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A Phase II Randomized, Open-Label, Two-Arm Study of Green Tea and a Water Control in Men Scheduled for Prostatectomy


Phase 2
40 Years
75 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Phase II Randomized, Open-Label, Two-Arm Study of Green Tea and a Water Control in Men Scheduled for Prostatectomy


OBJECTIVES:

- To determine the effects of drinking 6 cups of green tea vs water for an average of 6
weeks prior to prostatectomy on prostate tumor grade and stage (i.e., biopsy and
prostatectomy specimen), margin status of prostatectomy specimen, biomarkers of
prostate cancer development and progression (i.e., serum prostate-specific antigen
[PSA], proliferation [Ki-67], apoptosis [TUNEL, Bax/Bcl-2 ratio], inflammation [NFkB],
and oxidative status [8OhdG/dG ratio]) in patients with adenocarcinoma of the prostate.

- To compare changes in prostate tissue biomarkers (prostate biopsy tissue vs
corresponding radical prostatectomy tissue).

- To determine the concentrations of total and free tea polyphenols (i.e., EGCG, EC, EGC,
ECG) and theaflavins, as well as 4'-O-methyl-epigallocatechin gallate (4'-O-MeEGC),
EGCG-4'-O-glucuronide, EGCG-4"-O-glucuronide, 3M4HPAA, 4HPAA, and 3,4DHPAA in human
serum, urine, and prostate tissue after green tea, black tea, and water consumption.

- To determine the subject's genotype of catechol-O-methyltransferase (COMT),
UDPglucuronosyltransferases (UGT1A1) and sulfotransferase (SULT1A1), and the effect of
the intervention on gene expression of COMT, UGTs, and SULTs in prostate tissue.

- To determine the antiproliferative effect on human serum before and after tea
supplementation in an ex vivo LNCaP cell culture assay and to investigate the mechanism
of the antiproliferative activity.

- To determine the effect of tea supplementation on serum IGF-1, IGFBP-3, testosterone,
SHBG, and DHEA-sulfate.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2
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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biomarkers of prostate cancer development and progression

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Susanne M. Henning, PhD, RD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000596162

NCT ID:

NCT00685516

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781