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

• ClinicalTrials.gov Identifier: NCT00309985
• Recruitment Status: Active, not recruiting
• First Posted: April 3, 2006
• Results First Posted: March 3, 2016
• Last Update Posted: September 24, 2019
• Sponsor: ECOG-ACRIN Cancer Research Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Metastatic Hormone-sensitive Prostate Cancer	Drug: androgen-deprivation therapy; Drug: docetaxel	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 790 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
• Study Start Date: July 28, 2006
• Actual Primary Completion Date: December 23, 2013
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 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.; Drug: docetaxel; Given IV; Other Names: Taxotere; RP 56976; NSC #628503
Active Comparator: Androgen-Deprivation Therapy alone; Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration) alone.	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.

Secondary Outcome Measures :

1. Time to Clinical Progression [ 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 ]
   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.
2. Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease) [ 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 ]
   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.
3. Proportion of Patients With PSA Complete Response (CR) at 6 Months [ Time Frame: Assessed 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.
4. Proportion of Patients With PSA Complete Response (CR) at 12 Months [ Time Frame: Assessed 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.
5. QOL Change From Baseline to 3 Months [ Time Frame: Assessed at baseline and 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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
• 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:

• 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:

  • 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

Contacts and Locations

Locations

United States, Alaska

Providence Cancer Center

Anchorage, Alaska, United States, 99508

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, United States, 99701

United States, Arizona

Mayo Clinic Hospital

Phoenix, Arizona, United States, 85054

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States, 85259-5499

United States, Arkansas

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, United States, 72903

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

United States, California

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States, 94704

Peninsula Medical Center

Burlingame, California, United States, 94010

California Cancer Care, Incorporated - Greenbrae

Greenbrae, California, United States, 94904

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States, 90089-9181

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, United States, 95901

Mather Veteran Affairs Medical Center

Mather, California, United States, 95655

Mercy Cancer Center at Mercy Medical Center

Merced, California, United States, 95340

Memorial Medical Center

Modesto, California, United States, 95355

Sutter Health - Western Division Cancer Research Group

Novato, California, United States, 94945

University of California Davis Cancer Center

Sacramento, California, United States, 95817

Saint Helena Hospital

Saint Helena, California, United States, 94574

California Pacific Medical Center - California Campus

San Francisco, California, United States, 94118

Sutter Pacific Medical Foundation

Santa Rosa, California, United States, 95403

Tahoe Forest Cancer Center

Truckee, California, United States, 96161

Sutter Solano Medical Center

Vallejo, California, United States, 94589

United States, Colorado

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States, 80045

Veterans Affairs Medical Center - Denver

Denver, Colorado, United States, 80220

Shaw Regional Cancer Center

Edwards, Colorado, United States, 81632

Poudre Valley Hospital

Fort Collins, Colorado, United States, 80524

Front Range Cancer Specialists

Fort Collins, Colorado, United States, 80528

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

Grand Junction, Colorado, United States, 81502

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, United States, 81401

United States, Connecticut

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

Hartford, Connecticut, United States, 06105

Yale Cancer Center

