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])
- Patient’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 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 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 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
- 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
Ft. Smith
Mercy Hospital Fort Smith
Status: ACTIVE
Contact: Site Public Contact
Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
AZ
Phoenix
Cancer Center at Saint Joseph's
Status: ACTIVE
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Email: CancerInstitute@DignityHealth.org
CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Dublin
Epic Care-Dublin
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Emeryville
Bay Area Breast Surgeons Inc
Status: ACTIVE
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Epic Care Partners in Cancer Care
Status: ACTIVE
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Martinez
Contra Costa Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Oakland
Alta Bates Summit Medical Center - Summit Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Bay Area Tumor Institute
Status: ACTIVE
Contact: Site Public Contact
Email: lradke@bati.org
San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Status: ACTIVE
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Email: ResearchInstituteInquiries@CommonSpirit.org
San Mateo
UCSF Cancer Center - San Mateo
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrials@ucsf.edu
Santa Maria
Mission Hope Medical Oncology - Santa Maria
Status: ACTIVE
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Email: ResearchInstituteInquiries@CommonSpirit.org
Walnut Creek
Epic Care Cyberknife Center
Status: ACTIVE
Contact: Site Public Contact
Email: somega@bati.org
CO
Aurora
University of Colorado Hospital
Status: ACTIVE
Contact: Site Public Contact
Colorado Springs
Penrose-Saint Francis Healthcare
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org
Rocky Mountain Cancer Centers-Penrose
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org
Denver
Porter Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org
Durango
Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org
Southwest Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org
Fort Collins
Cancer Care and Hematology-Fort Collins
Status: ACTIVE
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Poudre Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Greeley
UCHealth Greeley Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Highlands Ranch
UCHealth Highlands Ranch Hospital
Status: ACTIVE
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Lakewood
Saint Anthony Hospital
Status: ACTIVE
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Email: ResearchTracking@Centura.Org
Littleton
Littleton Adventist Hospital
Status: ACTIVE
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Email: ResearchTracking@Centura.Org
Longmont
Longmont United Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org
Rocky Mountain Cancer Centers-Longmont
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org
Loveland
Medical Center of the Rockies
Status: ACTIVE
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Parker
Parker Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org
Pueblo
Saint Mary Corwin Medical Center
Status: ACTIVE
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Email: ResearchTracking@Centura.Org
DC
Washington
MedStar Washington Hospital Center
Status: ACTIVE
Contact: Site Public Contact
FL
Aventura
Mount Sinai Comprehensive Cancer Center at Aventura
Status: ACTIVE
Contact: Site Public Contact
Email: yenrique@msmc.com
Fort Lauderdale
Holy Cross Hospital
Status: ACTIVE
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Miami Beach
Mount Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: yenrique@msmc.com
GU
Tamuning
FHP Health Center-Guam
Status: ACTIVE
Contact: Site Public Contact
HI
Aiea
Hawaii Cancer Care - Savio
Status: ACTIVE
Contact: Site Public Contact
Email: info@hawaiicancercare.com
Pali Momi Medical Center
Status: ACTIVE
Contact: Site Public Contact
Queen's Cancer Center - Pearlridge
Status: ACTIVE
Contact: Site Public Contact
Straub Pearlridge Clinic
Status: ACTIVE
Contact: Site Public Contact
The Cancer Center of Hawaii-Pali Momi
Status: ACTIVE
Contact: Site Public Contact
Ewa Beach
The Queen's Medical Center - West Oahu
Status: ACTIVE
Contact: Site Public Contact
Email: rohta@queens.org
Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
Status: ACTIVE
Contact: Site Public Contact
Email: i.webster@hawaiicancercare.com
Hawaii Cancer Care Inc-Liliha
Status: ACTIVE
Contact: Site Public Contact
Hawaii Diagnostic Radiology Services LLC
Status: ACTIVE
Contact: Site Public Contact
Email: mmiyoshi@hawaiidrs.com
Kapiolani Medical Center for Women and Children
Status: ACTIVE
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Kuakini Medical Center
Status: ACTIVE
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Queen's Cancer Cenrer - POB I
Status: ACTIVE
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Queen's Cancer Center - Kuakini
Status: ACTIVE
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Queen's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Straub Clinic and Hospital
Status: ACTIVE
Contact: Site Public Contact
The Cancer Center of Hawaii-Liliha
Status: ACTIVE
Contact: Site Public Contact
University of Hawaii Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Kahului
Straub Medical Center - Kahului Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: lori.kam@hawaiipacifichealth.org
Kailua
Castle Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ctsucontact@westat.com
Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
Status: ACTIVE
Contact: Site Public Contact
IA
Ames
Mary Greeley Medical Center
Status: ACTIVE
Contact: Site Public Contact
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Email: ksoder@mcfarlandclinic.com
Boone
McFarland Clinic PC-Boone
Status: ACTIVE
Contact: Site Public Contact
Carroll
Saint Anthony Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sbenson@iora.org
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: ACTIVE
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org
Mercy Cancer Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org
Council Bluffs
Alegent Health Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Creston
Greater Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org
Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Iowa Lutheran Hospital
Status: ACTIVE
Contact: Site Public Contact
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Medical Oncology and Hematology Associates-Laurel
Status: ACTIVE
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Trinity Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Jefferson
McFarland Clinic PC-Jefferson
Status: ACTIVE
Contact: Site Public Contact
Marshalltown
McFarland Clinic PC-Marshalltown
Status: ACTIVE
Contact: Site Public Contact
West Des Moines
Mercy Medical Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org
Methodist West Hospital
Status: ACTIVE
Contact: Site Public Contact
IL
Alton
Saint Anthony's Health
Status: ACTIVE
Contact: Site Public Contact
Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com
Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Carbondale
