Patients receive GT extract PO BID and quercetin PO BID for 3-6 weeks before undergoing prostatectomy.

Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.

Adenocarcinoma of the Prostate

Recurrent Prostate Cancer

Stage I Prostate Cancer

Stage IIA Prostate Cancer

Stage IIB Prostate Cancer

Stage III Prostate Cancer

Stage IV Prostate Cancer

green tea extract

quercetin

placebo

therapeutic conventional surgery

laboratory biomarker analysis

Veterans Administration Los Angeles Healthcare System

Jonsson Comprehensive Cancer Center

Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery

A Phase I Randomized, Double-Blind, Placebo-Controlled Two-Arm Study of Quercetin and Green Tea to Enhance the Bioavailability of Green Tea Polyphenols in Men Scheduled for Prostatectomy

Means and standard deviation will be calculated and the statistical difference between treatment with GTextract + quercetin compared to GTextract + placebo will be determined using Student's t-test computed by one-way analysis of variance models.

Gene-association analyses will be conducted for COMT polymorphic variants within each intervention group using SAS Genetics, version 9.1

National Cancer Institute (NCI)

Incident Breast Cancer

tea capsule

USC/Norris Comprehensive Cancer Center

Green Tea in Breast Cancer Patients

Green Tea Supplement in Women With Incident Breast Cancer

University of Southern California

Coltect contains natural compounds: curcumin, green tea and selenium which are approved as food supplements by the Ministry of Health in Israel. Curcumin and green tea are widely used in the food industry.

Ulcerative Colitis

Two tablets twice daily (BID) during the 2 months of the study. Each tablet contains 500mg Curcumin, 250mg Green tea and 100mcg Selenomethionine.

Coltect

Tel-Aviv Sourasky Medical Center

The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label

Dr. Iris Dotan

Patients receive six oral placebo capsules once daily for 14-28 days.

Patients receive four oral polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.

Patients receive six oral polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies

Arm I (Placebo)

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies

Arm II (800mg Polyphenon E, Placebo)

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies

Arm III (1200mg Polyphenon E)

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Comparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.

Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors)

Levels of EGCG in Malignant Bladder Tissue

Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry

Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA

Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples

The difference between the amount at the end of study (up to 28 days) from baseline.

Absolute Change for Baseline From EGCG in Serum Samples

Glycine/Glycine

Alanine/Glycine

Alanine/Alanine

Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT)

Serum IGFBP-3 Levels Assessed by ELISA

Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples

Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples

Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples

Absolute Change for Baseline of EGCG in Urine Samples

5/6 Genotype

6/6 Genotype

6/7 Genotype

7/7 Genotype

Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT)

Overall Study

Howard H. Bailey

Stage I Bladder Cancer

Stage II Bladder Cancer

Stage III Bladder Cancer

Defined Green Tea Catechin Extract

Laboratory Biomarker Analysis

Pharmacological Study

Placebo

Therapeutic Conventional Surgery

University of Alabama at Birmingham Cancer Center

Lahey Hospital and Medical Center

Minneapolis Veterans Medical Center

University of Rochester

Urology San Antonio Research PA

University of Wisconsin Hospital and Clinics

Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer

A Phase II Randomized, Placebo-Controlled Trial of Polyphenon E to Evaluate Bladder Tissue Levels of EGCG