New Haven, Connecticut, United States, 06520-8028

United States, District of Columbia

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

George Washington University Medical Center

Washington, District of Columbia, United States, 20037

United States, Florida

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States, 33308

University of Florida Shands Cancer Center

Gainesville, Florida, United States, 32610-0232

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States, 32224

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, United States, 33458

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States, 33140

United States, Georgia

Northeast Georgia Medical Center

Gainesville, Georgia, United States, 30501

United States, Idaho

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

Boise, Idaho, United States, 83712

Saint Luke's Mountain States Tumor Institute - Fruitland

Fruitland, Idaho, United States, 83619

Idaho Urologic Institute, PA

Meridian, Idaho, United States, 83642

Mountain States Tumor Institute - Meridian

Meridian, Idaho, United States, 83642

Saint Luke's Mountain States Tumor Institute

Nampa, Idaho, United States, 83686

Mountain States Tumor Institute at St. Luke's

Twin Falls, Idaho, United States, 83301

United States, Illinois

Rush-Copley Cancer Care Center

Aurora, Illinois, United States, 60504

Illinois CancerCare - Bloomington

Bloomington, Illinois, United States, 61701

Graham Hospital

Canton, Illinois, United States, 61520

Illinois CancerCare - Canton

Canton, Illinois, United States, 61520

Illinois CancerCare - Carthage

Carthage, Illinois, United States, 62321

Memorial Hospital

Carthage, Illinois, United States, 62321

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States, 60611-3013

Hematology and Oncology Associates

Chicago, Illinois, United States, 60611

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States, 62526

Eureka Community Hospital

Eureka, Illinois, United States, 61530

Illinois CancerCare - Eureka

Eureka, Illinois, United States, 61530

Evanston Hospital

Evanston, Illinois, United States, 60201-1781

St. Francis Hospital

Evanston, Illinois, United States, 60202

Galesburg Clinic, PC

Galesburg, Illinois, United States, 61401

Illinois CancerCare - Cottage

Galesburg, Illinois, United States, 61401

Illinois CancerCare - Havana

Havana, Illinois, United States, 62644

Kellogg Cancer Care Center

Highland Park, Illinois, United States, 60035

Veterans Affairs Medical Center - Hines

Hines, Illinois, United States, 60141

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States, 60521

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States, 60435

Provena St. Mary's Regional Cancer Center - Kankakee

Kankakee, Illinois, United States, 60901

Illinois CancerCare - Kewanee Clinic

Kewanee, Illinois, United States, 61443

La Grange Memorial Hospital

La Grange, Illinois, United States, 60525

North Shore Oncology and Hematology Associates, Limited - Libertyville

Libertyville, Illinois, United States, 60048

Illinois CancerCare - Macomb

Macomb, Illinois, United States, 61455

McDonough District Hospital

Macomb, Illinois, United States, 61455

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States, 60153

Illinois CancerCare - Monmouth

Monmouth, Illinois, United States, 61462

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States, 62864

Hematology Oncology Consultants - Naperville

Naperville, Illinois, United States, 60540

Cancer Care and Hematology Specialists of Chicagoland - Niles

Niles, Illinois, United States, 60714

BroMenn Regional Medical Center

Normal, Illinois, United States, 61761

Community Cancer Center

Normal, Illinois, United States, 61761

Illinois CancerCare - Community Cancer Center

Normal, Illinois, United States, 61761

Mid-Illinois Hematology-Oncology Associates at Community Cancer Center

Normal, Illinois, United States, 61761

Community Hospital of Ottawa

Ottawa, Illinois, United States, 61350

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States, 61350

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States, 61554

Illinois CancerCare - Pekin

Pekin, Illinois, United States, 61603

Proctor Hospital

Peoria, Illinois, United States, 61614

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States, 61615

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States, 61615

Methodist Medical Center of Illinois

Peoria, Illinois, United States, 61636

