AzTrials
AzTrials

Metastatic Hormone-sensitive Prostate CancerPhase 3CHAARTEDNCT00309985

Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer

A Phase 3 study testing androgen-deprivation therapy and docetaxel in people with Metastatic Hormone-sensitive Prostate Cancer, run by ECOG-ACRIN Cancer Research Group at 343 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
androgen-deprivation therapy and docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
790 participants
Where
343 sitesUnited States
Study dates
26 Sep 2006to 31 Jan 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed prostate cancer
  • 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
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  • 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

Who cannot join

  • Prostate-specific antigen (PSA) level has risen and met criteria for progression from its lowest point between the start of androgen-deprivation therapy and randomization
  • 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:
Show all 13Show fewer
  • 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

Trial locations and contacts

343 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • DeCesaris Cancer Institute at Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Langlade Memorial Hospital

    Antigo, Wisconsin, 54409

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Veterans Affairs Medical Center - Baltimore

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center Cancer Center

    Baltimore, Maryland, 21204

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Cleveland Clinic Beachwood Family Health and Surgery Center

    Beachwood, Ohio, 44122

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, 94704

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Central Care Cancer Center at Carrie J. Babb Cancer Center

    Bolivar, Missouri, 65613

  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • St. Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Skaggs Cancer Center at Skaggs Regional Medical Center

    Branson, Missouri, 65616

  • Kings County Hospital Center

    Brooklyn, New York, 11203

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Graham Hospital

    Canton, Illinois, 61520

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • West Virginia University Health Sciences Center - Charleston

    Charleston, West Virginia, 25304

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Marshfield Clinic - Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates - West Des Moines

    Clive, Iowa, 50325

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology-Oncology, PC - Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • Evanston Hospital

    Evanston, Illinois, 60201-1781

  • St. Francis Hospital

    Evanston, Illinois, 60202

  • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • MeritCare Broadway

    Fargo, North Dakota, 58102

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • Roger Maris Cancer Center at MeritCare Hospital

    Fargo, North Dakota, 58122

  • Hunterdon Regional Cancer Center at Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Illinois CancerCare - Cottage

    Galesburg, Illinois, 61401

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • California Cancer Care, Incorporated - Greenbrae

    Greenbrae, California, 94904

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644

  • Hays Medical Center

    Hays, Kansas, 67601

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania, 18201

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Kellogg Cancer Care Center

    Highland Park, Illinois, 60035

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Hutchinson Hospital Corporation

    Hutchinson, Kansas, 67502

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Veterans Affairs Medical Center - Indianapolis

    Indianapolis, Indiana, 46202

  • William N. Wishard Memorial Hospital

    Indianapolis, Indiana, 46202

  • Veterans Affairs Medical Center - Iowa City

    Iowa City, Iowa, 52246

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • UW Cancer Center Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Provena St. Mary's Regional Cancer Center - Kankakee

    Kankakee, Illinois, 60901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Illinois CancerCare - Kewanee Clinic

    Kewanee, Illinois, 61443

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Cascade Cancer Center at Evergreen Hospital Medical Center

    Kirkland, Washington, 98033

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • North Shore Oncology and Hematology Associates, Limited - Libertyville

    Libertyville, Illinois, 60048

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Lynchburg Hematology-Oncology Clinic

    Lynchburg, Virginia, 24501

  • Illinois CancerCare - Macomb

    Macomb, Illinois, 61455

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Dean Medical Center - Madison

    Madison, Wisconsin, 53717

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Holy Family Memorial Medical Center Cancer Care Center

    Manitowoc, Wisconsin, 54221-1450

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology - Maplewood

    Maplewood, Minnesota, 55109

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Vince Lombardi Cancer Clinic - Marinette

    Marinette, Wisconsin, 54143

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP

    Marysville, California, 95901

  • Mather Veteran Affairs Medical Center

    Mather, California, 95655

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Mercy Cancer Center at Mercy Medical Center

    Merced, California, 95340

  • Idaho Urologic Institute, PA

    Meridian, Idaho, 83642

  • Mountain States Tumor Institute - Meridian

    Meridian, Idaho, 83642

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Tucker Center for Cancer Care at Orange Regional Medical Center

    Middletown, New York, 10940-4199

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Michiana Hematology-Oncology, PC - South Bend

    Mishawaka, Indiana, 46545-1470

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545-1470

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Memorial Medical Center

    Modesto, California, 95355

  • Illinois CancerCare - Monmouth

    Monmouth, Illinois, 61462

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Morristown, New Jersey, 07960

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Saint Luke's Mountain States Tumor Institute

    Nampa, Idaho, 83686

  • Hematology Oncology Consultants - Naperville

    Naperville, Illinois, 60540

  • MBCCOP - Meharry Medical College - Nashville

    Nashville, Tennessee, 37208-3599

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Yale Cancer Center

    New Haven, Connecticut, 06520-8028

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Medical Center of Louisiana - New Orleans

    New Orleans, Louisiana, 70112

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

  • Cancer Care and Hematology Specialists of Chicagoland - Niles

    Niles, Illinois, 60714

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Illinois CancerCare - Community Cancer Center

    Normal, Illinois, 61761

  • Mid-Illinois Hematology-Oncology Associates at Community Cancer Center

    Normal, Illinois, 61761

  • Sutter Health - Western Division Cancer Research Group

    Novato, California, 94945

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • McCreery Cancer Center at Ottumwa Regional

