Green Tea or Water in Treating Patients With Prostate Cancer Undergoing Surgery
This trial is active, not recruiting.
|Treatments||green tea, placebo|
|Sponsor||Jonsson Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||September 2007|
|End date||April 2017|
|Trial size||160 participants|
|Trial identifier||NCT00685516, CDR0000596162, P30CA016042, R01CA116242, UCLA-061109702|
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 water in treating prostate cancer.
PURPOSE: This randomized phase II trial is studying green tea to see how well it works compared with water in treating patients with prostate cancer undergoing surgery.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||parallel assignment|
Biomarkers of prostate cancer development and progression
time frame: 6 weeks
Concentration of tea polyphenols, their metabolites, and colonic metabolites in prostate tissue, serum, and urine
time frame: 6 weeks
Male participants from 40 years up to 75 years old.
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
|Official title||A Phase II Randomized, Open-Label, Two-Arm Study of Green Tea and a Water Control in Men Scheduled for Prostatectomy|
|Principal investigator||Susanne M. Henning, PhD, RD|
|Description||OBJECTIVES: - To determine the effects of drinking 6 cups of green tea vs water for an average of 6 weeks prior to prostatectomy on prostate tumor grade and stage (i.e., biopsy and prostatectomy specimen), margin status of prostatectomy specimen, biomarkers of prostate cancer development and progression (i.e., serum prostate-specific antigen [PSA], proliferation [Ki-67], apoptosis [TUNEL, Bax/Bcl-2 ratio], inflammation [NFkB], and oxidative status [8OhdG/dG ratio]) in patients with adenocarcinoma of the prostate. - To compare changes in prostate tissue biomarkers (prostate biopsy tissue vs corresponding radical prostatectomy tissue). - To determine the concentrations of total and free tea polyphenols (i.e., EGCG, EC, EGC, ECG) and theaflavins, as well as 4'-O-methyl-epigallocatechin gallate (4'-O-MeEGC), EGCG-4'-O-glucuronide, EGCG-4"-O-glucuronide, 3M4HPAA, 4HPAA, and 3,4DHPAA in human serum, urine, and prostate tissue after green tea, black tea, and water consumption. - To determine the subject's genotype of catechol-O-methyltransferase (COMT), UDPglucuronosyltransferases (UGT1A1) and sulfotransferase (SULT1A1), and the effect of the intervention on gene expression of COMT, UGTs, and SULTs in prostate tissue. - To determine the antiproliferative effect on human serum before and after tea supplementation in an ex vivo LNCaP cell culture assay and to investigate the mechanism of the antiproliferative activity. - To determine the effect of tea supplementation on serum IGF-1, IGFBP-3, testosterone, SHBG, and DHEA-sulfate. OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 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. 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.|
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