Illinois CancerCare - Peru

Peru, Illinois, United States, 61354

Illinois Valley Community Hospital

Peru, Illinois, United States, 61354

Illinois CancerCare - Princeton

Princeton, Illinois, United States, 61356

Hematology Oncology Associates - Skokie

Skokie, Illinois, United States, 60076

Illinois CancerCare - Spring Valley

Spring Valley, Illinois, United States, 61362

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States, 62781-0001

CCOP - Carle Cancer Center

Urbana, Illinois, United States, 61801

United States, Indiana

Elkhart Clinic, LLC

Elkhart, Indiana, United States, 46514-2098

Michiana Hematology-Oncology, PC - Elkhart

Elkhart, Indiana, United States, 46514

Elkhart General Hospital

Elkhart, Indiana, United States, 46515

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States, 46845

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States, 46202-5289

Veterans Affairs Medical Center - Indianapolis

Indianapolis, Indiana, United States, 46202

William N. Wishard Memorial Hospital

Indianapolis, Indiana, United States, 46202

Howard Community Hospital

Kokomo, Indiana, United States, 46904

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States, 46350

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States, 46360

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, United States, 46545-1470

Saint Joseph Regional Medical Center

Mishawaka, Indiana, United States, 46545-1470

Michiana Hematology Oncology PC - Plymouth

Plymouth, Indiana, United States, 46563

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States, 46601

Memorial Hospital of South Bend

South Bend, Indiana, United States, 46601

Michiana Hematology Oncology PC - La Porte

Westville, Indiana, United States, 46391

United States, Iowa

Medical Oncology and Hematology Associates - West Des Moines

Clive, Iowa, United States, 50325

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States, 50309

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, United States, 50309

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, United States, 50309

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, United States, 50314

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, United States, 50314

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, United States, 50316

Veterans Affairs Medical Center - Iowa City

Iowa City, Iowa, United States, 52246

McCreery Cancer Center at Ottumwa Regional

Ottumwa, Iowa, United States, 52501

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States, 51101

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States, 51102

St. Luke's Regional Medical Center

Sioux City, Iowa, United States, 51104

United States, Kansas

Hays Medical Center

Hays, Kansas, United States, 67601

Hutchinson Hospital Corporation

Hutchinson, Kansas, United States, 67502

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

Kansas City, Kansas, United States, 66160-7357

Mount Carmel Regional Cancer Center

Pittsburg, Kansas, United States, 66762

St. Francis Comprehensive Cancer Center

Topeka, Kansas, United States, 66606

United States, Kentucky

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, United States, 40536-0093

United States, Louisiana

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, United States, 70809

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States, 70112

Medical Center of Louisiana - New Orleans

New Orleans, Louisiana, United States, 70112

United States, Maryland

DeCesaris Cancer Institute at Anne Arundel Medical Center

Annapolis, Maryland, United States, 21401

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

Veterans Affairs Medical Center - Baltimore

Baltimore, Maryland, United States, 21201

Greater Baltimore Medical Center Cancer Center

Baltimore, Maryland, United States, 21204

St. Agnes Hospital Cancer Center

Baltimore, Maryland, United States, 21229

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States, 21231-2410

United States, Massachusetts

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

Boston, Massachusetts, United States, 02115

Boston University Cancer Research Center

Boston, Massachusetts, United States, 02118

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, United States, 01805

Newton-Wellesley Hospital

Newton, Massachusetts, United States, 02462

Jordan Hospital Club Cancer Center

Plymouth, Massachusetts, United States, 02360

Commonwealth Hematology-Oncology, PC - Quincy

