Corresponding abstract:

Clin Cancer Res. 2006 Jul 1;12(13):4018-26.
Phase II study of pomegranate juice for men with rising prostate-specific
antigen following surgery or radiation for prostate cancer.
Pantuck AJ, Leppert JT, Zomorodian N, Aronson W, Hong J, Barnard RJ, Seeram
N, Liker H, Wang H, Elashoff R, Heber D, Aviram M, Ignarro L, Belldegrun A.
Department of Urology, David Geffen School of Medicine, University of
California at Los Angeles, Los Angeles, California 90095-1738, USA.

PURPOSE: Phytochemicals in plants may have cancer preventive benefits
through antioxidation and via gene-nutrient interactions. We sought to
determine the effects of pomegranate juice (a major source of antioxidants)
consumption on prostate-specific antigen (PSA) progression in men with a
rising PSA following primary therapy. EXPERIMENTAL DESIGN: A phase II, Simon
two-stage clinical trial for men with rising PSA after surgery or
radiotherapy was conducted. Eligible patients had a detectable PSA > 0.2 and
< 5 ng/mL and Gleason score < or = 7. Patients were treated with 8 ounces of
pomegranate juice daily (Wonderful variety, 570 mg total polyphenol gallic
acid equivalents) until disease progression. Clinical end points included
safety and effect on serum PSA, serum-induced proliferation and apoptosis of
LNCaP cells, serum lipid peroxidation, and serum nitric oxide levels.
RESULTS: The study was fully accrued after efficacy criteria were met. There
were no serious adverse events reported and the treatment was well
tolerated. Mean PSA doubling time significantly increased with treatment
from a mean of 15 months at baseline to 54 months posttreatment (P < 0.001).
In vitro assays comparing pretreatment and posttreatment patient serum on
the growth of LNCaP showed a 12% decrease in cell proliferation and a 17%
increase in apoptosis (P = 0.0048 and 0.0004, respectively), a 23% increase
in serum nitric oxide (P = 0.0085), and significant (P < 0.02) reductions in
oxidative state and sensitivity to oxidation of serum lipids after versus
before pomegranate juice consumption. CONCLUSIONS: We report the first
clinical trial of pomegranate juice in patients with prostate cancer. The
statistically significant prolongation of PSA doubling time, coupled with
corresponding laboratory effects on prostate cancer in vitro cell
proliferation and apoptosis as well as oxidative stress, warrant further
testing in a placebo-controlled study. PMID: 16818701

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