To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring
Launched by ECOG-ACRIN CANCER RESEARCH GROUP · Oct 20, 2020
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether green tea catechins, which are natural compounds found in green tea, can help slow down the progression of prostate cancer in men who are being closely monitored. The study specifically focuses on men with low-risk prostate cancer who are on a watchful waiting plan called active surveillance. The goal is to see if drinking green tea can stabilize their condition and reduce the chances of cancer worsening.
To participate in this trial, men need to have been diagnosed with prostate cancer confirmed by a biopsy and be categorized as very low, low, or favorable intermediate risk. Participants should be willing to limit their green tea intake and will need to undergo follow-up biopsies during the study. This trial is currently recruiting eligible participants aged between 70 and 76 years old. It’s important to note that those who have received prior treatment for prostate cancer or have certain health conditions may not qualify. Participants can expect to either receive the green tea catechins or a placebo (a treatment with no active ingredients) while being monitored for changes in their cancer status.
Gender
ALL
Eligibility criteria
- 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
About Ecog Acrin Cancer Research Group
The ECOG-ACRIN Cancer Research Group is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative clinical trials and rigorous scientific inquiry. As a collaborative network of researchers, healthcare professionals, and institutions, ECOG-ACRIN focuses on improving cancer treatment and patient outcomes by conducting high-quality, multicenter studies. Their research spans various cancer types and includes a wide array of therapeutic approaches, emphasizing the integration of cutting-edge methodologies and patient-centered care. Committed to fostering collaboration and sharing knowledge, ECOG-ACRIN plays a vital role in transforming cancer care and enhancing the understanding of cancer biology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charleston, South Carolina, United States
Jamaica, New York, United States
Flint, Michigan, United States
Denver, Colorado, United States
Denver, Colorado, United States
Flint, Michigan, United States
Burnsville, Minnesota, United States
Edina, Minnesota, United States
Waconia, Minnesota, United States
Harvey, Illinois, United States
Peoria, Illinois, United States
Hackensack, New Jersey, United States
Oklahoma City, Oklahoma, United States
Des Moines, Iowa, United States
Elmhurst, New York, United States
Saint Paul, Minnesota, United States
New Brunswick, New Jersey, United States
Cincinnati, Ohio, United States
Oakland, California, United States
Fort Collins, Colorado, United States
Mount Vernon, Illinois, United States
Coon Rapids, Minnesota, United States
Urbana, Illinois, United States
Carroll, Iowa, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Shakopee, Minnesota, United States
Willmar, Minnesota, United States
Council Bluffs, Iowa, United States
Dayton, Ohio, United States
Effingham, Illinois, United States
Saint Joseph, Missouri, United States
Greenville, Ohio, United States
Bethlehem, Pennsylvania, United States
Fayetteville, Arkansas, United States
Longmont, Colorado, United States
Springfield, Illinois, United States
Fairfax, Virginia, United States
Cincinnati, Ohio, United States
Springfield, Illinois, United States
San Antonio, Texas, United States
Honolulu, Hawaii, United States
Minneapolis, Minnesota, United States
Philadelphia, Pennsylvania, United States
Aurora, Colorado, United States
Aurora, Colorado, United States
Honolulu, Hawaii, United States
Saint Louis, Missouri, United States
Kearney, Nebraska, United States
Chapel Hill, North Carolina, United States
Aurora, Illinois, United States
Kettering, Ohio, United States
Allentown, Pennsylvania, United States
Federal Way, Washington, United States
Lakewood, Washington, United States
Falls Church, Virginia, United States
Cape Girardeau, Missouri, United States
Aventura, Florida, United States
Oakland, California, United States
Martinez, California, United States
Honolulu, Hawaii, United States
Washington, District Of Columbia, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Pueblo, Colorado, United States
Fridley, Minnesota, United States
Robbinsdale, Minnesota, United States
Saint Louis Park, Minnesota, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Portland, Oregon, United States
San Juan, , Puerto Rico
Omaha, Nebraska, United States
Portland, Oregon, United States
Fort Lauderdale, Florida, United States
Albuquerque, New Mexico, United States
Richmond, Virginia, United States
Detroit, Michigan, United States
Saint Louis, Missouri, United States
Green Bay, Wisconsin, United States
Honolulu, Hawaii, United States