Quincy, Massachusetts, United States, 02169

United States, Michigan

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States, 48106-0995

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States, 48106

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109-0942

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, United States, 48123-2500

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, United States, 49431

Genesys Hurley Cancer Institute

Flint, Michigan, United States, 48503

Hurley Medical Center

Flint, Michigan, United States, 48503

Genesys Regional Medical Center

Grand Blanc, Michigan, United States, 48439

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

Grosse Pointe Woods, Michigan, United States, 48236

Dickinson County Healthcare System

Iron Mountain, Michigan, United States, 49801

Foote Memorial Hospital

Jackson, Michigan, United States, 49201

Borgess Medical Center

Kalamazoo, Michigan, United States, 49001

West Michigan Cancer Center

Kalamazoo, Michigan, United States, 49007-3731

Bronson Methodist Hospital

Kalamazoo, Michigan, United States, 49007

Sparrow Regional Cancer Center

Lansing, Michigan, United States, 48912-1811

St. Mary Mercy Hospital

Livonia, Michigan, United States, 48154

St. Joseph Mercy Oakland

Pontiac, Michigan, United States, 48341-2985

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, United States, 48060

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, United States, 48601

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, United States, 49085

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, United States, 49085

St. John Macomb Hospital

Warren, Michigan, United States, 48093

United States, Minnesota

MeritCare Bemidji

Bemidji, Minnesota, United States, 56601

St. Joseph's Medical Center

Brainerd, Minnesota, United States, 56401

Fairview Ridges Hospital

Burnsville, Minnesota, United States, 55337

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, United States, 55433

Duluth Clinic Cancer Center - Duluth

Duluth, Minnesota, United States, 55805-1983

CCOP - Duluth

Duluth, Minnesota, United States, 55805

Miller - Dwan Medical Center

Duluth, Minnesota, United States, 55805

Fairview Southdale Hospital

Edina, Minnesota, United States, 55435

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, United States, 55432

Hutchinson Area Health Care

Hutchinson, Minnesota, United States, 55350

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, United States, 55109

Minnesota Oncology - Maplewood

Maplewood, Minnesota, United States, 55109

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, United States, 55415

New Ulm Medical Center

New Ulm, Minnesota, United States, 56073

Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, United States, 55422-2900

Mayo Clinic Cancer Center

Rochester, Minnesota, United States, 55905

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, United States, 56303

Coborn Cancer Center

Saint Cloud, Minnesota, United States, 56303

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States, 55416

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, United States, 55416

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, United States, 55101

United Hospital

Saint Paul, Minnesota, United States, 55102

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, United States, 55379

Lakeview Hospital

Stillwater, Minnesota, United States, 55082

Ridgeview Medical Center

Waconia, Minnesota, United States, 55387

Willmar Cancer Center at Rice Memorial Hospital

Willmar, Minnesota, United States, 56201

Minnesota Oncology - Woodbury

Woodbury, Minnesota, United States, 55125

United States, Mississippi

University of Mississippi Cancer Clinic

Jackson, Mississippi, United States, 39216

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, United States, 39581

United States, Missouri

Central Care Cancer Center at Carrie J. Babb Cancer Center

Bolivar, Missouri, United States, 65613

Skaggs Cancer Center at Skaggs Regional Medical Center

Branson, Missouri, United States, 65616

Saint Francis Medical Center

Cape Girardeau, Missouri, United States, 63703

Truman Medical Center - Hospital Hill

Kansas City, Missouri, United States, 64108

Midwest Hematology Oncology Group, Incorporated

Saint Louis, Missouri, United States, 63109

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Saint Louis, Missouri, United States, 63110

