Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
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.
Interventions
DIETARY_SUPPLEMENTgreen tea
6 cups of green tea daily for 2-8 weeks
DIETARY_SUPPLEMENTplacebo
6 cups of water daily for 2-8 weeks
DIETARY_SUPPLEMENTdecaffeinated black tea
6 cups of decaffeinated black tea daily for 2-8 weeks
Sponsors
National Cancer Institute (NCI)
Jonsson Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I - Green Tea Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
green tea: 6 cups of green tea daily for 2-8 weeks | 34 |
| Arm II - Water Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: 6 cups of water daily for 2-8 weeks | 33 |
| Arm III - Decaffeinated Black Tea Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks | 26 |
| Total | 93 |
Baseline characteristics
| Characteristic | Arm II - Water | Total | Arm I - Green Tea | Arm III - Decaffeinated Black Tea |
|---|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 6.2 | 61.8 years STANDARD_DEVIATION 6.8 | 62.1 years STANDARD_DEVIATION 6.9 | 61.4 years STANDARD_DEVIATION 7.4 |
| Biopsy Gleason Score (percent) 6 | 12 participants | 41 participants | 18 participants | 11 participants |
| Biopsy Gleason Score (percent) 7 (3+4) | 15 participants | 33 participants | 9 participants | 9 participants |
| Biopsy Gleason Score (percent) 7 (4+3) | 3 participants | 9 participants | 3 participants | 3 participants |
| Biopsy Gleason Score (percent) greater than or equal to 8 | 3 participants | 10 participants | 4 participants | 3 participants |
| BMI (kg/m^2) | 27.4 kg/m^2 STANDARD_DEVIATION 4.9 | 27.3 kg/m^2 STANDARD_DEVIATION 4 | 27.2 kg/m^2 STANDARD_DEVIATION 3.8 | 27.4 kg/m^2 STANDARD_DEVIATION 3.6 |
| Height (cm) | 175 cm STANDARD_DEVIATION 22 | 175.3 cm STANDARD_DEVIATION 22 | 176 cm STANDARD_DEVIATION 21 | 175 cm STANDARD_DEVIATION 22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 18 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 8 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 63 Participants | 27 Participants | 13 Participants |
| Region of Enrollment United States | 33 participants | 93 participants | 34 participants | 26 participants |
| Serum prostate-specific antigen (PSA) | 9.9 ng/mL STANDARD_DEVIATION 8.5 | 9.6 ng/mL STANDARD_DEVIATION 6 | 9.6 ng/mL STANDARD_DEVIATION 5.2 | 9.2 ng/mL STANDARD_DEVIATION 4.3 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 33 Participants | 93 Participants | 34 Participants | 26 Participants |
| Weight (KG) | 86.6 kg STANDARD_DEVIATION 14.3 | 87.6 kg STANDARD_DEVIATION 14 | 85.7 kg STANDARD_DEVIATION 12.2 | 89.9 kg STANDARD_DEVIATION 13.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 33 | 0 / 26 |
| other Total, other adverse events | 0 / 34 | 0 / 33 | 0 / 26 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 | 0 / 26 |
Outcome results
Primary
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.
Time frame: 6 weeks
Population: subjects that completed study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I - Green Tea | 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. | Staining apoptosis Tunel | 6.96 percent positive of total cells | Standard Deviation 8.56 |
| Arm I - Green Tea | 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. | NFKB cytoplasmic staining | 21.23 percent positive of total cells | Standard Deviation 20.46 |
| Arm I - Green Tea | 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. | Staining Proliferation Bax | 37.4 percent positive of total cells | Standard Deviation 11 |
| Arm I - Green Tea | 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. | Staining oxidative DNA Damage 8OHdG | 5.5 percent positive of total cells | Standard Deviation 7.4 |
| Arm I - Green Tea | 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. | Staining proliferation (Ki67) | 2.48 percent positive of total cells | Standard Deviation 1.83 |
| Arm I - Green Tea | 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. | NFkB nuclear staining | 1.46 percent positive of total cells | Standard Deviation 1.79 |
| Arm I - Green Tea | 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. | Staining Proliferation Bcl-2 | 2.92 percent positive of total cells | Standard Deviation 2.97 |
| Arm II - Water | 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. | Staining Proliferation Bcl-2 | 5.21 percent positive of total cells | Standard Deviation 6.91 |
| Arm II - Water | 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. | NFkB nuclear staining | 5.13 percent positive of total cells | Standard Deviation 6.37 |
| Arm II - Water | 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. | Staining proliferation (Ki67) | 2.3 percent positive of total cells | Standard Deviation 1.55 |
| Arm II - Water | 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. | Staining apoptosis Tunel | 6.7 percent positive of total cells | Standard Deviation 9.1 |
| Arm II - Water | 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. | Staining oxidative DNA Damage 8OHdG | 7.27 percent positive of total cells | Standard Deviation 10.68 |
| Arm II - Water | 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. | Staining Proliferation Bax | 37.06 percent positive of total cells | Standard Deviation 8.71 |
| Arm II - Water | 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. | NFKB cytoplasmic staining | 22.3 percent positive of total cells | Standard Deviation 14.62 |
| Arm III - Decaffeinated Black Tea | 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. | NFKB cytoplasmic staining | 19.21 percent positive of total cells | Standard Deviation 14.63 |