    Ottumwa, Iowa, 52501

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Parma Community General Hospital

    Parma, Ohio, 44129

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Illinois CancerCare - Pekin

    Pekin, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Illinois CancerCare - Peru

    Peru, Illinois, 61354

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Mount Carmel Regional Cancer Center

    Pittsburg, Kansas, 66762

  • Michiana Hematology Oncology PC - Plymouth

    Plymouth, Indiana, 46563

  • Jordan Hospital Club Cancer Center

    Plymouth, Massachusetts, 02360

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Southern Ohio Medical Center Cancer Center

    Portsmouth, Ohio, 45662

  • Illinois CancerCare - Princeton

    Princeton, Illinois, 61356

  • Commonwealth Hematology-Oncology, PC - Quincy

    Quincy, Massachusetts, 02169

  • St. Joseph Medical Center

    Reading, Pennsylvania, 19605

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Ministry Medical Group at Saint Mary's Hospital

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Lakeside Cancer Specialists, PLLC

    Saint Joseph, Michigan, 49085

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78209

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Cancer Therapy and Research Center

    San Antonio, Texas, 78229

  • University Hospital - San Antonio

    San Antonio, Texas, 78229

  • California Pacific Medical Center - California Campus

    San Francisco, California, 94118

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Pacific Medical Center

    Seattle, Washington, 98104

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • St. Nicholas Hospital

    Sheboygan, Wisconsin, 53081

  • Vince Lombardi Cancer Clinic - Sheboygan

    Sheboygan, Wisconsin, 53081

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51102

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Hematology Oncology Associates - Skokie

    Skokie, Illinois, 60076

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Frederick R. and Betty M. Smith Cancer Treatment Center

    Sparta, New Jersey, 07871

  • Illinois CancerCare - Spring Valley

    Spring Valley, Illinois, 61362

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

Other trials in United States

About this study

Official title: CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer.

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.

Read the detailed description

OBJECTIVES:

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.

Being tested
androgen-deprivation therapy, docetaxel
Keywords
metastatic hormone-sensitive prostate cancer, docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • androgen-deprivation therapyDrug

    LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.

  • docetaxelDrug

    Also called Taxotere, RP 56976, NSC #628503

    Given IV

Study groups in NCT00309985
Study groupRoleWhat they receive
Androgen-Deprivation Therapy and DocetaxelExperimentalPatients 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.
Receives: Drug: androgen-deprivation therapy; Drug: docetaxel
Androgen-Deprivation Therapy aloneActive comparatorPatients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration) alone.
Receives: Drug: androgen-deprivation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.

    Measured: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Secondary outcomes (5)

  1. Time to Clinical Progression

    Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.

    Measured: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

  2. Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)

    Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.

    Measured: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

  3. Proportion of Patients With PSA Complete Response (CR) at 6 Months

    PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.

    Measured: Assessed at 6 months

  4. Proportion of Patients With PSA Complete Response (CR) at 12 Months

    PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.

    Measured: Assessed at 12 months

  5. QOL Change From Baseline to 3 Months

    The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.

    Measured: Assessed at baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2006 (estimated)
  2. Study start26 Sep 2006
  3. Primary completion23 Dec 2013
  4. Study completion31 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
790 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00309985
Sponsor's protocol ID
E3805
Other IDs
E3805, U10CA180794
Acronym
CHAARTED
Status last verified
Mar 2025
First submitted
29 Mar 2006
Last updated
11 Dec 2025
Data monitoring committee
Yes
Individual data sharing
Yes: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Publications

  • 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.

    PubMed 26244877

  • Guo S, Zhang J, Halabi S. Joint Modelling of Longitudinal Measurements and Time-to-Event Outcomes With a Cure Fraction Using Functional Principal Component Analysis. Stat Med. 2024 Dec 30;43(30):6059-6072. doi: 10.1002/sim.10289. Epub 2024 Dec 5.

    PubMed 39633601

  • Jimenez N, Garcia de Herreros M, Reig O, Marin-Aguilera M, Aversa C, Ferrer-Mileo L, Garcia-Esteve S, Rodriguez-Carunchio L, Trias I, Font A, Rodriguez-Vida A, Climent MA, Cros S, Chirivella I, Domenech M, Figols M, Carles J, Suarez C, Herrero Rivera D, Gonzalez-Billalabeitia E, Civico C, Sala-Gonzalez N, Ruiz de Porras V, Ribal MJ, Prat A, Mellado B. Development and Independent Validation of a Prognostic Gene Expression Signature Based on RB1, PTEN, and TP53 in Metastatic Hormone-sensitive Prostate Cancer Patients. Eur Urol Oncol. 2024 Aug;7(4):954-964. doi: 10.1016/j.euo.2023.12.012. Epub 2024 Mar 1.

    PubMed 38429210

  • 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.

    PubMed 34007017

  • 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.

    PubMed 32313142

  • 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.

    PubMed 29522362

  • 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.

    PubMed 29384722

  • 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.

    PubMed 29261442

  • 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.

    PubMed 28159490

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing androgen-deprivation therapy and docetaxel in people with Metastatic Hormone-sensitive Prostate Cancer, run by ECOG-ACRIN Cancer Research Group at 343 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 343 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00309985, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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