Green Tea Extract in Treating Patients With Low-Risk Prostate Cancer

• Sponsor: Sanjay Gupta PhD (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01928485
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Actual Duration (Months): 38.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This randomized phase II trial studies how well green tea extract works in treating patients with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or slow the growth of certain cancers.

Condition or Disease	Intervention/Treatment	Phase
Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer	Other: active surveillance; Drug: Sunphenon; Other: laboratory biomarker analysis; Other: Questionnaire Administration	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To assess changes in the levels of total- and free- prostate-specific antigen (PSA), free to total PSA (f/tPSA) ratio and insulin-like growth factor 1 (IGF-I) levels and IGF-I/free PSA (fPSA) ratio, insulin-like growth factor binding protein 3 (IGFBP-3), and vascular endothelial growth factor (VEGF) after Sunphenon 90DCF-T (green tea extract) supplementation during the period between recruitment and biopsy.

SECONDARY OBJECTIVES:

1. To evaluate the effects of oral ingestion on Sunphenon 90DCF-T supplementation during the period between recruitment and biopsy in the reactivation of glutathione S-transferase pi 1 (GSTP1) (whole blood deoxyribonucleic acid [DNA]); levels of antigen identified by monoclonal antibody Ki-67 (Ki-67), cluster of differentiation 34 (CD34), and M30 apopotosense in the prostate tissue.

2. To evaluate the effects of oral ingestion of Sunphenon 90DCF-T during the period between recruitment and biopsy on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture and quality of life (QOL) assessment.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients undergo active surveillance for 52 weeks.

ARM B: Patients receive green tea extract orally (PO) once daily (QD) for 52 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Study of Sunphenon Decaffeinated Capsules in Men With Low-Risk Prostate Cancer on Active Surveillance
• Actual Study Start Date: Aug 30, 2013
• Actual Primary Completion Date: Oct 5, 2016
• Actual Study Completion Date: Nov 7, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm A (active surveillance) Patients undergo active surveillance for 52 weeks.	Other: active surveillance; Undergo active surveillance; Other: laboratory biomarker analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Other Names: The Expanded Prostate Cancer Index Composite (EPIC-26) American Urological Association (AUA) symptom index Quality of Life (SF-12) Food Questionnaire
Experimental: Arm B (Sunphenon) Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.	Drug: Sunphenon; Given PO; Other Names: Green tea polyphenols Green tea extract Sunphenon 90DCD-T ; Other: laboratory biomarker analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Other Names: The Expanded Prostate Cancer Index Composite (EPIC-26) American Urological Association (AUA) symptom index Quality of Life (SF-12) Food Questionnaire

Outcome Measures

Primary Outcome Measures

1. Total-PSA (tPSA) Levels [From baseline at 52 weeks]

   tPSA serum levels

2. Changes in the f/tPSA Ratio [From baseline at 52 weeks]

   The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

3. Changes in IGF-I Levels [Baseline to 52 weeks]

   The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

4. Changes in the IGF-I/fPSA Ratio [Baseline up to 52 weeks]

   The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

5. Changes in the Level of IGFBP-3 [Baseline to 52 weeks]

   The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

6. Changes in the Level of VEGF [Baseline up to 52 weeks]

   The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

7. Changes in the Levels of Free-PSA (f-PSA) [from baseline at 52 weeks]

   The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

Secondary Outcome Measures

1. Effects of Oral Ingestion of Green Tea Extract in the Reactivation of GSTP1 (Whole Blood DNA) [Up to 52 weeks]

   The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures analysis of variance (ANOVA).

2. Effects of Oral Ingestion of Green Tea Extract on Levels of Ki-67 [Up to 52 weeks]

   The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.

3. Effects of Oral Ingestion of Green Tea Extract on Levels of CD34 [Up to 52 weeks]

   The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.

4. Effects of Oral Ingestion of Green Tea Extract on Levels of M30 Apoptosense in the Prostate Tissue [Up to 52 weeks]

   The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.