CCOP - St. Louis-Cape Girardeau

Saint Louis, Missouri, United States, 63141

David C. Pratt Cancer Center at St. John's Mercy

Saint Louis, Missouri, United States, 63141

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States, 65802

St. John's Regional Health Center

Springfield, Missouri, United States, 65804

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States, 65807

United States, Montana

CCOP - Montana Cancer Consortium

Billings, Montana, United States, 59101

St. Vincent Healthcare Cancer Care Services

Billings, Montana, United States, 59101

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, United States, 59102

Billings Clinic - Downtown

Billings, Montana, United States, 59107-7000

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States, 59715

St. James Healthcare Cancer Care

Butte, Montana, United States, 59701

Big Sky Oncology

Great Falls, Montana, United States, 59405-5309

Great Falls Clinic - Main Facility

Great Falls, Montana, United States, 59405

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, United States, 59405

St. Peter's Hospital

Helena, Montana, United States, 59601

Glacier Oncology, PLLC

Kalispell, Montana, United States, 59901

Kalispell Medical Oncology at KRMC

Kalispell, Montana, United States, 59901

Kalispell Regional Medical Center

Kalispell, Montana, United States, 59901

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, United States, 59807-7877

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

Missoula, Montana, United States, 59807

United States, Nevada

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States, 89106

Nevada Cancer Institute

Las Vegas, Nevada, United States, 89135

United States, New Jersey

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, United States, 07018-1095

Hunterdon Regional Cancer Center at Hunterdon Medical Center

Flemington, New Jersey, United States, 08822

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, United States, 08690

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, United States, 07960

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

New Brunswick, New Jersey, United States, 08903

Frederick R. and Betty M. Smith Cancer Treatment Center

Sparta, New Jersey, United States, 07871

Overlook Hospital

Summit, New Jersey, United States, 07901

United States, New York

Kings County Hospital Center

Brooklyn, New York, United States, 11203

SUNY Downstate Medical Center

Brooklyn, New York, United States, 11203

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263-0001

Tucker Center for Cancer Care at Orange Regional Medical Center

Middletown, New York, United States, 10940-4199

NYU Cancer Institute at New York University Medical Center

New York, New York, United States, 10016

SUNY Upstate Medical University Hospital

Syracuse, New York, United States, 13210

Dickstein Cancer Treatment Center at White Plains Hospital Center

White Plains, New York, United States, 10601

United States, North Carolina

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States, 27534

Pardee Memorial Hospital

Hendersonville, North Carolina, United States, 28791

Kinston Medical Specialists

Kinston, North Carolina, United States, 28501

United States, North Dakota

Medcenter One Hospital Cancer Care Center

Bismarck, North Dakota, United States, 58501

Mid Dakota Clinic, PC

Bismarck, North Dakota, United States, 58501

St. Alexius Medical Center Cancer Center

Bismarck, North Dakota, United States, 58502

MeritCare Broadway

Fargo, North Dakota, United States, 58102

CCOP - MeritCare Hospital

Fargo, North Dakota, United States, 58122

Roger Maris Cancer Center at MeritCare Hospital

Fargo, North Dakota, United States, 58122

United States, Ohio

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, United States, 44309-2090

Barberton Citizens Hospital

Barberton, Ohio, United States, 44203

Cleveland Clinic Beachwood Family Health and Surgery Center

Beachwood, Ohio, United States, 44122

Aultman Cancer Center at Aultman Hospital

Canton, Ohio, United States, 44710-1799

Adena Regional Medical Center

Chillicothe, Ohio, United States, 45601

Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44106-5065

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, United States, 44111

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States, 44195

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, United States, 43214-3998

CCOP - Columbus

Columbus, Ohio, United States, 43215

Grant Medical Center Cancer Care

Columbus, Ohio, United States, 43215

Zangmeister Center

Columbus, Ohio, United States, 43219

Mount Carmel Health - West Hospital

Columbus, Ohio, United States, 43222

Doctors Hospital at Ohio Health

Columbus, Ohio, United States, 43228

Grady Memorial Hospital

Delaware, Ohio, United States, 43015

Cleveland Clinic Cancer Center

Independence, Ohio, United States, 44131

Fairfield Medical Center

Lancaster, Ohio, United States, 43130

St. Rita's Medical Center

Lima, Ohio, United States, 45801

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, United States, 45750

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, United States, 44124

Knox Community Hospital

Mount Vernon, Ohio, United States, 43050

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, United States, 43055

Parma Community General Hospital

Parma, Ohio, United States, 44129

Southern Ohio Medical Center Cancer Center

Portsmouth, Ohio, United States, 45662

North Coast Cancer Care, Incorporated

Sandusky, Ohio, United States, 44870

Community Hospital of Springfield and Clark County

Springfield, Ohio, United States, 45505

Cleveland Clinic Foundation - Strongsville

Strongsville, Ohio, United States, 44136

Mount Carmel St. Ann's Cancer Center

Westerville, Ohio, United States, 43081

Cleveland Clinic - Wooster

Wooster, Ohio, United States, 44691

Genesis - Good Samaritan Hospital

Zanesville, Ohio, United States, 43701

United States, Oklahoma

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States, 73104

United States, Pennsylvania

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States, 19010

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, United States, 17822-0001

Delaware County Regional Cancer Center at Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, United States, 19026

