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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04597359
Other study ID # EA8184
Secondary ID NCI-2020-07173EA
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 5, 2021
Est. completion date December 31, 2032

Study information

Verified date April 2024
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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 catechins (GTCs) 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 Toxicity Criteria (CTC) version 5.0, 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. After completion of study, patients are followed up at approximately 7 days, at 6 months, and then up to 12 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date December 31, 2032
Est. primary completion date December 31, 2032
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo Administration
Given PO
Other:
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Drug:
Sinecatechins
Given PO

Locations

Country Name City State
Guam FHP Health Center-Guam Tamuning
Puerto Rico Cancer Center-Metro Medical Center Bayamon Bayamon
Puerto Rico Doctors Cancer Center Manati
Puerto Rico Centro Comprensivo de Cancer de UPR San Juan
Puerto Rico PROncology San Juan
Puerto Rico San Juan City Hospital San Juan
Puerto Rico San Juan Community Oncology Group San Juan
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States Straub Pearlridge Clinic 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States The Queen's Medical Center - West Oahu 'Ewa Beach Hawaii
United States Hickman Cancer Center Adrian Michigan
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Inova Alexandria Hospital Alexandria Virginia
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Saint Anthony's Health Alton Illinois
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Mission Cancer and Blood - Ankeny Ankeny Iowa
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Rocky Mountain Regional VA Medical Center Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States UCHealth University of Colorado Hospital Aurora Colorado
United States Mount Sinai Comprehensive Cancer Center at Aventura Aventura Florida
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Flaget Memorial Hospital Bardstown Kentucky
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Elizabeth Boardman Hospital Boardman Ohio
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States McFarland Clinic - Boone Boone Iowa
United States Boulder Community Foothills Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Cox Cancer Center Branson Branson Missouri
United States Harrison Medical Center Bremerton Washington
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States James J Peters VA Medical Center Bronx New York
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Highline Medical Center-Main Campus Burien Washington
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Cambridge Medical Center Cambridge Minnesota
United States Marshall Cancer Center Cameron Park California
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Mercy Cancer Center - Carmichael Carmichael California
United States Mercy San Juan Medical Center Carmichael California
United States Caro Cancer Center Caro Michigan
United States Saint Anthony Regional Hospital Carroll Iowa
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Rocky Mountain Cancer Centers - Centennial Centennial Colorado
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Saint Mary's Hospital Centralia Illinois
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Ralph H Johnson VA Medical Center Charleston South Carolina
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Chesapeake Regional Medical Center Chesapeake Virginia
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Saint Francis Cancer Center Colorado Springs Colorado
United States New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States Mercy Hospital Coon Rapids Minnesota
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States Carle at The Riverfront Danville Illinois
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Colorado Blood Cancer Institute Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States The Women's Imaging Center Denver Colorado
United States UCHealth - Cherry Creek Denver Colorado
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Illinois CancerCare-Dixon Dixon Illinois
United States Epic Care-Dublin Dublin California
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Mercy Cancer Center - Elk Grove Elk Grove California
United States Elmhurst Hospital Center Elmhurst New York
United States Bay Area Breast Surgeons Inc Emeryville California
United States Epic Care Partners in Cancer Care Emeryville California
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Rocky Mountain Cancer Centers - Swedish Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States The Melanoma and Skin Cancer Institute Englewood Colorado
United States Saint Elizabeth Hospital Enumclaw Washington
United States Illinois CancerCare-Eureka Eureka Illinois
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Inova Fair Oaks Hospital Fairfax Virginia
United States Inova Schar Cancer Institute Fairfax Virginia
United States Inova Fairfax Hospital Falls Church Virginia
United States Parkland Health Center - Farmington Farmington Missouri
United States Highlands Oncology Group - Fayetteville Fayetteville Arkansas
United States Saint Francis Hospital Federal Way Washington
