Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery

OBJECTIVES:

- to determine the effect of GT and BT consumption on apoptosis (TUNEL, ratio Bax:Bcl-2),
proliferation, oxidation, and inflammation in malignant radical prostatectomy tissue
compared to water control using immunohistochemistry.

- to examine levels of tea polyphenols and methylated tea polyphenol metabolites in fresh
frozen radical prostatectomy tissue and urine, urinary oxidative DNA damage (8OHdG) and
serum prostate-specific antigen (PSA) levels.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 3 treatment
arms.

- Arm I: Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of
unacceptable toxicity.

- Arm II: Patients receive 6 cups of water daily for 2-8 weeks in the absence of
unacceptable toxicity.

- Arm III: Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the
absence of unacceptable toxicity.

Patients undergo radical prostatectomy.

Blood and urine samples, as well as tissue from diagnostic biopsy and radical prostatectomy
specimens, are obtained for laboratory correlative studies. Samples are assessed by IHC,
high-performance liquid chromatography, or mass spectrometry for changes in prostate tumor
grade, stage, and margin status; concentrations of total and free tea polyphenols (i.e.,
EGCG, EC, EGC, ECG), theaflavins, and conjugated/colonic tea metabolites; biomarkers of
prostate cancer development and progression (i.e., serum PSA, proliferation [i.e., Ki-67],
apoptosis [i.e., TUNEL, Bax/Bcl-2 ratio], inflammation [i.e., NFkB]), and oxidative status
(i.e., 8OhdG/dG ratio); and genotype and gene expression of metabolizing enzymes (i.e., COMT,
UGT, and SULT). Serum samples are also assessed by ex vivo LNCaP cell culture assay for
antiproliferative activity and by competitive chemiluminescent immunoassay for concentrations
of PSA, IGF-1, IGFBP-3, testosterone, SHBG, and DHEA-sulfate.

Inclusion Criteria:

- subject consents to participate in the trial.

- subject is 40-75 years of age and has a diagnosis of adenocarcinoma of the prostate.

- Scheduled to undergo radical prostatectomy.

- The subject agrees to stop consumption of tea or tea-containing products throughout
the entire intervention period except for the tea provided during study intervention.

- The subject agrees to stop consumption of dietary or vitamin supplements (e.g.,
lycopene, Vitamin E, selenium, genistein) or herbal supplements (e.g., saw palmetto,
PC-SPES)

Exclusion Criteria:

- history of hepatitis or liver dysfunction

- ongoing alcohol abuse

- significant medical or psychiatric conditions that would make the patient a poor
protocol candidate

- prior sensitivity or allergic reaction to tea, tea products, or tea supplements

- allergy or sensitivity to multiple food items or nutritional supplements

- concurrent luteinizing hormone-releasing hormone agonists, androgen receptor blocking
agents, or finasteride

- prior bilateral orchiectomy