| Arm III - Decaffeinated Black Tea | 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. | Staining Proliferation Bax | 37.35 percent positive of total cells | Standard Deviation 7.58 |
| Arm III - Decaffeinated Black Tea | 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. | Staining proliferation (Ki67) | 4.38 percent positive of total cells | Standard Deviation 4.1 |
| Arm III - Decaffeinated Black Tea | 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. | Staining Proliferation Bcl-2 | 6.48 percent positive of total cells | Standard Deviation 6.25 |
| Arm III - Decaffeinated Black Tea | 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. | NFkB nuclear staining | 4.58 percent positive of total cells | Standard Deviation 6.61 |
| Arm III - Decaffeinated Black Tea | 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. | Staining oxidative DNA Damage 8OHdG | 11.23 percent positive of total cells | Standard Deviation 12.01 |
| Arm III - Decaffeinated Black Tea | 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. | Staining apoptosis Tunel | 6.57 percent positive of total cells | Standard Deviation 8.85 |
Secondary
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
Time frame: 6 weeks
Population: Urine concentration of (-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4-O-methylEGCG (4-OmethylEGCG).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I - Green Tea | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | EGC | 9.2 umol/g creatinine | Standard Deviation 16 |
| Arm I - Green Tea | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | EC | 4.8 umol/g creatinine | Standard Deviation 6.1 |
| Arm I - Green Tea | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | 4'-MeEGC | 8.0 umol/g creatinine | Standard Deviation 18 |
| Arm I - Green Tea | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | Theaflavins | 0 umol/g creatinine | Standard Deviation 0 |
| Arm II - Water | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | Theaflavins | 0 umol/g creatinine | Standard Deviation 0 |
| Arm II - Water | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | EGC | 0 umol/g creatinine | Standard Deviation 0 |
| Arm II - Water | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | 4'-MeEGC | 0 umol/g creatinine | Standard Deviation 0 |
| Arm II - Water | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | EC | 0 umol/g creatinine | Standard Deviation 0 |
| Arm III - Decaffeinated Black Tea | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | Theaflavins | 0 umol/g creatinine | Standard Deviation 0 |
| Arm III - Decaffeinated Black Tea | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | EC | .3 umol/g creatinine | Standard Deviation 0.3 |
| Arm III - Decaffeinated Black Tea | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | 4'-MeEGC | .2 umol/g creatinine | Standard Deviation 0.3 |
| Arm III - Decaffeinated Black Tea | Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). | EGC | .4 umol/g creatinine | Standard Deviation 0.4 |
Secondary
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.
Time frame: 6 weeks
Population: Concentration of tea polyphenols and methyl-metabolites in prostate tissue after the consumption of GT and BT. No polyphenols were found after water consumption.~(-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4-O-methylEGCG (4-OmethylEGCG).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I - Green Tea | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | 4 MeEGCG | 38.9 (pmol/g tissue) | Standard Deviation 19.5 |
| Arm I - Green Tea | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | ECG | 17.8 (pmol/g tissue) | Standard Deviation 10.1 |
| Arm I - Green Tea | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | EGCG | 42.1 (pmol/g tissue) | Standard Deviation 32.4 |
| Arm I - Green Tea | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | Theaflavin | 0 (pmol/g tissue) | Standard Deviation 0 |
| Arm II - Water | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | ECG | 0 (pmol/g tissue) | Standard Deviation 0 |
| Arm II - Water | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | EGCG | 0 (pmol/g tissue) | Standard Deviation 0 |
| Arm II - Water | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | Theaflavin | 0 (pmol/g tissue) | Standard Deviation 0 |
| Arm II - Water | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | 4 MeEGCG | 0 (pmol/g tissue) | Standard Deviation 0 |
| Arm III - Decaffeinated Black Tea | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | EGCG | 0 (pmol/g tissue) | Standard Deviation 0 |
| Arm III - Decaffeinated Black Tea | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | Theaflavin | 0 (pmol/g tissue) | Standard Deviation 0 |
| Arm III - Decaffeinated Black Tea | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | 4 MeEGCG | 0 (pmol/g tissue) | Standard Deviation 0 |
| Arm III - Decaffeinated Black Tea | Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue | ECG | 0 (pmol/g tissue) | Standard Deviation 0 |
Secondary
Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT).
Time frame: 6 weeks
Population: Pre and post blood samples unavailable for: 4 participants in Arm I (GT group), 3 participants in Arm II (control/water group) and 3 participants in Arm III (BT group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I - Green Tea | Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT). | 8.4 ng/mL | Standard Deviation 4.3 |
| Arm II - Water | Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT). | 10.0 ng/mL | Standard Deviation 9 |
| Arm III - Decaffeinated Black Tea | Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT). | 9.6 ng/mL | Standard Deviation 6 |