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You have accessJournal of UrologyProstate Cancer: Markers II1 Apr 2015

MP6-08 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF POMEGRANATE EXTRACT ON RISING PROSTATE SPECIFIC ANTIGEN (PSA) LEVELS IN MEN FOLLOWING PRIMARY THERAPY FOR PROSTATE CANCER

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    INTRODUCTION AND OBJECTIVES

    The primary objective of this study was to compare the effects of the daily consumption of pomegranate liquid extract on end-of-treatment PSA doubling time (PSADT) in male subjects with rising PSA levels after primary therapy for localized prostate cancer.

    METHODS

    A double blind, 52-week, placebo-controlled, multi-institutional study evaluated the effects of pomegranate liquid extract on serum PSA levels in prostate cancer patients who have had a detectable rise in serum PSA after undergoing primary therapy. The primary endpoint of this study was mean serum PSADT at end-of-treatment. An exploratory analysis sought to determine the interaction of manganese superoxide dismutase (MnSOD) AA genotype and pomegranate treatment on PSADT change. Patients consumed pomegranate liquid extract, pomegranate juice, or matching placebo daily until PSA progression criteria were met.

    RESULTS

    215 subjects were screened to obtain 183 eligible subjects from 18 study centers who were randomly assigned to the active and placebo groups with a ratio of 2:1 (extract N=102; placebo N=64; juice N=17). Median PSADT increased 4.5 months in the placebo group (11.1 to 15.6, p=0.0000), 1.6 months in the extract group (12.9 to 14.5, p=0.1258), and 7.6 months in the juice group (12.7 to 20.3, p=0.0041). Analysis of manganese superoxide dismutase (MnSOD) AA genotype subjects according to treatment arm showed that placebo AA genotype patients experienced a 1.8 month change in median PSADT (10.9 to 12.7 months, p=0.22), while extract patients experienced a 12 month change in median PSADT (13.6 to 25.6, p=0.03). Levels of urinary pomegranate metabolites were significantly higher in the extract and juice patients compared to placebo subjects (p=0.00000 for both UAG and DMEAG).

    CONCLUSIONS

    A significant prolongation in PSADT from baseline to post-treatment assessment was observed in both the treatment and placebo arms, however none of rate changes were statistically significant between the three groups. Analysis of the study cohort suggests that men with the MnSOD AA genotype may represent a group that is more sensitive to the anti-proliferative effects of pomegranate and other antioxidants on PSADT, however this finding requires prospective hypothesis testing and validation. Urinary measurements of pomegranate metabolites can serve as an indicator of pomegranate treatment compliance.

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