5% in the PG (95% CI 48.1-115.5%) (63.8% difference, ANCOVA analysis of covariance, p=0.0008). 46% of men had stable or lower PSA at trial completion in the FSG versus 14% in the PG (32% difference, chi 2 , p=0.00001). There were no significant differences in PSA% change within the predetermined subgroups (age, gleason grade, treatment category, BMI). There were no differences in cholesterol, blood pressure, blood sugar or c-reactive protein. 24% men recorded events in the FSG and 34% in the PG (non significant). Mild gastro-intestinal effects were (17%) in the FSG but 8% of these reported an improvement in stool quality. Conclusions: This study found a statistically significant short-term favourable effect on the percentage rise in PSA in these men managed with observation following intake of this specific food supplement. Although many men would see this as useful addition to their self help strategies, future trials should look at the longer-term clinical benefits particularly in terms of preventing medical intervention. Clinical trial information: 81263.