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Cancer Care and Hematology-Fort Collins Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Holy Cross Hospital Fort Lauderdale Florida
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Unity Hospital Fridley Minnesota
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States CHI Health Saint Francis Grand Island Nebraska
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States UCHealth Greeley Hospital Greeley Colorado
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Wayne Hospital Greenville Ohio
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Hackensack University Medical Center Hackensack New Jersey
United States Ingalls Memorial Hospital Harvey Illinois
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States UCHealth Highlands Ranch Hospital Highlands Ranch Colorado
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Hawaii Diagnostic Radiology Services LLC Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Queens Hospital Center Jamaica New York
United States McFarland Clinic - Jefferson Jefferson Iowa
United States Capital Region Southwest Campus Jefferson City Missouri
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Straub Medical Center - Kahului Clinic Kahului Hawaii
United States Castle Medical Center Kailua Hawaii
United States CHI Health Good Samaritan Kearney Nebraska
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Saint Joseph Hospital Lexington Kentucky
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States CARTI Cancer Center Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Saint Joseph London London Kentucky
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States Jewish Hospital Louisville Kentucky
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States UofL Health Medical Center Northeast Louisville Kentucky
United States Medical Center of the Rockies Loveland Colorado
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States Solinsky Center for Cancer Care Manchester New Hampshire
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Contra Costa Regional Medical Center Martinez California
United States Sovah Health Martinsville Martinsville Virginia
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Mercy UC Davis Cancer Center Merced California
United States Mount Sinai Medical Center Miami Beach Florida
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Monticello Cancer Center Monticello Minnesota
United States Saint Joseph Mount Sterling Mount Sterling Kentucky
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Outer Banks Hospital Nags Head North Carolina
United States Saint Peter's University Hospital New Brunswick New Jersey
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States HSHS Saint Elizabeth's Hospital O'Fallon Illinois
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Tumor Institute Oakland California
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Lake Regional Hospital Osage Beach Missouri
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Mercy Health - Paducah Medical Oncology and Hematology Paducah Kentucky
United States Midlands Community Hospital Papillion Nebraska
United States Parker Adventist Hospital Parker Colorado
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Marshall Hospital Placerville California
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Jefferson Healthcare Port Townsend Washington
United States Oregon Health and Science University Portland Oregon
United States Portland VA Medical Center Portland Oregon
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Reid Health Richmond Indiana
United States VCU Massey Cancer Center at Stony Point Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mercy Cancer Center - Rocklin Rocklin California
United States Highlands Oncology Group - Rogers Rogers Arkansas
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Mercy Cancer Center - Sacramento Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Audie L Murphy VA Hospital San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States UCSF Cancer Center - San Mateo San Mateo California
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Maine Medical Partners Urology South Portland Maine
United States Highlands Oncology Group Springdale Arkansas
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Lakeview Hospital Stillwater Minnesota
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Mercy Health - Saint Anne Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Dayton Physicians LLC - Troy Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Ridgeview Medical Center Waconia Minnesota
United States Epic Care Cyberknife Center Walnut Creek California
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Saint Joseph Warren Hospital Warren Ohio
United States Illinois CancerCare - Washington Washington Illinois
United States MedStar Washington Hospital Center Washington District of Columbia
United States Mercy Hospital Washington Washington Missouri
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Lexington Medical Center West Columbia South Carolina
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Reading Hospital West Reading Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Woodland Memorial Hospital Woodland California
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Guam,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Other Compliance to study drug (standard pill counts) Compliance to study drug will be evaluated by standard pill counts. Will evaluate percentage compliance to study agent in the study arms using pill counts. Up to 6 months