Miami Beach, Florida, United States
Decatur, Illinois, United States
Ottawa, Illinois, United States
Peoria, Illinois, United States
Galesburg, Illinois, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Lansing, Michigan, United States
Warren, Michigan, United States
Lincoln, Nebraska, United States
Papillion, Nebraska, United States
Omaha, Nebraska, United States
Cape Girardeau, Missouri, United States
Peru, Illinois, United States
Des Moines, Iowa, United States
Adrian, Michigan, United States
Monroe, Michigan, United States
Pontiac, Michigan, United States
Maplewood, Minnesota, United States
Maplewood, Minnesota, United States
Stillwater, Minnesota, United States
Findlay, Ohio, United States
Maumee, Ohio, United States
Toledo, Ohio, United States
Bremerton, Washington, United States
Alexandria, Virginia, United States
'Aiea, Hawaii, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Alton, Illinois, United States
Galesburg, Illinois, United States
Richmond, Indiana, United States
Ames, Iowa, United States
Saginaw, Michigan, United States
Woodbury, Minnesota, United States
Joplin, Missouri, United States
Springfield, Missouri, United States
Springfield, Missouri, United States
Boardman, Ohio, United States
Dayton, Ohio, United States
Franklin, Ohio, United States
Toledo, Ohio, United States
Troy, Ohio, United States
Warren, Ohio, United States
Youngstown, Ohio, United States
East Stroudsburg, Pennsylvania, United States
West Reading, Pennsylvania, United States
Green Bay, Wisconsin, United States
Kettering, Ohio, United States
Emeryville, California, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Chicago, Illinois, United States
Concord, New Hampshire, United States
Springfield, Ohio, United States
Aurora, Colorado, United States
Livonia, Michigan, United States
San Antonio, Texas, United States
Kailua, Hawaii, United States
Littleton, Colorado, United States
New Ulm, Minnesota, United States
Albuquerque, New Mexico, United States
Denver, Colorado, United States
Denver, Colorado, United States
Louisville, Kentucky, United States
Canton, Illinois, United States
Carthage, Illinois, United States
Eureka, Illinois, United States
Kewanee, Illinois, United States
Macomb, Illinois, United States
Peru, Illinois, United States
Princeton, Illinois, United States
Parker, Colorado, United States
La Jolla, California, United States
Joplin, Missouri, United States
Ft. Smith, Arkansas, United States
San Diego, California, United States
Grand Island, Nebraska, United States
Fort Smith, Arkansas, United States
Bloomington, Illinois, United States
Pekin, Illinois, United States
Bolivar, Missouri, United States
Branson, Missouri, United States
Saint Louis, Missouri, United States
Manchester, New Hampshire, United States
San Juan, , Puerto Rico
Carmichael, California, United States
Fairbanks, Alaska, United States
Hot Springs, Arkansas, United States
Jefferson City, Missouri, United States
Omaha, Nebraska, United States
Oklahoma City, Oklahoma, United States
Bryan, Texas, United States
Emeryville, California, United States
Merced, California, United States
Honolulu, Hawaii, United States
Lihue, Hawaii, United States
West Des Moines, Iowa, United States
Rolla, Missouri, United States
Rolla, Missouri, United States
Martinsville, Virginia, United States
Burien, Washington, United States
New Richmond, Wisconsin, United States
Urbana, Illinois, United States
Rogers, Arkansas, United States
Springfield, Illinois, United States
Longmont, Colorado, United States
Springfield, Ohio, United States
West Columbia, South Carolina, United States
Fairfax, Virginia, United States
Loveland, Colorado, United States
Clive, Iowa, United States
West Des Moines, Iowa, United States
Garden City, Kansas, United States
Great Bend, Kansas, United States
Brighton, Michigan, United States
Canton, Michigan, United States
Caro, Michigan, United States
Chelsea, Michigan, United States
Clarkston, Michigan, United States
Clarkston, Michigan, United States
East China Township, Michigan, United States
Flint, Michigan, United States
Flint, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Livonia, Michigan, United States
Macomb, Michigan, United States
Macomb, Michigan, United States
Marlette, Michigan, United States
Pontiac, Michigan, United States
Pontiac, Michigan, United States
Pontiac, Michigan, United States
Saginaw, Michigan, United States
Sterling Heights, Michigan, United States
Warren, Michigan, United States
Warren, Michigan, United States
Warren, Michigan, United States
Warren, Michigan, United States
West Branch, Michigan, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
Centerville, Ohio, United States
Colorado Springs, Colorado, United States
Durango, Colorado, United States
Durango, Colorado, United States
Lakewood, Colorado, United States
Thornton, Colorado, United States
Creston, Iowa, United States
Bardstown, Kentucky, United States
