Berlin, Germany—A food supplement containing pomegranate seeds, green tea, broccoli, and turmeric—called Pomi-T (natureMedical)—taken twice daily significantly lowered prostate-specific antigen (PSA) levels versus placebo in men with localized prostate cancer, according to the results of a double-blind, placebo-controlled clinical trial. Use of the supplement allowed more men to remain on observation alone, according to results of a new study presented at the 2013 meeting of the Multinational Association of Supportive Care in Cancer.
Phase 2 clinical studies have demonstrated that polyphenol-rich foods, such as those found in Pomi-T, have anticancer effects. This new, independent study (ie, not funded by the manufacturers of Pomi-T) is the first adequately powered, randomized, placebo-controlled phase 3 clinical trial of Pomi-T in men with localized prostate cancer.
The investigators enrolled 203 men (average age, 74 years) whose PSA levels were rising after radiotherapy or surgery for localized prostate cancer. They were managed with active surveillance (59%) or watchful waiting (41%) and were randomized to 2 capsules of Pomi-T daily or to placebo for 6 months.
At 6 months, the median rise in PSA levels was 14.7% in the Pomi-T group compared with 78.5% in the placebo group, a significant 63.8% difference. PSA levels were stable or lower than baseline in 46% of men using the supplement versus 14% of men taking placebo, a significant (P = .001) 32% difference.
At follow-up, 7.4% of the men taking Pomi-T required treatment with radiation, surgery, or androgen-deprivation therapy compared with 26% of the men in the placebo group (P = .01). No differences were found between the 2 groups in laboratory measurements of cholesterol, blood pressure, serum glucose, C-reactive protein, or adverse events.
Taking the supplement allowed the majority (92%) of the men to remain on active surveillance compared with 74% of those receiving placebo.
“These results are awesome. We didn’t expect such a big response. This can change practice, because men and their doctors look at their PSA as a deciding factor in whether to continue on active management,” stated lead investigator Robert J. Thomas, MD, Mb, Chb, Consultant Oncologist, Bedford Hospital National Health Service Trust, Cambridge, United Kingdom.
Of note, this supplement is well tolerated and may improve digestion and urinary symptoms, Dr Thomas said. Men are more amenable to taking a nutritional supplement than to receiving active drugs, especially hormone therapy. This agent does not appear to act on hormones.