Prostate Cancer

EA8184



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

STATUS: Active


This phase II trial studies whether green tea catechins can prevent 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 growth.
  • INCLUSION CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING)

  • Patient must be >= 21 years of age

  • Patient must speak English or Spanish

  • 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 multiparametric magnetic resonance imaging (mpMRI)-Prostate or transperineal (TP) Biopsy or transrectal ultrasound (TRUS) Biopsy

  • Patient must be on active surveillance (local - Gleason 3+3 or Gleason 3+4 [very low, low and favorable intermediate risk] as defined by the National Comprehensive Cancer Network [NCCN])

  • Patientโ€™s baseline biopsy must have occurred at least 6 months but not more than 18 months prior to preregistration to step 0. NOTE: Patient is to 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 preregistration

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0โˆ’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 if it contains green tea products 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 Gilbertโ€™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

  • 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

  • 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 confirmed via central review

  • Patient must have % Ki-67 expression of 5% or more in at least 1 core positive for tumor tissue confirmed via central review

United States
AR
Fayetteville
Highlands Oncology Group - Fayetteville
Contact: Site Public Contact
Email: research@hogonc.com

Ft. Smith
Mercy Hospital Fort Smith
Contact: Site Public Contact

Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Rogers
Highlands Oncology Group - Rogers
Contact: Site Public Contact
Email: research@hogonc.com

Springdale
Highlands Oncology Group
Contact: Site Public Contact
Email: research@hogonc.com

AZ
Phoenix
Cancer Center at Saint Joseph's
Contact: Site Public Contact
Email: CancerInstitute@DignityHealth.org

CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Carmichael
Mercy San Juan Medical Center
Contact: Site Public Contact
Email: OncologyResearch@DignityHealth.org

Dublin
Epic Care-Dublin
Contact: Site Public Contact

Emeryville
Bay Area Breast Surgeons Inc
Contact: Site Public Contact

Epic Care Partners in Cancer Care
Contact: Site Public Contact

Martinez
Contra Costa Regional Medical Center
Contact: Site Public Contact

Oakland
Alta Bates Summit Medical Center - Summit Campus
Contact: Site Public Contact

Bay Area Tumor Institute
Contact: Site Public Contact
Email: lradke@bati.org

Rocklin
Mercy Cancer Center - Rocklin
Contact: Site Public Contact
Email: OncologyResearch@DignityHealth.org

Sacramento
Mercy Cancer Center - Sacramento
Contact: Site Public Contact
Email: OncologyResearch@DignityHealth.org

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

San Mateo
UCSF Cancer Center - San Mateo
Contact: Site Public Contact
Email: cancertrials@ucsf.edu

Santa Maria
Mission Hope Medical Oncology - Santa Maria
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Walnut Creek
Epic Care Cyberknife Center
Contact: Site Public Contact
Email: somega@bati.org

Woodland
Woodland Memorial Hospital
Contact: Site Public Contact
Email: OncologyResearch@DignityHealth.org

CO
Aurora
University of Colorado Hospital
Contact: Site Public Contact

Colorado Springs
Penrose-Saint Francis Healthcare
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Penrose
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Saint Francis Cancer Center
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Denver
Porter Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

UCHealth - Cherry Creek
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Durango
Mercy Medical Center
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Southwest Oncology PC
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Fort Collins
Cancer Care and Hematology-Fort Collins
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Poudre Valley Hospital
Contact: Site Public Contact

Greeley
UCHealth Greeley Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Highlands Ranch
UCHealth Highlands Ranch Hospital
Contact: Site Public Contact

Lakewood
Saint Anthony Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Littleton
Littleton Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Longmont
Longmont United Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Longmont
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Loveland
Medical Center of the Rockies
Contact: Site Public Contact

Parker
Parker Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Pueblo
Saint Mary Corwin Medical Center
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

DC
Washington
MedStar Washington Hospital Center
Contact: Site Public Contact

FL
Aventura
Mount Sinai Comprehensive Cancer Center at Aventura
Contact: Site Public Contact
Email: yenrique@msmc.com

Fort Lauderdale
Holy Cross Hospital
Contact: Site Public Contact

Miami Beach
Mount Sinai Medical Center
Contact: Site Public Contact
Email: yenrique@msmc.com

GU
Tamuning
FHP Health Center-Guam
Contact: Site Public Contact

HI
Aiea
Hawaii Cancer Care - Savio
Contact: Site Public Contact
Email: info@hawaiicancercare.com

