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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: green tea
* Dietary Supplement: placebo
* Dietary Supplement: decaffeinated black tea


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer