Green Tea or Water in Treating Patients With Prostate Cancer Undergoing Surgery
This study is ongoing, but not recruiting participants.
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00685516
First received: May 22, 2008
Last updated: October 5, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: green tea Dietary Supplement: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Randomized, Open-Label, Two-Arm Study of Green Tea and a Water Control in Men Scheduled for Prostatectomy |
Resource links provided by NLM:
Further study details as provided by Jonsson Comprehensive Cancer Center:
Primary Outcome Measures:
- Biomarkers of prostate cancer development and progression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Concentration of tea polyphenols, their metabolites, and colonic metabolites in prostate tissue, serum, and urine [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Dietary Supplement: green tea
6 cups of green tea daily for 2-8 weeks
|
|
Placebo Comparator: Arm II
Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Dietary Supplement: placebo
6 cups of water daily for 2-8 weeks
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685516
Locations
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Veterans Affairs Medical Center - West Los Angeles | |
| Los Angeles, California, United States, 90073 | |
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
| Principal Investigator: | Susanne M. Henning, PhD, RD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00685516 History of Changes |
| Other Study ID Numbers: | CDR0000596162, R01CA116242, P30CA016042, UCLA-061109702 |
| Study First Received: | May 22, 2008 |
| Last Updated: | October 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer |
stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013