Adams Cancer Center

Gettysburg, Pennsylvania, United States, 17325

Cherry Tree Cancer Center

Hanover, Pennsylvania, United States, 17331

Geisinger Hazleton Cancer Center

Hazleton, Pennsylvania, United States, 18201

Cancer Center of Paoli Memorial Hospital

Paoli, Pennsylvania, United States, 19301-1792

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States, 19107-5541

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States, 19111-2497

St. Joseph Medical Center

Reading, Pennsylvania, United States, 19605

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, United States, 19612-6052

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, United States, 16801

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States, 18711

CCOP - Main Line Health

Wynnewood, Pennsylvania, United States, 19096

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, United States, 19096

York Cancer Center at Apple Hill Medical Center

York, Pennsylvania, United States, 17405

United States, South Dakota

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

United States, Tennessee

MBCCOP - Meharry Medical College - Nashville

Nashville, Tennessee, United States, 37208-3599

United States, Texas

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, United States, 78209

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229-3900

Cancer Therapy and Research Center

San Antonio, Texas, United States, 78229

University Hospital - San Antonio

San Antonio, Texas, United States, 78229

United States, Virginia

University of Virginia Cancer Center

Charlottesville, Virginia, United States, 22908

Lynchburg Hematology-Oncology Clinic

Lynchburg, Virginia, United States, 24501

United States, Washington

Cascade Cancer Center at Evergreen Hospital Medical Center

Kirkland, Washington, United States, 98033

CCOP - Virginia Mason Research Center

Seattle, Washington, United States, 98101

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Pacific Medical Center

Seattle, Washington, United States, 98104

United States, West Virginia

West Virginia University Health Sciences Center - Charleston

Charleston, West Virginia, United States, 25304

United States, Wisconsin

Langlade Memorial Hospital

Antigo, Wisconsin, United States, 54409

Marshfield Clinic - Chippewa Center

Chippewa Falls, Wisconsin, United States, 54729

Marshfield Clinic Cancer Care at Regional Cancer Center

Eau Claire, Wisconsin, United States, 54701

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

Green Bay, Wisconsin, United States, 54301-3526

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

Green Bay, Wisconsin, United States, 54303

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States, 54303

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States, 54307-3508

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

Green Bay, Wisconsin, United States, 54311

UW Cancer Center Johnson Creek

Johnson Creek, Wisconsin, United States, 53038

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, United States, 54601

Dean Medical Center - Madison

Madison, Wisconsin, United States, 53717

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States, 53792-6164

Holy Family Memorial Medical Center Cancer Care Center

Manitowoc, Wisconsin, United States, 54221-1450

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, United States, 54143

Vince Lombardi Cancer Clinic - Marinette

Marinette, Wisconsin, United States, 54143

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States, 54449

Saint Joseph's Hospital

Marshfield, Wisconsin, United States, 54449

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States, 53226

Marshfield Clinic - Lakeland Center

Minocqua, Wisconsin, United States, 54548

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, United States, 54154

Ministry Medical Group at Saint Mary's Hospital

Rhinelander, Wisconsin, United States, 54501

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, United States, 54868

St. Nicholas Hospital

Sheboygan, Wisconsin, United States, 53081

Vince Lombardi Cancer Clinic - Sheboygan

Sheboygan, Wisconsin, United States, 53081

Marshfield Clinic at Saint Michael's Hospital

Stevens Point, Wisconsin, United States, 54481

Saint Michael's Hospital Cancer Center

Stevens Point, Wisconsin, United States, 54481

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, United States, 54235

Aurora Medical Center

Summit, Wisconsin, United States, 53066

Vince Lombardi Cancer Clinic - Two Rivers

Two Rivers, Wisconsin, United States, 54241

Marshfield Clinic - Wausau Center

Wausau, Wisconsin, United States, 54401

University of Wisconcin Cancer Center at Aspirus Wausau Hospital

Wausau, Wisconsin, United States, 54401

Oncology Alliance, SC - Milwaukee - West

Wauwatosa, Wisconsin, United States, 53226

Diagnostic and Treatment Center

Weston, Wisconsin, United States, 54476

Marshfield Clinic - Weston Center

Weston, Wisconsin, United States, 54476

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, United States, 54494

United States, Wyoming

Rocky Mountain Oncology

Casper, Wyoming, United States, 82609

Sponsors and Collaborators

ECOG-ACRIN Cancer Research Group

National Cancer Institute (NCI)

Investigators

• Study Chair: Christopher Sweeney, MBBS; Dana-Farber Cancer Institute

More Information

Additional Information:

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive. 

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: ECOG-ACRIN Cancer Research Group
• ClinicalTrials.gov Identifier: NCT00309985
• Other Study ID Numbers: E3805; E3805 ( Other Identifier: ECOG-ACRIN Cancer Research Group ); U10CA180794 ( U.S. NIH Grant/Contract )
• First Posted: April 3, 2006
• Results First Posted: March 3, 2016
• Last Update Posted: September 24, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):

metastatic hormone-sensitive prostate cancer; docetaxel

Additional relevant MeSH terms:

Prostatic Neoplasms; Hypersensitivity; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Immune System Diseases; Ascorbic Acid; Docetaxel; Methyltestosterone; Hormones; Estrogens, Conjugated (USP); Androgens; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antioxidants; Protective Agents; Vitamins; Micronutrients; Nutrients; Growth Substances; Estrogens; Antineoplastic Agents, Hormonal