5. Effects of Oral Ingestion of Sunphenon 90 DCF-T on Histologic Findings in Prostate Tissue Such as Nuclear Measurements Viz. Shape, Size and Texture [Up to 52 weeks]

   Effects of oral ingestion of Sunphenon 90 DCF-T on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture

6. Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores [Baseline]

   Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.

7. Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores [At 24 weeks]

   Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.

8. Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores [at 3.5 years from start of study]

   Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.

9. Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12) [Baseline]

   Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.

10. Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12) [At 24 weeks]

    Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.

11. Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12) [At 3.5 years from start of study]

    Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.

12. Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA) [Baseline]

    Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.

13. Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA) [At 24 weeks]

    Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.

14. Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA) [At 3.5 years from start of study]

    Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.

15. Sexual Health Inventory in Men Score (SHIM Score) [Baseline, at 24 weeks, and at 3.5 years from start of study]

    SHIM score - The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows: 22 - 25: No significant erectile dysfunction 17 - 21: Mild erectile dysfunction 12 - 16: Mild-to-moderate erectile dysfunction 8 - 11: Moderate erectile dysfunction 5 - 7: Severe erectile dysfunction Reported values are an average of three collected data points per participant: at baseline, at 24 weeks, and at end of study (3.5 years)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must be males with histologically confirmed and clinically localized low-grade and low-volume prostate cancer demonstrated at the time of initial diagnosis

• Prostate biopsy must be positive for cancer: clinically localized T1c or T2a, PSA ≤ 10, Gleason ≤ 6 at the time of initial diagnosis. As the intent of serial biopsy is to ensure that the disease has not progressed to the stage or grade of requiring treatment, the presence of a negative biopsy following an initial positive biopsy (coupled with clinically localized T1c or T2a PSA ≤10 and Gleason ≤6 for a patient who has had no treatment, will not render the patient ineligible. If the consecutive biopsy is either negative, or if positive and remains clinically localized T1c or T2a, PSA≤10 and Gleason ≤6, the patient is eligible

• Willing to refrain from the concurrent use of high-dose (200 mg or higher per day) of vitamins, antioxidants, Proscar, Advodart, and anti-inflammatory agents

• Willing to sign an Institutional Review Board (IRB)-approved informed consent document and adhere to the protocol

• Willing and able to take oral medications

• Willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea for the duration of the study

• Subjects must have newly diagnosed (within 1 year), previously untreated prostate cancer without other malignancy; therefore, no prior therapies are permitted

• Total bilirubin within normal institutional limits

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ institutional upper limit of normal

• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ institutional upper limit of normal

• Serum creatinine within normal institutional limits

• Subject must be willing to limit alcohol to moderate use which is defined as: up to one drink a day for women or two drinks a day for men; examples of one drink include:

• Beer: 12 fluid ounces (355 milliliters)

• Wine: 5 fluid ounces (148 milliliters)

• Distilled spirits (80 proof): 1.5 fluid ounces (44 milliliters)

Exclusion Criteria:

• Patients who are receiving any other investigational agents

• Patients with known concurrent malignancy

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Sunphenon 90 DCF-T or other agents used in this study

• Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization; or concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week

• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Patients who have received prior hormonal or surgical therapy for prostate cancer; including prior brachytherapy or radiation therapy

• Signs or symptoms of progressive or uncontrolled liver disease

• Known malignancy at any site within the last two years; with the exception of basal cell carcinoma (BCC)

• Participation in a research trial within the past three months

• Any condition that would interfere with the ability to give informed consent or comply with the study protocol

• Hypersensitivity to tea products or any of the inactive ingredients found in the drug product capsules

• Patients with a known history of Gilbert's syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065

