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

Not Applicable

Completed

Conditions: Prostate Cancer

Interventions: Dietary Supplement: green tea
Dietary Supplement: decaffeinated black tea
Dietary Supplement: placebo

Registration Number: NCT00685516

Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary: RATIONALE: Green tea contains ingredients that may prevent or slow the growth of certain cancers. It is not yet known whether green tea is more effective than black tea or water in treating prostate cancer.

PURPOSE: This randomized phase II trial is studying green tea to see how well it works compared with black tea and water in treating patients with prostate cancer undergoing surgery.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 113

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I - Green Tea	green tea	Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
Arm III - Decaffeinated black tea	decaffeinated black tea	Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
Arm II - Water	placebo	Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Effect of Green Tea (GT) and Black Tea (BT) Consumption on Percentage of Cells With Positive Staining for Apoptosis, Proliferation, Oxidation, and Inflammation in Malignant Radical Prostatectomy Tissue Compared to Water Control Using Immunohistochemistry.	6 weeks	To determine the effect of Green Tea and Black Tea consumption on Prostate cancer tissue by examining programmed cell death, cell proliferation, cell oxidation, and cellular inflammation in that malignant radical prostatectomy tissue compared to water control using immunohistochemistry.

Secondary Outcome Measures

Name	Time	Method
Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue	6 weeks	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.
Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).	6 weeks	Concentration of tea polyphenols and methyl-metabolites in urine after the consumption of GT and BT. No polyphenols were found after water consumption
Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT).	6 weeks

Trial Locations

Locations (2): Veterans Affairs Medical Center - West Los Angeles
🇺🇸
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸
Los Angeles, California, United States