Phase II study of pomegranate juice for men with rising prostate-specific antigen following surgery or radiation for prostate c

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Clin Cancer Res. 2006 Jul 1;12(13):4018-26.

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.

of Urology, David Geffen School of Medicine, University of California
at Los Angeles, Los Angeles, California 90095-1738, USA.

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.
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.