Pali Momi Medical Center
Contact: Site Public Contact

Queen's Cancer Center - Pearlridge
Contact: Site Public Contact

Straub Pearlridge Clinic
Contact: Site Public Contact

The Cancer Center of Hawaii-Pali Momi
Contact: Site Public Contact

Ewa Beach
The Queen's Medical Center - West Oahu
Contact: Site Public Contact
Email: rohta@queens.org

Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
Contact: Site Public Contact
Email: i.webster@hawaiicancercare.com

Hawaii Cancer Care Inc-Liliha
Contact: Site Public Contact

Hawaii Diagnostic Radiology Services LLC
Contact: Site Public Contact
Email: mmiyoshi@hawaiidrs.com

Kapiolani Medical Center for Women and Children
Contact: Site Public Contact

Kuakini Medical Center
Contact: Site Public Contact

Queen's Cancer Cenrer - POB I
Contact: Site Public Contact

Queen's Cancer Center - Kuakini
Contact: Site Public Contact

Queen's Medical Center
Contact: Site Public Contact

Straub Clinic and Hospital
Contact: Site Public Contact

The Cancer Center of Hawaii-Liliha
Contact: Site Public Contact

University of Hawaii Cancer Center
Contact: Site Public Contact

Kahului
Straub Medical Center - Kahului Clinic
Contact: Site Public Contact
Email: lori.kam@hawaiipacifichealth.org

Kailua
Castle Medical Center
Contact: Site Public Contact
Email: ctsucontact@westat.com

Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
Contact: Site Public Contact

IA
Ames
Mary Greeley Medical Center
Contact: Site Public Contact

McFarland Clinic PC - Ames
Contact: Site Public Contact
Email: ksoder@mcfarlandclinic.com

Boone
McFarland Clinic PC-Boone
Contact: Site Public Contact

Carroll
Saint Anthony Regional Hospital
Contact: Site Public Contact
Email: sbenson@iora.org

Clive
Medical Oncology and Hematology Associates-West Des Moines
Contact: Site Public Contact

Mercy Cancer Center-West Lakes
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Council Bluffs
Alegent Health Mercy Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creston
Greater Regional Medical Center
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Des Moines
Broadlawns Medical Center
Contact: Site Public Contact

Iowa Lutheran Hospital
Contact: Site Public Contact

Iowa Methodist Medical Center
Contact: Site Public Contact

Medical Oncology and Hematology Associates-Des Moines
Contact: Site Public Contact

Mercy Medical Center - Des Moines
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
Contact: Site Public Contact

Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Contact: Site Public Contact

Trinity Regional Medical Center
Contact: Site Public Contact

Jefferson
McFarland Clinic PC-Jefferson
Contact: Site Public Contact

Marshalltown
McFarland Clinic PC-Marshalltown
Contact: Site Public Contact

West Des Moines
Mercy Medical Center-West Lakes
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Methodist West Hospital
Contact: Site Public Contact

IL
Alton
Saint Anthony's Health
Contact: Site Public Contact

Aurora
Rush - Copley Medical Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

Bloomington
Illinois CancerCare-Bloomington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
Contact: Site Public Contact
Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
Contact: Site Public Contact
Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Chicago
John H Stroger Jr Hospital of Cook County
Contact: Site Public Contact

Danville
Carle on Vermilion
Contact: Site Public Contact
Email: Research@carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Contact: Site Public Contact

Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Eureka
Illinois CancerCare-Eureka
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Contact: Site Public Contact

Harvey
Ingalls Memorial Hospital
Contact: Site Public Contact
Email: clinicaltrials@ingalls.org

Kewanee
Illinois CancerCare-Kewanee Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Macomb
Illinois CancerCare-Macomb
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com

Mount Vernon
Good Samaritan Regional Health Center
Contact: Site Public Contact

O'Fallon
Cancer Care Center of O'Fallon
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Ottawa
Illinois CancerCare-Ottawa Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Contact: Site Public Contact

Springfield Clinic
Contact: Site Public Contact

Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Contact: Site Public Contact
Email: Research@carle.com

Washington
Illinois CancerCare - Washington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Yorkville
Rush-Copley Healthcare Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

IN
Richmond
Reid Health
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org

KY
Bardstown
Flaget Memorial Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Saint Joseph Hospital East
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

London
Saint Joseph London
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Louisville
Jewish Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saints Mary and Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

UofL Health Medical Center Northeast
Contact: Site Public Contact
Email: ctoinfo@louisville.edu

