Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer
NCT ID: NCT00309985
Last Updated: 2025-12-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
790 participants
INTERVENTIONAL
2006-09-26
2025-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel
NCT03419234
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
NCT06592924
Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
NCT00002855
Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
NCT00110162
Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer
NCT00796458
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary
* Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer.
Secondary
* Determine whether early chemotherapy can increase the time to clinical progression (radiographic or symptomatic deterioration due to disease) over hormonal therapy alone.
* Determine whether early chemotherapy can increase the time to development of hormone-refractory disease over hormonal therapy alone.
* Determine whether early chemotherapy can increase the time to serological progression over hormonal therapy alone.
* Determine rates of biochemical response at 6 months and 12 months in the chemohormonal arm versus the hormonal therapy alone arm.
* Determine the frequency of adverse events and the tolerability of chemotherapy combined with hormonal therapy versus hormonal therapy alone.
* Determine whether the postulated clinically meaningful increase in disease control is associated with an alteration in overall quality of life using the Functional Assessment of Cancer Therapy-Prostate questionnaire.
* Determine the ability of prostate-specific antigen (PSA) changes to be a surrogate for clinical benefit from therapy and overall survival.
Tertiary
* Determine whether there are proteins differentially translated from the genome in hormone-sensitive prostate cancer, prostate cancer that has responded to hormonal therapy, and hormone-refractory prostate cancer.
* Determine the frequency of constitutive polymorphisms of enzymes involved in steroid metabolism and other carcinogenic processes.
* Determine whether the amount and frequency of certain carcinogenic proteins in prostate cancer tissue such as C-X-C chemokine receptor type 4 (CXCR-4) and manganese superoxide dismutase can be correlated with a poor prognosis.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (≥ 70 vs \< 70), ECOG performance status (0-1 vs 2), combined androgen blockade for \> 30 days (yes vs no), duration of prior adjuvant hormonal therapy (\> 12 months vs ≤ 12 months), concurrent bisphosphonate use (yes vs no), and volume of disease (low vs high). Patients are randomized to 1 of 2 treatment arms.
* Arm A (Androgen-Deprivation Therapy and Docetaxel): Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel intravenously (IV) over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm B (Androgen-Deprivation Therapy alone): Patients receive androgen-deprivation therapy (as in arm A) alone.
Quality of life is assessed at baseline and at months 3, 6, 9 and 12.
After completion of study treatment, patients are followed up periodically for up to 10 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Androgen-Deprivation Therapy and Docetaxel
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
androgen-deprivation therapy
LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.
docetaxel
Given IV
Androgen-Deprivation Therapy alone
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration) alone.
androgen-deprivation therapy
LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
androgen-deprivation therapy
LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.
docetaxel
Given IV
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Metastatic disease
* On androgen-deprivation therapy for \< 120 days
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* PS 2 eligible only if decline in PS is due to metastatic prostate cancer
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ upper limit of normal (ULN)
* Alanine aminotransferase (ALT) ≤ 2.5 times ULN
* Creatinine clearance ≥ 30 mL/min
* Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)
* Partial thromboplastin time (PTT) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)
* Fertile patients must use effective contraception
* At least 4 weeks since prior major surgery and recovered from all toxicity prior to randomization
* Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following are true:
* Therapy was discontinued ≥ 12 months ago AND there is no evidence of disease, as defined by 1 of the following:
* PSA \< 0.1 ng/dL after prostatectomy plus hormonal therapy
* PSA \< 0.5 ng/dL and has not doubled above nadir after radiotherapy plus hormonal therapy
* Therapy lasted no more than 24 months
* Last depot injection must have expired by the 24-month mark
* Prior palliative radiotherapy allowed if commenced within 30 days before starting androgen deprivation
* Anti-androgen therapy allowed as single-agent therapy ≤ 7 days before medial castration to prevent flare
* More than 30 days (or 6 half-lives) (whichever is longer) since prior participation in another clinical trial
* Concurrent participation in nontherapeutic trials allowed
* Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as sole hormonal therapy
Exclusion Criteria
* Prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma of the skin
* Other malignancies that are considered to have low potential to progress (e.g., grade 2, T1a transitional cell carcinoma) may be allowed if approved by study chair
* Peripheral neuropathy \> grade 1
* History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* Active cardiac disease, including the following:
* Active angina
* Symptomatic congestive heart failure
* Myocardial infarction within the past 6 months
* Prior chemotherapy in adjuvant or neoadjuvant setting
* Prior hormone therapy in the metastatic setting
* Concurrent 5-alpha reductase inhibitors
* Simultaneous enrollment on Cancer and Leukemia Group B (CALGB) 90202
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christopher Sweeney, MBBS
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Providence Cancer Center
Anchorage, Alaska, United States
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States
Peninsula Medical Center
Burlingame, California, United States
California Cancer Care, Incorporated - Greenbrae
Greenbrae, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, United States
Mather Veteran Affairs Medical Center
Mather, California, United States
Mercy Cancer Center at Mercy Medical Center
Merced, California, United States
Memorial Medical Center
Modesto, California, United States
Sutter Health - Western Division Cancer Research Group
Novato, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
California Pacific Medical Center - California Campus