Memorial Hospital of Carbondale
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.research@sih.net
Carterville
SIH Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.research@sih.net
Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Chicago
John H Stroger Jr Hospital of Cook County
Status: ACTIVE
Contact: Site Public Contact
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Dixon
Illinois CancerCare-Dixon
Status: ACTIVE
Contact: Site Public Contact
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Harvey
Ingalls Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinicaltrials@ingalls.org
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: pallante.beth@mhsil.com
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com
The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com
Washington
Illinois CancerCare - Washington
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Yorkville
Rush-Copley Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com
IN
Richmond
Reid Health
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
KS
Garden City
Central Care Cancer Center - Garden City
Status: ACTIVE
Contact: Site Public Contact
Email: aroland@kccop.org
Great Bend
Central Care Cancer Center - Great Bend
Status: ACTIVE
Contact: Site Public Contact
Email: aroland@kccop.org
KY
Bardstown
Flaget Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Corbin
Commonwealth Cancer Center-Corbin
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Lexington
Saint Joseph Hospital East
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Saint Joseph Radiation Oncology Resource Center
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
London
Saint Joseph London
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Louisville
Jewish Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Saints Mary and Elizabeth Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
UofL Health Medical Center Northeast
Status: ACTIVE
Contact: Site Public Contact
Email: ctoinfo@louisville.edu
Shepherdsville
Jewish Hospital Medical Center South
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
MI
Adrian
Hickman Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Canton
IHA Hematology Oncology Consultants-Canton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Caro
Caro Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Clarkston
Hematology Oncology Consultants-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Newland Medical Associates-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Detroit
Ascension Saint John Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
East China
Great Lakes Cancer Management Specialists-Doctors Park
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org
Genesee Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org
Hurley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org
Grosse Pointe Woods
Academic Hematology Oncology Specialists
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
Michigan Breast Specialists-Grosse Pointe Woods
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
Lansing
Sparrow Hospital
Status: ACTIVE
Contact: Site Public Contact
Livonia
Hope Cancer Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
Michigan Breast Specialists-Macomb Township
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
Marlette
Saint Mary's Oncology / Hematology Associates of Marlette
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org
Monroe
Toledo Clinic Cancer Centers-Monroe
Status: ACTIVE
Contact: Site Public Contact
Pontiac
21st Century Oncology-Pontiac
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Hope Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Newland Medical Associates-Pontiac
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Saint Joseph Mercy Oakland
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Saginaw
Ascension Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org
Oncology Hematology Associates of Saginaw Valley PC
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org
Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
Tawas City
Ascension Saint Joseph Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org
Warren
Advanced Breast Care Center PLLC
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
Great Lakes Cancer Management Specialists-Macomb Professional Building
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
Macomb Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
Michigan Breast Specialists-Warren
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
Saint John Macomb-Oakland Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org
Ypsilanti
Huron Gastroenterology PC
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
IHA Hematology Oncology Consultants-Ann Arbor
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
MN
Burnsville
Fairview Ridges Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Minnesota Oncology - Burnsville
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Cambridge
Cambridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Edina
Fairview Southdale Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Minneapolis
Abbott-Northwestern Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Health Partners Inc
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Monticello
Monticello Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
New Ulm
New Ulm Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Princeton
Fairview Northland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Robbinsdale
North Memorial Medical Health Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
United Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Shakopee
Saint Francis Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Stillwater
Lakeview Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Waconia
Ridgeview Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Willmar
Rice Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
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Wyoming
Fairview Lakes Medical Center
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MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar
Central Care Cancer Center - Bolivar
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Branson
Cox Cancer Center Branson
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Cape Girardeau
Saint Francis Medical Center
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Email: sfmc@sfmc.net
Southeast Cancer Center
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Farmington
Parkland Health Center - Farmington
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Jefferson City
Capital Region Southwest Campus
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Joplin
Freeman Health System
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Mercy Hospital Joplin
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Rolla
Delbert Day Cancer Institute at PCRMC
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Email: research@phelpshealth.org
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
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Saint Joseph
Heartland Regional Medical Center
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Email: linda.schumacher@mymlc.com
Saint Louis
Mercy Hospital Saint Louis
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Mercy Hospital South