Mount Sterling
Saint Joseph Mount Sterling
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Shepherdsville
Jewish Hospital Medical Center South
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

ME
South Portland
Maine Medical Partners Urology
Contact: Site Public Contact
Email: ClinicalResearch@mmc.org

MI
Adrian
Hickman Cancer Center
Contact: Site Public Contact

Ann Arbor
Saint Joseph Mercy Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Brighton
Saint Joseph Mercy Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
Saint Joseph Mercy Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Caro
Caro Cancer Center
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Chelsea
Saint Joseph Mercy Chelsea
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Clarkston
Hematology Oncology Consultants-Clarkston
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Detroit
Ascension Saint John Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

East China
Great Lakes Cancer Management Specialists-Doctors Park
Contact: Site Public Contact
Email: karen.forman@ascension.org

Flint
Genesee Cancer and Blood Disease Treatment Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesee Hematology Oncology PC
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesys Hurley Cancer Institute
Contact: Site Public Contact
Email: wstrong@ghci.org

Hurley Medical Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Grosse Pointe Woods
Academic Hematology Oncology Specialists
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Grosse Pointe Woods
Contact: Site Public Contact
Email: karen.forman@ascension.org

Lansing
Sparrow Hospital
Contact: Site Public Contact

Livonia
Hope Cancer Clinic
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Macomb Township
Contact: Site Public Contact
Email: karen.forman@ascension.org

Marlette
Saint Mary's Oncology/Hematology Associates of Marlette
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Monroe
Toledo Clinic Cancer Centers-Monroe
Contact: Site Public Contact

Pontiac
21st Century Oncology-Pontiac
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Hope Cancer Center
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Pontiac
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Oakland
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Saginaw
Ascension Saint Mary's Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Oncology Hematology Associates of Saginaw Valley PC
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Contact: Site Public Contact
Email: karen.forman@ascension.org

Tawas City
Ascension Saint Joseph Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Warren
Advanced Breast Care Center PLLC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Macomb Professional Building
Contact: Site Public Contact
Email: karen.forman@ascension.org

Macomb Hematology Oncology PC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Warren
Contact: Site Public Contact
Email: karen.forman@ascension.org

Saint John Macomb-Oakland Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

West Branch
Saint Mary's Oncology/Hematology Associates of West Branch
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Ypsilanti
Huron Gastroenterology PC
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

MN
Burnsville
Fairview Ridges Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minnesota Oncology - Burnsville
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Cambridge
Cambridge Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Edina
Fairview Southdale Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Health Partners Inc
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hennepin County Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

New Ulm
New Ulm Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Princeton
Fairview Northland Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Shakopee
Saint Francis Regional Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Waconia
Ridgeview Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Wyoming
Fairview Lakes Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org

Branson
Cox Cancer Center Branson
Contact: Site Public Contact

Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Contact: Site Public Contact

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Contact: Site Public Contact
Email: swooden@mail.crmc.org

Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Mercy Hospital South
Contact: Site Public Contact
Email: janet.lesko@mercy.net

Missouri Baptist Medical Center
Contact: Site Public Contact

Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Contact: Site Public Contact

Mercy Hospital Springfield
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Contact: Site Public Contact

NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu

NE
Grand Island
CHI Health Saint Francis
Contact: Site Public Contact

Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lincoln
Saint Elizabeth Regional Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Omaha
Alegent Health Bergan Mercy Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

NH
Concord
New Hampshire Oncology Hematology PA-Concord
Contact: Site Public Contact

Manchester
Solinsky Center for Cancer Care
Contact: Site Public Contact

NJ
New Brunswick
Saint Peter's University Hospital
Contact: Site Public Contact
Email: kcovert@saintpetersuh.com

NY
Bronx
James J Peters VA Medical Center
Contact: Site Public Contact
Email: kl2965@cumc.columbia.edu

Elmhurst
Elmhurst Hospital Center
Contact: Site Public Contact

Jamaica
Queens Hospital Center
Contact: Site Public Contact

OH
Beavercreek
Indu and Raj Soin Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Boardman
Saint Elizabeth Boardman Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Centerville
Dayton Physicians LLC-Miami Valley South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Oncology Hematology Care Inc-Kenwood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Dayton
Dayton Physician LLC-Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Findlay
Armes Family Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Blanchard Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Orion Cancer Care
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greenville
Dayton Physicians LLC-Wayne
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Wayne Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering
Greater Dayton Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield
Springfield Regional Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield Regional Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Toledo
Mercy Health - Saint Anne Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Toledo Clinic Cancer Centers-Toledo
Contact: Site Public Contact

