Final results from a trial of a combination herbal supplement for biochemically recurrent prostate cancer.

Abstract

e16020 Background: No standard exists for the treatment of bcrPC. Concern over deleterious effects of androgen deprivation (ADT) and lack of proven survival benefit in this setting makes initiation of ADT inappropriate for some patients. A non-hormonal, non-toxic agent to reduce PSA would be a welcome alternative to observation. We tested Prostate Health Cocktail (PHC), a supplement containing vitamin D & E, saw palmetto, lycopene, green tea and soy extracts, in this population, to see whether it could decrease PSA. Methods: Eligible men had a rising PSA with doubling time between 3 and 36 months, with no evidence of metastases on CT and bone scan. After IRB approval, 40 men were treated with PHC 3 capsules PO daily for 4 week cycles. PSA was repeated after cycle 1, then every 2 cycles thereafter with imaging only as clinically indicated; the primary endpoint was PSA decline. 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: 60 men screened, 17 failed (28%). Median age was 67 (range 54-84) and baseline PSA 2.8 ng/mL (1.1-84.1). 23% had primary radiation only, 25% had prostatectomy, and 52% had both; 23% had Gleason 8-10. The median # of cycles was 8 (1-13). 15/40 men (37.5%) had a PSA decline (1.1%-55% maximum decrease). 43% stopped therapy for PSA progression, with median time to progression 10.2 months. Circulating tumor cells were detected in 5 of the first 23 subjects; complete CTC data will be presented. There was no significant change in testosterone or DHT during treatment. Toxicities possibly related to PHC included grade 1 or 2 liver enzyme elevations [transient], grade 1 or 2 gastrointestinal symptoms (9), grade 1 weakness/dizziness/pain (5), and grade 1 fatigue (2). 5 men continue on study, 3 lost to f/u, 16 have developed metastases, median time to mets 31.5 months from bcr. Conclusions: PHC induced PSA declines in 37% of patients with bcrPC, and was not associated with changes in serum androgens or significant toxicities. PHC is a potential alternative to observation in select patients with bcrPC. Clinical trial information: NCT00669656.