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The UK national Pomi-T RCT

CLINICAL TRIALS & HUMAN TESTING
07 May 2014
09:00 - 09:25
Chair person  Anne-Laure Tardy
Speaker(s)  Robert Thomas

Co-Authored by: Madeleine Williams, Habinda Sharma, Assim Chaudry, Pat Bellamy of The Primrose Research Unit, Bedford Hospital, UK

 

Background: Polyphenol rich foods such as pomegranate, green tea, broccoli and turmeric have demonstrated anti-neoplastic effects in cell lines and animal models including, anti-angiogenesis, pro-apoptotic and reduced proliferation. Although, some have been investigated in small phase II studies this combination has never been evaluated within an adequately powered NCRN certified RCT.

Methods: 203 men, aged 53-89 yrs (average 74 yrs), with histologically confirmed prostate cancer, 59% managed with primary active surveillance (AS) or 41% with watchful waiting with a progressive PSA relapse following previous radical interventions 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 randomised process produced no statistical difference in gleason grade, body mass index (BMI), treatment category, fasting cholesterol or blood pressure although there was a difference in average age, 71.8 yrs in the food supplement group (FSG) versus 76.4 years in the placebo group (PG).

Results Four patients withdrew after randomisation and of the remaining 199, the median rise in PSA in the FSG was 14.7% (95% CI 3.4-36.7%) as opposed to 78.5% in the PG (95% CI 48.1-115.5%). This difference of 63.8% produced a value of p=0.0008 using an ANCOVA analysis. The number of men with a stable PSA (lower or the same value) at trial completion was 46% in the FSG as opposed to 14% in the PG (32% difference, chi2 at 1 DF = 19.58, p=0.00001). There were no significant differences in PSA% change in the predetermined subgroup analysis of age, gleason grade, treatment category or 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 most common (17%) in the FSG but 8% of these included an improvement in stool quality.

Conclusions: This study found a statistically significant short term favourable effect on the percentage rise in PSA in this cohort of men with prostate cancer managed with AS or WW following ingestion of this well tolerated specific blend of concentrated foods. Future trials are underway looking at the longer term clinical benefits particularly in terms of preventing medical intervention.

Who Should Attend and why:

Any delegate interested to learn about lifstyle and dietary factors which cause or help prostate cancer.

Those interested to see how a government approved scientific study has been designed, funded, approved and completed involving a whole food supplement

Those interested to learn how the results of this evaluation of Pomi-T could be incorporated into practical daily lifestyle choices

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