Troy
Dayton Physicians LLC - Troy
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Warren
Saint Joseph Warren Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Youngstown
Saint Elizabeth Youngstown Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

OR
Portland
Oregon Health and Science University
Contact: Site Public Contact
Email: trials@ohsu.edu

Portland VA Medical Center
Contact: Site Public Contact

PA
Allentown
Lehigh Valley Hospital-Cedar Crest
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

East Stroudsburg
Pocono Medical Center
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Hazleton
Lehigh Valley Hospital-Hazleton
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Philadelphia
Thomas Jefferson University Hospital
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu

SC
Charleston
Medical University of South Carolina
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

Ralph H Johnson VA Medical Center
Contact: Site Public Contact
Email: ashley.salvo@va.gov

West Columbia
Lexington Medical Center
Contact: Site Public Contact
Email: LMCIRB@lexhealth.org

TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

San Antonio
Audie L Murphy VA Hospital
Contact: Site Public Contact

University of Texas Health Science Center at San Antonio
Contact: Site Public Contact
Email: phoresearchoffice@uthscsa.edu

VA
Alexandria
Inova Alexandria Hospital
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org

Fairfax
Inova Fair Oaks Hospital
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org

Inova Schar Cancer Institute
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org

Falls Church
Inova Fairfax Hospital
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org

Martinsville
Sovah Health Martinsville
Contact: Site Public Contact
Email: sharon.hubbard@lpnt.net

Richmond
VCU Massey Cancer Center at Stony Point
Contact: Site Public Contact
Email: ctoclinops@vcu.edu

Virginia Commonwealth University/Massey Cancer Center
Contact: Site Public Contact
Email: CTOclinops@vcu.edu

WI
New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

PRIMARY OBJECTIVE:
I. To compare the change in the percent (%) Ki-67 expression in a biopsy core positive for cancer from baseline to end-of-study (EOS) biopsy between men on active surveillance (AS) for prostate cancer (PCa), treated with green tea catechin (GTC) or placebo for 6 months.

SECONDARY OBJECTIVES:
I. To assess apoptosis by caspase in tumor tissue from EOS biopsy by treatment.
II. To assess % Ki-67: Apoptosis ratio from EOS biopsy by treatment.
III. To evaluate the number of biopsy cores positive for cancer from EOS biopsy by treatment.
IV. To evaluate the percentage of any biopsy tissue core positive for cancer from EOS biopsy by treatment.
V. To evaluate % Ki-67 in EOS biopsy from the same quadrant matching the quadrant with the highest % Ki-67 at baseline treatment.
VI. To evaluate the Gleason sum from EOS biopsy by treatment.
VII. To evaluate the change in serum prostate-specific antigen (PSA) from baseline to 3 months and to EOS by treatment.
VIII. To evaluate the safety of 6 month administration of GTC assessed by Common Terminology Criteria for Adverse Events (CTCAE), complete blood count (CBC), comprehensive metabolic panel (CMP) and liver function toxicities (LFTs) by treatment.
IX. To evaluate the change in geometric mean of % Ki-67 measures in all the cores positive for cancer from baseline to EOS biopsy by treatment.

EXPLORATORY OBJECTIVES:
I. To evaluate the change in catechin (epigallocatechin gallate [EGCG]) as indicated by change from EGCG measured in plasma from baseline and EOS by treatment.
II. To evaluate the adherence and acceptability to GTC based on the percentage compliance using agent logs (%) and pill counts monthly until EOS by treatment groups.
III. To evaluate the bioavailability of GTC as indicated by change from EGCG measured in plasma from baseline and EOS by treatment groups.

PATIENT REPORTED OUTCOMES OBJECTIVES:
I. To evaluate the change in lower urinary tract symptoms (LUTS) from baseline to 3 months and to EOS using the LUTS scale by treatment groups.
II. To evaluate the change in quality of life (QOL) scores from baseline to 3 months and to EOS using the Functional Assessment of Cancer Therapy (FACT)-Prostate by treatment groups.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive green tea catechins orally (PO) twice daily (BID) for up to 6 months in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive placebo PO BID for up to 6 months.

Patients are followed up at approximately 7 days and at 6 months after completion of study treatment and finally at 12 months after registration.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its NCI Community Oncology Research Program (NCORP).


EA8184 Home Page
ECOG-ACRIN Cancer Research Group