Other Compliance to study drug (diet records) Compliance to study drug will be evaluated by diet records. Up to 6 months
Other Compliance to study drug (plasma concentrations of GTC) Compliance to study drug will be evaluated by plasma concentrations of GTC (epigallocatechin gallate [EGCG]). For plasma, will assess the change from baseline to end of treatment for GTC (EGCG) to estimate compliance and bioavailability. Up to 6 months
Other Epigallocatechin gallate (EGCG) concentrations Will correlate EGCG concentrations with prostate specific antigen density (PSAD) and prostate specific antigen doubling time (PSADT), using descriptive analysis with scatter plots and regression analysis, and adjusting intervention and known predictors including the stratification factors in multivariable analysis. Will transform to the square root or logarithmic transformation of the data to improve normality of the distributions (determined as the transformation (including untransformed) with the lowest Anderson-Darling normality score). Up to 6 months
Other Changes in lower urinary tract symptoms (LUTS) Lower urinary tract symptoms (LUTS) will be assessed using the American Urological Association Symptom Score for the evaluation, LUTS Symptom Scale. The highest score on the scale is 5, "almost always" and the lowest score on the scale is 0, "not at all". Baseline up to 6 months
Other Changes in lower urinary tract symptoms Will assess change in EGCG from baseline to EOS, adherence to GTC, and bioavailability of GTC from baseline to EOS by treatment. Baseline up to 6 months
Other Changes in quality of life (QOL) Quality of life will be assessed using the Functional Assessment of Cancer Therapy (FACT)-Prostate. Baseline up to 6 months
Other Changes in quality of life (QOL) Will assess change in EGCG from baseline to EOS, adherence to GTC, and bioavailability of GTC from baseline to EOS by treatment. Baseline up to 6 months
Primary Change in the highest percent Ki-67 expression Measured in a core positive for tumor from baseline to highest percent (%) Ki-67 expression measured in a core positive for tumor in the end of study (EOS) biopsy. This change will be compared between green tea catechins (GTC) and placebo arms. The highest % Ki-67 expressions from baseline and EOS biopsies will be used to estimate the change. If the change is not normally distributed, non-parametric test such as Wilcoxon-rank sum test or two-sample normal score test will be used to compare the changes in percent Ki-67 levels between the GTC and placebo arms. Baseline to 6 months
Secondary Apoptosis Will be assessed by caspase in tumor tissue from EOS biopsy by treatment. Up to 6 months
Secondary Apoptosis ratio Will be evaluated from EOS biopsy by treatment groups. Descriptive statistics with confidence intervals will be presented. For continuous measures, will use two-sample t-test or Wilcoxon rank sum test (if non-parametric test is more appropriate) to compare the measurements by treatment. Up to 6 months
Secondary Number of biopsy cores positive for cancer at end of study Descriptive statistics with confidence intervals will be presented. For binary measures, will use Fisher's test. At 6 months
Secondary Percent of any biopsy tissue core positive for cancer at end of study Descriptive statistics with confidence intervals will be presented. For continuous measures, will use two-sample t-test or Wilcoxon rank sum test (if non-parametric test is more appropriate) to compare the measurements by treatment. At 6 months
Secondary Percent Ki-67 Descriptive statistics with confidence intervals will be presented. For continuous measures, will use two-sample t-test or Wilcoxon rank sum test (if non-parametric test is more appropriate) to compare the measurements by treatment. Up to 6 months
Secondary Gleason sum at end of study Descriptive statistics with confidence intervals will be presented. For binary measures, will use Fisher's test. At 6 months
Secondary Change in serum prostate-specific antigen (PSA) Will use three mixed models (for PSA, PSA doubling time, and PSA density). For the first two, will log the PSA value. For PSA, will have intercepts and slopes for each patient, an unstructured covariance model, and 2 terms for the intercept and slope associated with the treatment group. For the PSA doubling time, will center the baseline values at 1, and estimate the slopes for each patient (from which the doubling time can be derived), along with a net slope effect for the treatment group. The mixed model for PSA density will be analogous to the one for PSA. Baseline up to 6 months
Secondary Incidence of adverse events Will be assessed by Common Toxicity Criteria version 5.0, complete blood count, comprehensive metabolic panel, and liver function toxicities by treatment. All toxicity data will be summarized by category and grade in a standard fashion. Proportions experiencing the most common types of toxicity in this trial will be estimated and 95% confidence intervals calculated. Adverse event rates (such as worst grade 3 or higher) by arm will be estimated and compared. Up to 12 months
Secondary Change in geometric mean of percent Ki-67 Descriptive statistics with confidence intervals will be presented. For binary measures, will use Fisher's test. Baseline up to 6 months
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