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

NCT01912820 | Completed Phase 1 DMC

• 3 other identifiers: 12-000886NCI-2013-01153R03CA171583
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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. 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.

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  On the day of surgery

Secondary Outcomes (5)

• Protein and gene expression of COMT in prostate tissue

  Day of surgery

• Protein and gene expression of DNMT1 in prostate tissue

  Day of surgery

• Protein and gene expression of MRP1 in prostate tissue

  Day of surgery

• COMT activity in red blood cells

  Week 3

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

  Week 3

Study Arms (2)

Arm I (quercetin, green tea extract)

EXPERIMENTAL

Patients receive GT extract PO BID and quercetin PO BID for 3-6 weeks before undergoing prostatectomy.

Dietary Supplement: green tea extract; Drug: quercetin; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis

Arm II (GT extract, placebo)

PLACEBO COMPARATOR

Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.

Dietary Supplement: green tea extract; Other: placebo; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis

Interventions

green tea extract DIETARY_SUPPLEMENT

Given PO

Also known as: green tea polyphenols

Arm I (quercetin, green tea extract); Arm II (GT extract, placebo)

quercetin DRUG

Given PO

Also known as: C.I. natural yellow 10

Arm I (quercetin, green tea extract)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (GT extract, placebo)

therapeutic conventional surgery PROCEDURE

Undergo prostatectomy

Arm I (quercetin, green tea extract); Arm II (GT extract, placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (quercetin, green tea extract); Arm II (GT extract, placebo)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Veterans Administration Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Tea; Quercetin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Susanne Henning, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: July 31, 2013
• Study Start: January 1, 2014
• Primary Completion: January 31, 2016
• Study Completion: June 10, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

US (2)