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

Effects of Brewed Green and Black Tea on Inflammation, Apoptosis and Oxidation in Men With Prostate Cancer

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Dietary supplement: green tea; Dietary supplement: placebo; Dietary supplement: decaffeinated black tea

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center at UCLA
    • Los Angeles, California, United States, 90073
      • Veterans Affairs Medical Center - West Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I - Green Tea; Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.	Dietary supplement: green tea; 6 cups of green tea daily for 2-8 weeks
Placebo Comparator: Arm II - Water; Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.	Dietary supplement: placebo; 6 cups of water daily for 2-8 weeks
Active Comparator: Arm III - Decaffeinated black tea; Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.	Dietary supplement: decaffeinated black tea; 6 cups of decaffeinated black tea daily for 2-8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Susanne M. Henning, PhD, RD, Jonsson Comprehensive Cancer Center

Publications and helpful links

General Publications

• Henning SM, Wang P, Said JW, Huang M, Grogan T, Elashoff D, Carpenter CL, Heber D, Aronson WJ. Randomized clinical trial of brewed green and black tea in men with prostate cancer prior to prostatectomy. Prostate. 2015 Apr 1;75(5):550-9. doi: 10.1002/pros.22943. Epub 2014 Dec 24.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2007
• Primary Completion (Actual): January 12, 2012
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 22, 2008
• First Submitted That Met QC Criteria: May 23, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer; adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 10-001050; R01CA116242 (U.S. NIH Grant/Contract); UCLA-061109702 (Other Identifier: UCLA); CDR0000596162 (Other Identifier: UCLA)