Corbin, Kentucky, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Shepherdsville, Kentucky, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Enumclaw, Washington, United States
Tacoma, Washington, United States
Boulder, Colorado, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Littleton, Colorado, United States
Lone Tree, Colorado, United States
Carbondale, Illinois, United States
Carterville, Illinois, United States
Centralia, Illinois, United States
Danville, Illinois, United States
Decatur, Illinois, United States
Effingham, Illinois, United States
Mattoon, Illinois, United States
O'fallon, Illinois, United States
Yorkville, Illinois, United States
Louisville, Kentucky, United States
Brighton, Michigan, United States
Canton, Michigan, United States
Chelsea, Michigan, United States
Ypsilanti, Michigan, United States
Maple Grove, Minnesota, United States
Wyoming, Minnesota, United States
Sainte Genevieve, Missouri, United States
Sullivan, Missouri, United States
Sunset Hills, Missouri, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Findlay, Ohio, United States
Findlay, Ohio, United States
Franklin, Ohio, United States
Greenville, Ohio, United States
Troy, Ohio, United States
Cheyenne, Wyoming, United States
Dublin, California, United States
Ames, Iowa, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Richmond, Virginia, United States
Walnut Creek, California, United States
Monticello, Minnesota, United States
Bronx, New York, United States
Honolulu, Hawaii, United States
London, Kentucky, United States
Port Townsend, Washington, United States
'Aiea, Hawaii, United States
'Aiea, Hawaii, United States
Des Moines, Iowa, United States
Aiea, Hawaii, United States
Phoenix, Arizona, United States
Elk Grove, California, United States
Rocklin, California, United States
Sacramento, California, United States
San Luis Obispo, California, United States
Santa Maria, California, United States
Woodland, California, United States
Boulder, Colorado, United States
Tawas City, Michigan, United States
Bayamon, , Puerto Rico
Beavercreek, Ohio, United States
Bayamon, , Puerto Rico
Manati, , Puerto Rico
Springdale, Arkansas, United States
Arroyo Grande, California, United States
Hazleton, Pennsylvania, United States
Honolulu, Hawaii, United States
Ballwin, Missouri, United States
Washington, Missouri, United States
Denver, Colorado, United States
Fort Dodge, Iowa, United States
Chesapeake, Virginia, United States
'Aiea, Hawaii, United States
Springfield, Ohio, United States
Centennial, Colorado, United States
Englewood, Colorado, United States
Dixon, Illinois, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Colorado Springs, Colorado, United States
Englewood, Colorado, United States
Fort Collins, Colorado, United States
Greeley, Colorado, United States
Burnsville, Minnesota, United States
San Juan, , Puerto Rico
San Mateo, California, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
Carmichael, California, United States
'Aiea, Hawaii, United States
'Ewa Beach, Hawaii, United States
Honolulu, Hawaii, United States
Kahului, Hawaii, United States
Tamuning, , Guam
Highlands Ranch, Colorado, United States
Charleston, South Carolina, United States
Little Rock, Arkansas, United States
'Aiea, Hawaii, United States
Grand Island, Nebraska, United States
Denver, Colorado, United States
Lexington, Kentucky, United States
Aurora, Colorado, United States
South Portland, Maine, United States
Des Moines, Iowa, United States
Encinitas, California, United States
Mount Sterling, Kentucky, United States
Cameron Park, California, United States
Troy, Ohio, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Centralia, Illinois, United States
Nags Head, North Carolina, United States
Paducah, Kentucky, United States
San Juan, , Puerto Rico
Danville, Illinois, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Ames, Iowa, United States
Merced, California, United States
Canton, Michigan, United States
Osage Beach, Missouri, United States
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
O'fallon, Illinois, United States
Des Moines, Iowa, United States
Clive, Iowa, United States
Lansing, Michigan, United States
Carmichael, California, United States
Placerville, California, United States
Jefferson City, Missouri, United States
Pontiac, Michigan, United States
Martinsville, Virginia, United States
Silverdale, Washington, United States
Dayton, Ohio, United States
Walnut Creek, California, United States
East China, Michigan, United States
Macomb Township, Michigan, United States
Macomb Township, Michigan, United States
Aiea, Hawaii, United States
Aiea, Hawaii, United States
Aiea, Hawaii, United States
Ewa Beach, Hawaii, United States
Aiea, Hawaii, United States
Patients applied
Trial Officials
Nagi B Kumar
Principal Investigator
ECOG-ACRIN Cancer Research Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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