A double-blind, placebo-controlled randomised trial evaluating the effect of a polyphenol-rich whole food supplement on PSA progression in men with prostate cancer--the U.K. NCRN Pomi-T study

R Thomas, M Williams, H Sharma, A Chaudry, P Bellamy, R Thomas, M Williams, H Sharma, A Chaudry, P Bellamy

Abstract

Background: Polyphenol-rich foods such as pomegranate, green tea, broccoli and turmeric have demonstrated anti-neoplastic effects in laboratory models involving angiogenesis, apoptosis and proliferation. Although some have been investigated in small, phase II studies, this combination has never been evaluated within an adequately powered randomised controlled trial.

Methods: In total, 199 men, average age 74 years, with localised prostate cancer, 60% managed with primary active surveillance (AS) or 40% with watchful waiting (WW) following previous interventions, were randomised (2:1) to receive an oral capsule containing a blend of pomegranate, green tea, broccoli and turmeric, or an identical placebo for 6 months.

Results: The median rise in PSA in the food supplement group (FSG) was 14.7% (95% confidence intervals (CIs) 3.4-36.7%), as opposed to 78.5% in the placebo group (PG) (95% CI 48.1-115.5%), difference 63.8% (P=0.0008). In all, 8.2% of men in the FSG and 27.7% in the PG opted to leave surveillance at the end of the intervention (χ2 P=0.014). There were no significant differences within the predetermined subgroups of age, Gleason grade, treatment category or body mass index. There were no differences in cholesterol, blood pressure, blood sugar, C-reactive protein or adverse events.

Conclusions: This study found a significant short-term, favourable effect on the percentage rise in PSA in men managed with AS and WW following ingestion of this well-tolerated, specific blend of concentrated foods. Its influence on decision-making suggests that this intervention is clinically meaningful, but further trials will evaluate longer term clinical effects, and other makers of disease progression.

Figures

Figure 1
Figure 1
Consort diagram highlighting the flow of patients through the National Cancer Research Network Pomi-T study.
Figure 2
Figure 2
Median percentage rise in PSA between men taking the food supplement versus placebo.
Figure 3
Figure 3
Subgroup analysis: median percentage change in PSA for the 121 men managed with active surveillance (AS).
Figure 4
Figure 4
Subgroup analysis: median percentage change in PSA for the 78 men managed with watchful watching (WW; PSA relapse following previous radiotherapy).

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