Sponsors and Collaborators

• Sanjay Gupta PhD

Investigators

• Principal Investigator: Lee Ponsky, MD, Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanjay Gupta PhD, Co-Investigator, Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT01928485
• Other Study ID Numbers: CASE6812; NCI-2013-01372
• First Posted: Aug 26, 2013
• Last Update Posted: Oct 22, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Period Title: Overall Study
STARTED	4	2
COMPLETED	4	1
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)	Total
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Total of all reporting groups
Overall Participants	4	2	6
Age, Customized (Count of Participants)
50-59 years	0 0%	1 50%	1 16.7%
60-69 years	4 100%	1 50%	5 83.3%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	4 100%	2 100%	6 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	4 100%	2 100%	6 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 50%	0 0%	2 33.3%
White	2 50%	2 100%	4 66.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%	2 100%	6 100%

Outcome Measures

1. Primary Outcome

Title	Total-PSA (tPSA) Levels
Description	tPSA serum levels
Time Frame	From baseline at 52 weeks

Outcome Measure Data

Analysis Population Description

Participants with available PSA values

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
Mean (Standard Deviation) [ng/mL]	7.8 (2.29)	5.1 (NA)

2. Primary Outcome

Title	Changes in the f/tPSA Ratio
Description	The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Time Frame	From baseline at 52 weeks

Outcome Measure Data

Analysis Population Description

Participants with available PSA values

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	3	1
Mean (Standard Deviation) [ratio]	0.16 (0.07)	0.16 (NA)

3. Primary Outcome

Title	Changes in IGF-I Levels
Description	The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Time Frame	Baseline to 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	3	1
Mean (Standard Deviation) [ng/mL]	5.28 (0.1)	2.12 (NA)

4. Primary Outcome

Title	Changes in the IGF-I/fPSA Ratio
Description	The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Time Frame	Baseline up to 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	3	1
Mean (Standard Deviation) [ratio]	4.48 (0.77)	3.02 (NA)

5. Primary Outcome

Title	Changes in the Level of IGFBP-3
Description	The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Time Frame	Baseline to 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
Mean (Standard Deviation) [ng/mL]	1.82 (0.93)	5.54 (NA)

6. Primary Outcome

Title	Changes in the Level of VEGF
Description	The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Time Frame	Baseline up to 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
Mean (Standard Deviation) [pg/mL]	29.8 (20.6)	0 (NA)

7. Primary Outcome

Title	Changes in the Levels of Free-PSA (f-PSA)
Description	The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
Time Frame	from baseline at 52 weeks

Outcome Measure Data

Analysis Population Description

Participants with available PSA values

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	3	1
Mean (Standard Deviation) [ng/mL]	1.2 (0.17)	0.7 (NA)

8. Secondary Outcome

Title	Effects of Oral Ingestion of Green Tea Extract in the Reactivation of GSTP1 (Whole Blood DNA)
Description	The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures analysis of variance (ANOVA).
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
Mean (Standard Deviation) [ng/mL]	0.53 (0.14)	0.60 (0.23)

9. Secondary Outcome

Title	Effects of Oral Ingestion of Green Tea Extract on Levels of Ki-67
Description	The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

ROI staining scores could not be determined because no positive stained cells in post-biopsy specimens. Tissue from 3 participants in Arm A and 1 participant from Arm B was analysed.

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	0	0

10. Secondary Outcome

Title	Effects of Oral Ingestion of Green Tea Extract on Levels of CD34
Description	The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

ROI staining scores could not be determined because no positive stained cells in post-biopsy specimens. Tissue from 3 participants in Arm A and 1 participant from Arm B was analysed.

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	0	0

11. Secondary Outcome

Title	Effects of Oral Ingestion of Green Tea Extract on Levels of M30 Apoptosense in the Prostate Tissue
Description	The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

M30 levels could not be determined because there were no tumor cells in biopsy

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	0	0

12. Secondary Outcome

Title	Effects of Oral Ingestion of Sunphenon 90 DCF-T on Histologic Findings in Prostate Tissue Such as Nuclear Measurements Viz. Shape, Size and Texture
Description	Effects of oral ingestion of Sunphenon 90 DCF-T on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

