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NCT Number: NCT01912820

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

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.

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Key information

Conditions

Adenocarcinoma of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer Urogenital Diseases Urogenital Neoplasms

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green Tea Extract

Dietary Supplement

Given PO

Other names: green tea polyphenols

Quercetin

Drug

Given PO

Other names: C.I. natural yellow 10

Placebo

Other

Given PO

Other names: PLCB

therapeutic conventional surgery

Procedure

Undergo prostatectomy

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Green tea polyphenols, quercetin and their metabolite concentration in blood and prostate tissue

    Time frame: On the day of surgery

    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.

Secondary outcomes

  1. Protein and gene expression of COMT in prostate tissue

    Time frame: Day of surgery

  2. Protein and gene expression of DNMT1 in prostate tissue

    Time frame: Day of surgery

  3. Protein and gene expression of MRP1 in prostate tissue

    Time frame: Day of surgery

  4. COMT activity in red blood cells

    Time frame: Week 3

  5. Genotype of COMT (high [H]/H, low [L]/L or H/L)

    Time frame: Week 3

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

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2021
First posted
Jul 31, 2013
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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