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Missouri Baptist Medical Center
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Saint Louis Cancer and Breast Institute-South City
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Sainte Genevieve
Sainte Genevieve County Memorial Hospital
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Springfield
CoxHealth South Hospital
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Mercy Hospital Springfield
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Sullivan
Missouri Baptist Sullivan Hospital
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Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
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Washington
Mercy Hospital Washington
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NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
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Email: cancerclinicaltrials@med.unc.edu
NE
Grand Island
CHI Health Saint Francis
Status: ACTIVE
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Kearney
CHI Health Good Samaritan
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Lincoln
Saint Elizabeth Regional Medical Center
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Omaha
Alegent Health Bergan Mercy Medical Center
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Alegent Health Lakeside Hospital
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Creighton University Medical Center
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Papillion
Midlands Community Hospital
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NH
Concord
New Hampshire Oncology Hematology PA-Concord
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Manchester
Solinsky Center for Cancer Care
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NJ
New Brunswick
Saint Peter's University Hospital
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NY
Bronx
James J Peters VA Medical Center
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Email: kl2965@cumc.columbia.edu
OH
Beavercreek
Indu and Raj Soin Medical Center
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Boardman
Saint Elizabeth Boardman Hospital
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Centerville
Dayton Physicians LLC-Miami Valley South
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Miami Valley Hospital South
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Cincinnati
Bethesda North Hospital
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Oncology Hematology Care Inc-Kenwood
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TriHealth Cancer Institute-Anderson
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Dayton
Dayton Physician LLC-Miami Valley Hospital North
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Miami Valley Hospital
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Miami Valley Hospital North
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Findlay
Armes Family Cancer Center
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Blanchard Valley Hospital
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Email: clinical.trials@daytonncorp.org
Orion Cancer Care
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Franklin
Atrium Medical Center-Middletown Regional Hospital
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Email: clinical.trials@daytonncorp.org
Dayton Physicians LLC-Atrium
Status: ACTIVE
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Greenville
Dayton Physicians LLC-Wayne
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Wayne Hospital
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Kettering
Greater Dayton Cancer Center
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Kettering Medical Center
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Springfield
Springfield Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Springfield Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Toledo
Mercy Health - Saint Anne Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Email: sheree@columbusccop.org
Toledo Clinic Cancer Centers-Toledo
Status: ACTIVE
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Troy
Dayton Physicians LLC-Upper Valley
Status: ACTIVE
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Upper Valley Medical Center
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Warren
Saint Joseph Warren Hospital
Status: ACTIVE
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Youngstown
Saint Elizabeth Youngstown Hospital
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OK
Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
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University of Oklahoma Health Sciences Center
Status: ACTIVE
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OR
Portland
Oregon Health and Science University
Status: ACTIVE
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Email: trials@ohsu.edu
PA
Allentown
Lehigh Valley Hospital-Cedar Crest
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Bethlehem
Lehigh Valley Hospital - Muhlenberg
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Email: Morgan_M.Horton@lvhn.org
East Stroudsburg
Pocono Medical Center
Status: ACTIVE
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Email: Morgan_M.Horton@lvhn.org
Hazleton
Lehigh Valley Hospital-Hazleton
Status: ACTIVE
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Email: Morgan_M.Horton@lvhn.org
Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE
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Email: ONCTrialNow@jefferson.edu
SC
Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu
Ralph H Johnson VA Medical Center
Status: ACTIVE
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Email: ashley.salvo@va.gov
West Columbia
Lexington Medical Center
Status: ACTIVE
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Email: LMCIRB@lexhealth.org
TX
Bryan
Saint Joseph Regional Cancer Center
Status: ACTIVE
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Email: ResearchInstituteInquiries@CommonSpirit.org
San Antonio
Audie L Murphy VA Hospital
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VA
Martinsville
Sovah Health Martinsville
Status: ACTIVE
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Email: sharon.hubbard@lpnt.net
WA
Bremerton
Harrison Medical Center
Status: ACTIVE
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Email: ResearchInstituteInquiries@CommonSpirit.org
Burien
Highline Medical Center-Main Campus
Status: ACTIVE
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Email: ResearchInstituteInquiries@CommonSpirit.org
Enumclaw
Saint Elizabeth Hospital
Status: ACTIVE
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Email: ResearchInstituteInquiries@CommonSpirit.org
Federal Way
Saint Francis Hospital
Status: ACTIVE
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Email: ResearchInstituteInquiries@CommonSpirit.org
Lakewood
Saint Clare Hospital
Status: ACTIVE
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Email: ResearchInstituteInquiries@CommonSpirit.org
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Status: ACTIVE
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Email: ResearchInstituteInquiries@CommonSpirit.org
WI
New Richmond
Cancer Center of Western Wisconsin
Status: ACTIVE
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).
