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ACTIVE NOT RECRUITING

NCT04597359

PHASE2

To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring

Sponsor: ECOG-ACRIN Cancer Research Group

View on ClinicalTrials.gov

Summary

This phase II trial studies how well green tea catechins work in preventing progression of prostate cancer from a low risk stage to higher risk stages in men who are on active surveillance. Green tea catechins may stabilize prostate cancer and lower the chance of prostate growing.

Official title: A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2021-10-05

Completion Date

2032-12-31

Last Updated

2026-03-23

Healthy Volunteers

Conditions

Prostate Carcinoma

Interventions

DRUG

Placebo Administration

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Sinecatechins

Given PO

Inclusion Criteria: * INCLUSION CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING) * Patient must have biopsy-proven (consisting of \>= 12 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core in the most recent biopsy using initial transrectal ultrasound (TRUS) biopsy or TRUS biopsy followed by multiparametric magnetic resonance imaging (mpMRI) of the prostate and a confirmatory targeted biopsy * Patient must be on active surveillance (very low, low and favorable intermediate risk as defined by the National Comprehensive Cancer Network \[NCCN\]) * Patient must be scheduled for a follow up prostate biopsy 6 months after the initiation of treatment on this study * Patient must have a serum PSA \< 10 ng/mL or prostate specific antigen density (PSAD) \< 0.15 ng/mL/ g obtained within 30 days of registration * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patient must be willing to abstain from consumption of any supplements containing green tea catechins * Patient must be willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week (serving size of 8 oz) * Patient must be willing to discontinue current vitamin/mineral supplement use and use one provided by study * Patient must be willing to take study agent or placebo at the dose specified with meals * Patient must have the ability to understand and the willingness to sign a written informed consent document * Absolute neutrophil count \>= 1,200/mm\^3 (\>= 1.2 k/uL) (obtained within 30 days prior to registration) * Platelets \>= 75,000/mm\^3 (\>= 75 k/uL) (obtained within 30 days prior to registration) * Total bilirubin =\< 1.2 mg/dL (or =\< 3.0 mg/dL for patients with Gilbert's syndrome) (obtained within 30 days prior to registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x upper limit of normal (ULN) (obtained within 30 days prior to registration) * Serum creatinine =\< 1.5 x ULN (obtained within 30 days prior to registration) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Sexually active males must use an accepted and effective method of double barrier contraception (vasectomy must be combined with a physical barrier method) or abstain from sexual intercourse for the duration of their participation in the study * Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen available for Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue for eligibility and stratification. Tumor tissue can be submitted any time during screening * Tumor tissue specimen has been collected and is ready to ship to H. Lee Moffitt Cancer Center \& Research Institute * H. Lee Moffitt Cancer Center \& Research Institute will perform Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue and notify the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Operations Office and submitting institution within 3-4 business days of receipt of the tumor tissue specimen * INCLUSION CRITERIA FOR RANDOMIZATION (STEP 1) * Patient must meet all Step 0 eligibility criteria at the time of their registration to Step 1 * Patient must have Gleason score (3+3) or predominant Gleason pattern 3 (3+4), =\< 33% of biopsy cores, and =\< 50% involvement of any biopsy core * Patient must have % Ki-67 expression of 5% or more in tumor tissue Exclusion Criteria: * EXCLUSION CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING) * Patient must not have had prior treatment for prostate cancer, including focal therapy, with surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen deprivation therapy * Patient must not have a history of renal or hepatic disease, including history of hepatitis B and C * Patient must not have prostate cancer with distant metastases * Patient must not have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patient must not receive any other investigational agents while on this study * Patient must not have a history of allergic reactions attributed to tea or other compounds of similar chemical or biologic composition to green tea extracts

Locations (353)

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

CARTI Cancer Center

Little Rock, Arkansas, United States

Highlands Oncology Group - Rogers

Rogers, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Marshall Cancer Center

Cameron Park, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Epic Care-Dublin

Dublin, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

UC San Diego Health System - Encinitas

Encinitas, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Mercy Cancer Center

Merced, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Marshall Hospital

Placerville, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

UCSF Cancer Center - San Mateo

San Mateo, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

BASS Medical Group - Lennon

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

UCHealth - Cherry Creek

Denver, Colorado, United States

The Women's Imaging Center

Denver, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Mercy Medical Center

Durango, Colorado, United States

Southwest Oncology PC

Durango, Colorado, United States

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

The Melanoma and Skin Cancer Institute

Englewood, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Littleton Adventist Hospital

Littleton, Colorado, United States

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Parker Adventist Hospital

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Hawaii Cancer Care Inc - Waterfront Plaza