Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

May 31, 2028

Conditions
Prostate Carcinoma
Interventions
DRUG

Darolutamide

Given PO

DRUG

Goserelin Acetate

Given via injection

DRUG

Leuprolide Acetate

Given IV

DRUG

Placebo Administration

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Triptorelin

Given via injection

Trial Locations (115)

10461

Montefiore Medical Center-Einstein Campus, The Bronx

17822

Geisinger Medical Center, Danville

18711

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre

19611

Reading Hospital, West Reading

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

27012

Wake Forest University at Clemmons, Clemmons

27157

Wake Forest University Health Sciences, Winston-Salem

29401

Ralph H Johnson VA Medical Center, Charleston

29425

Medical University of South Carolina, Charleston

33140

Mount Sinai Medical Center, Miami Beach

33324

GenesisCare USA - Plantation, Plantation

34202

GenesisCare USA - Lakewood Ranch, Lakewood Rch

43614

University of Toledo, Toledo

43701

Genesis Healthcare System Cancer Care Center, Zanesville

45069

University of Cincinnati Cancer Center-West Chester, West Chester

45219

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati

46202

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis

48044

GenesisCare USA - Macomb, Macomb

48071

GenesisCare USA - Madison Heights, Madison Heights

48073

William Beaumont Hospital-Royal Oak, Royal Oak

48085

William Beaumont Hospital - Troy, Troy

48098

GenesisCare USA - Troy, Troy

48334

GenesisCare USA - Farmington Hills, Farmington Hills

48346

GenesisCare USA - Clarkston, Clarkston

50309

Iowa Methodist Medical Center, Des Moines

Medical Oncology and Hematology Associates-Des Moines, Des Moines

50314

Broadlawns Medical Center, Des Moines

Mission Cancer and Blood - Laurel, Des Moines

50316

Iowa Lutheran Hospital, Des Moines

50325

Medical Oncology and Hematology Associates-West Des Moines, Clive

53705

William S Middleton VA Medical Center, Madison

53792

University of Wisconsin Carbone Cancer Center, Madison

54449

Marshfield Medical Center-Marshfield, Marshfield

54476

Marshfield Medical Center - Weston, Weston

54482

Marshfield Medical Center-River Region at Stevens Point, Stevens Point

54548

Marshfield Clinic-Minocqua Center, Minocqua

54701

Marshfield Medical Center-EC Cancer Center, Eau Claire

54868

Marshfield Medical Center-Rice Lake, Rice Lake

55101

Regions Hospital, Saint Paul

55109

Minnesota Oncology Hematology PA-Maplewood, Maplewood

55432

Unity Hospital, Fridley

58122

Sanford Broadway Medical Center, Fargo

Sanford Roger Maris Cancer Center, Fargo

58501

Sanford Bismarck Medical Center, Bismarck

59405

Benefis Healthcare- Sletten Cancer Institute, Great Falls

59715

Bozeman Deaconess Hospital, Bozeman

60026

NorthShore University HealthSystem-Glenbrook Hospital, Glenview

60035

NorthShore University HealthSystem-Highland Park Hospital, Highland Park

60045

Northwestern Medicine Lake Forest Hospital, Lake Forest

60126

Elmhurst Memorial Hospital, Elmhurst

60201

NorthShore University HealthSystem-Evanston Hospital, Evanston

60451

UC Comprehensive Cancer Center at Silver Cross, New Lenox

60504

Rush - Copley Medical Center, Aurora

60540

Edward Hospital/Cancer Center, Naperville

60611

Northwestern University, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61350

Illinois CancerCare-Ottawa Clinic, Ottawa

61354

Illinois CancerCare-Peru, Peru

61356

Illinois CancerCare-Princeton, Princeton

61401

Illinois CancerCare-Galesburg, Galesburg

61443

Illinois CancerCare-Kewanee Clinic, Kewanee

61455

Illinois CancerCare-Macomb, Macomb

61520

Illinois CancerCare-Canton, Canton

61530

Illinois CancerCare-Eureka, Eureka

61554

Illinois CancerCare-Pekin, Pekin

61571

Illinois CancerCare - Washington, Washington

61615

Illinois CancerCare-Peoria, Peoria

61636

Methodist Medical Center of Illinois, Peoria

61704

Illinois CancerCare-Bloomington, Bloomington

61801

Carle Cancer Center, Urbana

The Carle Foundation Hospital, Urbana

61832

Carle on Vermilion, Danville

61938

Carle Physician Group-Mattoon/Charleston, Mattoon

62321

Illinois CancerCare-Carthage, Carthage

62401

Carle Physician Group-Effingham, Effingham

Crossroads Cancer Center, Effingham

62526

Cancer Care Specialists of Illinois - Decatur, Decatur

Decatur Memorial Hospital, Decatur

62702

Southern Illinois University School of Medicine, Springfield

Springfield Clinic, Springfield

62781

Memorial Medical Center, Springfield

63141

Mercy Hospital Saint Louis, St Louis

63703

Saint Francis Medical Center, Cape Girardeau

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75080

UT Southwestern Clinical Center at Richardson/Plano, Richardson

75235

Parkland Memorial Hospital, Dallas

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76104

UT Southwestern/Simmons Cancer Center-Fort Worth, Fort Worth

78229

Audie L Murphy VA Hospital, San Antonio

University of Texas Health Science Center at San Antonio, San Antonio

90033

Los Angeles County-USC Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

91010

City of Hope Comprehensive Cancer Center, Duarte

91030

City of Hope South Pasadena, South Pasadena

91786

City of Hope Upland, Upland

94304

Stanford Cancer Institute Palo Alto, Palo Alto

VA Palo Alto Health Care System, Palo Alto

96701

Pali Momi Medical Center, ‘Aiea

96813

Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu

Queen's Cancer Cenrer - POB I, Honolulu

Queen's Medical Center, Honolulu

Straub Clinic and Hospital, Honolulu

96817

Queen's Cancer Center - Kuakini, Honolulu

The Cancer Center of Hawaii-Liliha, Honolulu

06102

Hartford Hospital, Hartford

50266-7700

Methodist West Hospital, West Des Moines

01915

Beverly Hospital, Beverly

01805

Lahey Hospital and Medical Center, Burlington

01930

Addison Gilbert Hospital, Gloucester

01960

Lahey Medical Center-Peabody, Peabody

01890

Winchester Hospital, Winchester

03301

New Hampshire Oncology Hematology PA-Concord, Concord

03103

Solinsky Center for Cancer Care, Manchester

17033-0850

Penn State Milton S Hershey Medical Center, Hershey

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

ECOG-ACRIN Cancer Research Group

NETWORK