Could not be determined because there were no tumor cells in biopsy

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	0	0

13. Secondary Outcome

Title	Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Description	Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
Urinary Incontinence	2.33 (2.18)	3.0 (2.65)
Urinary Irritation	0.54 (0.66)	1.5 (1.37)
Bowel Function	0.21 (0.41)	0.16 (0.41)
Sexual Function	3.04 (1.36)	4.16 (1.60)
Hormonal Function	0.05 (0.22)	0.0 (0.0)

14. Secondary Outcome

Title	Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Description	Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
Time Frame	At 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
Urinary Incontinence	2.66 (2.14)	3.0 (2.65)
Urinary Irritation	0.46 (0.66)	1.5 (1.64)
Bowel Function	0.16 (0.38)	0.33 (0.51)
Sexual Function	3.12 (1.15)	4.16 (1.60)
Hormonal Function	0.05 (0.22)	0.0 (0.0)

15. Secondary Outcome

Title	Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Description	Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
Time Frame	at 3.5 years from start of study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
Urinary Incontinence	2.41 (1.97)	3.0 (2.65)
Urinary Irritation	1.08 (1.35)	1.33 (1.50)
Bowel Function	0.54 (0.83)	0.16 (0.41)
Sexual Function	3.08 (1.21)	3.83 (1.47)
Hormonal Function	0.10 (0.30)	0.0 (0.0)

16. Secondary Outcome

Title	Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Description	Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
PCS	52.78 (4.07)	55.89 (0.0)
MCS	56.79 (1.18)	52.98 (0.0)

17. Secondary Outcome

Title	Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Description	Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
Time Frame	At 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
PCS	53.48 (4.82)	55.89 (0.0)
MCS	55.78 (5.38)	52.98 (0.0)

18. Secondary Outcome

Title	Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Description	Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
Time Frame	At 3.5 years from start of study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
PCS	53.53 (4.54)	57.23 (0.0)
MCS	56.04 (1.09)	55.92 (0.0)

19. Secondary Outcome

Title	Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Description	Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
Mean (Standard Deviation) [score on a scale]	3.5 (3.1)	21 (0.0)

20. Secondary Outcome

Title	Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Description	Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.
Time Frame	At 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
Mean (Standard Deviation) [score on a scale]	5.75 (2.87)	19.0 (0.0)

21. Secondary Outcome

Title	Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Description	Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.
Time Frame	At 3.5 years from start of study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	4	1
Mean (Standard Deviation) [score on a scale]	9.5 (11.26)	19.0 (0.0)

22. Secondary Outcome

Title	Sexual Health Inventory in Men Score (SHIM Score)
Description	SHIM score - The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows: 22 - 25: No significant erectile dysfunction 17 - 21: Mild erectile dysfunction 12 - 16: Mild-to-moderate erectile dysfunction 8 - 11: Moderate erectile dysfunction 5 - 7: Severe erectile dysfunction Reported values are an average of three collected data points per participant: at baseline, at 24 weeks, and at end of study (3.5 years)
Time Frame	Baseline, at 24 weeks, and at 3.5 years from start of study

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Arm A (Active Surveillance)	Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
Measure Participants	0	0

Adverse Events

Time Frame	30 days after treatment
Arm/Group Title	Arm A (Active Surveillance)		Arm B (Sunphenon)
Arm/Group Description	Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies		Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies
All Cause Mortality
	Arm A (Active Surveillance)		Arm B (Sunphenon)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/2 (0%)
Serious Adverse Events
	Arm A (Active Surveillance)		Arm B (Sunphenon)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Arm A (Active Surveillance)		Arm B (Sunphenon)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/4 (50%)		1/2 (50%)
Ear and labyrinth disorders
Vertigo	1/4 (25%)	1	0/2 (0%)	0
Musculoskeletal and connective tissue disorders
Back Pain	0/4 (0%)	0	1/2 (50%)	3
Psychiatric disorders
Anxiety	1/4 (25%)	1	0/2 (0%)	0
Renal and urinary disorders
Dysuria	2/4 (50%)	2	0/2 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.