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Alexandre de la Taille, Ralph Buttyan, Omar Hayek, Emilia Bagiella, Erica Golliday,
Ahmad Shabsigh, Tatjana Burchardt, Martin Burchardt, Aaron E. Katz. New York, NY

INTRODUCTION -- To evaluate PC-SPES activity, an herbal mixture, in prostate cancer cell lines, in xenograft tumors as well as in a prospective clinical trial in 69 prostate cancer (PCa) patients.

METHODS -- PC SPES was evaluated for its ability to decrease cell viability and to induce apoptosis on PCa cell lines (LNCaP, PC3 and DU145). PC3 tumor xenograft sizes were compared between orally treated and untreated male immunodeficient mice. PC-SPES therapy was started the same day of the tumor injection (6 mice control and 6 mice treated). Sixty-nine PCa patients (hormone-naive PCa n=4, hormone refractory PCa n=22, and other therapy n=43) were treated with 3 capsules PC-SPES of 320 mg/day. Serum PSA responses and side effects were evaluated.

RESULTS -- PC-SPES significantly decreased cell viabilities and increased apoptosis in cell lines. Immunodeficient mice xenografted with PC-3 had smaller tumor size when they were treated (931 89 mm3 vs1,424 685 mm3, p=0.23). The testis, and prostate-bladder-seminal vesicles of the treated mice were significantly reduced in weight in the treated group and had a higher apoptosis rate and less cell proliferation. Eighty-two percent of PCa patients treated with PC-SPES decreased their PSA at 2 months, 78% at 6 months and 88% at 12 months. PC-SPES had the same strong activity to decrease PSA in hormone-refractory PCa group (90% decreased their PSA at 2 months (n=21), 74% at 6 months (n=15), 100% at 12 months (n=6), 50% at 18 months (n=4), and 66% at 6 months (n=3). Side effects included nipple tenderness (42%), gynecomastia (8%), hot flashes (7%) and venous thrombosis (2%).

CONCLUSIONS -- PC-SPES, proved to be active in decreasing cell viabilities and in inducing apoptosis of PCa cells in vitro. Smaller tumor sizes were observed in PC3 xenograft tumors. The overwhelming majority of PCa patients treated with PC-SPES experienced a decrease in their serum PSA levels, but these patients also demonstrated side effects comparable to those seen in estrogen treatment.

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