San Francisco, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Saint Helena Hospital
St. Helena, California, United States
Tahoe Forest Cancer Center
Truckee, California, United States
Sutter Solano Medical Center
Vallejo, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
Shaw Regional Cancer Center
Edwards, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States
Idaho Urologic Institute, PA
Meridian, Idaho, United States
Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute
Nampa, Idaho, United States
Mountain States Tumor Institute at St. Luke's
Twin Falls, Idaho, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Illinois CancerCare - Canton
Canton, Illinois, United States
Illinois CancerCare - Carthage
Carthage, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Hematology and Oncology Associates
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Illinois CancerCare - Eureka
Eureka, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
St. Francis Hospital
Evanston, Illinois, United States
Galesburg Clinic, PC
Galesburg, Illinois, United States
Illinois CancerCare - Cottage
Galesburg, Illinois, United States
Illinois CancerCare - Havana
Havana, Illinois, United States
Kellogg Cancer Care Center
Highland Park, Illinois, United States
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
Provena St. Mary's Regional Cancer Center - Kankakee
Kankakee, Illinois, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States
La Grange Memorial Hospital
La Grange, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States
Illinois CancerCare - Macomb
Macomb, Illinois, United States
McDonough District Hospital
Macomb, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Hematology Oncology Consultants - Naperville
Naperville, Illinois, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States
Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
Normal, Illinois, United States
Community Hospital of Ottawa
Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Illinois CancerCare - Pekin
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Illinois CancerCare - Peru
Peru, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Illinois CancerCare - Princeton
Princeton, Illinois, United States
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis
Indianapolis, Indiana, United States
William N. Wishard Memorial Hospital
Indianapolis, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States
Veterans Affairs Medical Center - Iowa City
Iowa City, Iowa, United States
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Hays Medical Center
Hays, Kansas, United States
Hutchinson Hospital Corporation
Hutchinson, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Mount Carmel Regional Cancer Center
Pittsburg, Kansas, United States
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Jordan Hospital Club Cancer Center
Plymouth, Massachusetts, United States
Commonwealth Hematology-Oncology, PC - Quincy
Quincy, Massachusetts, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, United States
Foote Memorial Hospital
Jackson, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
St. Mary Mercy Hospital
Livonia, Michigan, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
MeritCare Bemidji
Bemidji, Minnesota, United States
St. Joseph's Medical Center
Brainerd, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States
CCOP - Duluth
Duluth, Minnesota, United States
Miller - Dwan Medical Center
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology - Woodbury
Woodbury, Minnesota, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Central Care Cancer Center at Carrie J. Babb Cancer Center
Bolivar, Missouri, United States
Skaggs Cancer Center at Skaggs Regional Medical Center
Branson, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Midwest Hematology Oncology Group, Incorporated
St Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
St. James Healthcare Cancer Care
Butte, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
Kings County Hospital Center
Brooklyn, New York, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Dickstein Cancer Treatment Center at White Plains Hospital Center
White Plains, New York, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States
MeritCare Broadway
Fargo, North Dakota, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, United States
Roger Maris Cancer Center at MeritCare Hospital
Fargo, North Dakota, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Cleveland Clinic Beachwood Family Health and Surgery Center
Beachwood, Ohio, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grant Medical Center Cancer Care
Columbus, Ohio, United States
Zangmeister Center
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Cleveland Clinic Cancer Center
Independence, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
St. Rita's Medical Center
Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Parma Community General Hospital
Parma, Ohio, United States
Southern Ohio Medical Center Cancer Center
Portsmouth, Ohio, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
Cleveland Clinic Foundation - Strongsville
Strongsville, Ohio, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
St. Joseph Medical Center
Reading, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States
University Hospital - San Antonio
San Antonio, Texas, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Lynchburg Hematology-Oncology Clinic
Lynchburg, Virginia, United States
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland, Washington, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Pacific Medical Center
Seattle, Washington, United States
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States
Langlade Memorial Hospital
Antigo, Wisconsin, United States
Marshfield Clinic - Chippewa Center
Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States
Dean Medical Center - Madison
Madison, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Vince Lombardi Cancer Clinic - Marinette
Marinette, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States
St. Nicholas Hospital
Sheboygan, Wisconsin, United States
Vince Lombardi Cancer Clinic - Sheboygan
Sheboygan, Wisconsin, United States
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Saint Michael's Hospital Cancer Center
Stevens Point, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Aurora Medical Center
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic - Two Rivers
Two Rivers, Wisconsin, United States
Marshfield Clinic - Wausau Center
Wausau, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Oncology Alliance, SC - Milwaukee - West
Wauwatosa, Wisconsin, United States
Diagnostic and Treatment Center
Weston, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015 Aug 20;373(8):737-46. doi: 10.1056/NEJMoa1503747. Epub 2015 Aug 5.
