Overview

This trial is active, not recruiting.

Conditions 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
Treatments green tea extract, quercetin, placebo, therapeutic conventional surgery, laboratory biomarker analysis
Phase phase 1
Sponsor Jonsson Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date January 2014
End date September 2017
Trial size 31 participants
Trial identifier NCT01912820, 12-000886, NCI-2013-01153, P30CA016042, R03CA171583

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. Side effects of green tea extract and quercetin in combination with green tea extract will also be evaluated. In preclinical studies, green tea polyphenols have anticancer and cancer preventative effects in a number of malignancies. Likewise, in preclinical studies quercetin was found to enhance the anticancer effects of green tea. This trial is designed to translate these findings forward in a short-term human intervention trial.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Patients receive GT extract PO BID and quercetin PO BID for 3-6 weeks before undergoing prostatectomy.
green tea extract green tea polyphenols
Given PO
quercetin C.I. natural yellow 10
Given PO
therapeutic conventional surgery
Undergo prostatectomy
laboratory biomarker analysis
Correlative studies
(Placebo Comparator)
Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.
green tea extract green tea polyphenols
Given PO
placebo PLCB
Given PO
therapeutic conventional surgery
Undergo prostatectomy
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Green tea polyphenols, quercetin and their metabolite concentration in blood and prostate tissue
time frame: On the day of surgery

Secondary Outcomes

Measure
Protein and gene expression of COMT in prostate tissue
time frame: Day of surgery
Protein and gene expression of DNMT1 in prostate tissue
time frame: Day of surgery
Protein and gene expression of MRP1 in prostate tissue
time frame: Day of surgery
COMT activity in red blood cells
time frame: Week 3
Genotype of COMT (high [H]/H, low [L]/L or H/L)
time frame: Week 3

Eligibility Criteria

Male participants from 40 years up to 75 years old.

Inclusion Criteria: - 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 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 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

Additional Information

Official title 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
Principal investigator Susanne Henning
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 for prostatectomy and consuming green tea (GT)extract (N=15) or GTextract with quercetin (N=15) for 3 weeks prior to prostatectomy. II. To determine the concentration of EGCG, ECG, epigallocatechin (EGC), epicatechin (EC) and quercetin and the methylated metabolites in plasma collected before (T=0) and two hours (T=2) after the intake of the morning dose of GTextract and placebo or GTextract with quercetin during the third week of intervention. III. To determine the effect of GTextract/quercetin intervention on reducing the enzyme activity and protein and gene expression of catechol-O-methyltransferase (COMT) and deoxyribonucleic (DNA) (cytosine-5) methyltransferase 1 (DNMT1) as well as protein and gene expression of multidrug resistance transport protein 1 (MRP1) in prostate tissue collected in specific aim 1 and COMT activity in erythrocytes from blood collected at baseline and week 3. IV. To determine the inter-individual variation in genotype of COMT in buffy coat DNA. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive GT extract orally (PO) twice daily (BID) and quercetin PO BID for 3-6 weeks before undergoing prostatectomy. ARM II: Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center.
Location data was received from the National Cancer Institute and was last updated in May 2016.