Status:
COMPLETED
Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Eligibility:
MALE
40-75 years
Phase:
PHASE1
Brief Summary
This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical prostatectomy....
Detailed Description
PRIMARY OBJECTIVES: I. To investigate the prostate tissue concentration of epigallocatechin gallate (EGCG), epicatechin gallate (ECG) and quercetin and their methylated metabolites in men scheduled f...
Eligibility Criteria
Inclusion
- Subjects consent to participate in the trial
- The subject has a diagnosis of adenocarcinoma of the prostate
- The subject is scheduled to undergo radical prostatectomy
- The subject agrees to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention
Exclusion
- 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 and quercetin supplements
- Allergies to multiple food items or nutritional supplements
- Taking luteinizing hormone-releasing hormone (LHRH) agonists, androgen receptor blocking agents, finasteride, or has undergone bilateral orchiectomy
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01912820
Start Date
January 1 2014
End Date
June 10 2021
Last Update
June 23 2021
Active Locations (2)
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1
Veterans Administration Los Angeles Healthcare System
Los Angeles, California, United States, 90073
2
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095