Lage DE, Michaelson MD, Lee RJ, Greer JA, Temel JS, Sweeney CJ. Outcomes of older men receiving docetaxel for metastatic hormone-sensitive prostate cancer. Prostate Cancer Prostatic Dis. 2021 Dec;24(4):1181-1188. doi: 10.1038/s41391-021-00389-2. Epub 2021 May 18.
Martini A, Pfail J, Montorsi F, Galsky MD, Oh WK. Surrogate endpoints for overall survival for patients with metastatic hormone-sensitive prostate cancer in the CHAARTED trial. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):638-645. doi: 10.1038/s41391-020-0231-5. Epub 2020 Apr 20.
Morgans AK, Chen YH, Sweeney CJ, Jarrard DF, Plimack ER, Gartrell BA, Carducci MA, Hussain M, Garcia JA, Cella D, DiPaola RS, Patrick-Miller LJ. Quality of Life During Treatment With Chemohormonal Therapy: Analysis of E3805 Chemohormonal Androgen Ablation Randomized Trial in Prostate Cancer. J Clin Oncol. 2018 Apr 10;36(11):1088-1095. doi: 10.1200/JCO.2017.75.3335. Epub 2018 Mar 9.
Kyriakopoulos CE, Chen YH, Carducci MA, Liu G, Jarrard DF, Hahn NM, Shevrin DH, Dreicer R, Hussain M, Eisenberger M, Kohli M, Plimack ER, Vogelzang NJ, Picus J, Cooney MM, Garcia JA, DiPaola RS, Sweeney CJ. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial. J Clin Oncol. 2018 Apr 10;36(11):1080-1087. doi: 10.1200/JCO.2017.75.3657. Epub 2018 Jan 31.
Harshman LC, Chen YH, Liu G, Carducci MA, Jarrard D, Dreicer R, Hahn N, Garcia JA, Hussain M, Shevrin D, Eisenberger M, Kohli M, Plimack ER, Cooney M, Vogelzang NJ, Picus J, Dipaola R, Sweeney CJ; ECOG-ACRIN 3805 Investigators. Seven-Month Prostate-Specific Antigen Is Prognostic in Metastatic Hormone-Sensitive Prostate Cancer Treated With Androgen Deprivation With or Without Docetaxel. J Clin Oncol. 2018 Feb 1;36(4):376-382. doi: 10.1200/JCO.2017.75.3921. Epub 2017 Dec 20.
Scott E. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Department of Medicine; Department of Biostatistics and Computational Biology; Dana-Farber Cancer Institute, Boston; Harvard Medical School, Boston; Johns Hopkins University, Baltimore; University of Wisconsin Carbone Cancer Center; School of Medicine and Public Health; Madison; Fox Chase Cancer Center, Temple University Health System, Philadelphia; Indiana University Melvin and Bren Simon Cancer Center, Indianapolis; Mayo Clinic, Rochester, MN; University Hospitals Case Medical Center, Seidman Cancer Center; Cleveland Clinic Taussig Cancer Institute; Both in Cleveland; University of Virginia Cancer Center, Charlottesville; Comprehensive Cancer Centers of Nevada, Las Vegas; Siteman Cancer Center, Washington University School of Medicine, St. Louis; NorthShore University Health System, Evanston, IL; University of Michigan Comprehensive Cancer Center, Ann Arbor; Rutgers Cancer Institute of New Jersey, New Brunswick.N Engl J Med. 2015 Aug 20;373(8):737-46. [Epub 2015 Aug 5]. doi: 10.1056/NEJMoa1503747. Urol Oncol. 2017 Mar;35(3):123. doi: 10.1016/j.urolonc.2016.12.021. Epub 2017 Feb 1.
Related Links
Access external resources that provide additional context or updates about the study.
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E3805
Identifier Type: OTHER
Identifier Source: secondary_id
E3805
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.