961 - Updated Analysis of a Combination Herbal Supplement Trial in Biochemically Recurrent Prostate Cancer

Abstract

ABSTRACT Background After curative local therapy, thousands of men will experience rising PSA as an early indicator of recurrent prostate cancer. For these men no standard of care exists, and concern over serious side effects of androgen deprivation (ADT) makes delaying ADT common. We tested Prostate Health Cocktail (PHC), which contains vitamins D & E, saw palmetto, lycopene, green tea and soy extracts, in this population, to see whether it could induce PSA declines. Methods Eligible men had a rising PSA with doubling time (DT) between 3 and 36 months, with no evidence of metastases on CT and bone scan. Treatment included PHC 3 capsules PO daily for 4 week cycles for a maximum of 1 year. PSA was repeated after 1 cycle and then every 2 cycles thereafter with imaging only as clinically indicated; the primary endpoint was PSA decline at 12 weeks. PSA progression was defined as 25% increase above baseline/nadir and absolute increase of 5 ng/mL or return to baseline. Circulating tumor cells (CTCs) were measured at baseline and after 3 cycles using parylene membrane filters. Results A total of 36 patients were enrolled as of January 31, 2012; 3 were retrospectively classified as ineligible and were excluded from all analyses except for toxicity. The median age was 67 (range 54-85) and baseline PSA was 2.9 ng/mL (1.1-53.2). The median number of cycles was 8 (1-13). Stable PSA was the best response for 25/27 men assessable at 12 weeks (93%) and 11/33 men (33%) had a PSA decline (1.1%-49.0% decrease). There was no significant change in testosterone or DHT during treatment. Circulating tumor cells were detected in some of the subjects. One patient had grade 3 transaminitis in the setting of alcohol consumption, otherwise the toxicities were limited to grade 1 or 2 and related to the gastrointestinal and metabolic/laboratory systems. Conclusion PHC demonstrated activity in men with biochemical recurrence, resulting in PSA declines in about a third of cases, and was not associated with changes in serum androgens or significant toxicities. For the first time, we are reporting that circulating tumor cells can be detected in men with biochemical recurrence using filter technology. Disclosure J. Pinski: I am a co-owner of OncoNatural Solutions Inc, the company which produces the Prostate Heath Coctail (PHC). All other authors have declared no conflicts of interest.