Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

324

Participants

Timeline

Start Date

June 20, 2018

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2026

Conditions
Recurrent Prostate CarcinomaStage III Prostate Adenocarcinoma AJCC v7Stage IV Prostate Adenocarcinoma AJCC v7
Interventions
DRUG

Apalutamide

Given PO

RADIATION

External Beam Radiation Therapy

Undergo external beam radiation therapy

OTHER

Placebo Administration

Given PO

Trial Locations (362)

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10468

James J Peters VA Medical Center, The Bronx

11215

New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn

11794

Stony Brook University Medical Center, Stony Brook

13210

State University of New York Upstate Medical University, Syracuse

13326

Mary Imogene Bassett Hospital, Cooperstown

14424

Sands Cancer Center, Canandaigua

14606

Wilmot Cancer Institute Radiation Oncology at Greece, Rochester

14620

Highland Hospital, Rochester

14642

University of Rochester, Rochester

15009

UPMC-Heritage Valley Health System Beaver, Beaver

15108

UPMC Hillman Cancer Center in Coraopolis, Moon Township

15132

UPMC Cancer Center at UPMC McKeesport, McKeesport

15146

UPMC Cancer Center - Monroeville, Monroeville

15213

UPMC-Magee Womens Hospital, Pittsburgh

15215

UPMC-Saint Margaret, Pittsburgh

15232

UPMC-Shadyside Hospital, Pittsburgh

15237

UPMC-Passavant Hospital, Pittsburgh

15243

UPMC-Saint Clair Hospital Cancer Center, Pittsburgh

15301

UPMC Washington Hospital Radiation Oncology, Washington

15401

UPMC Uniontown Hospital Radiation Oncology, Uniontown

15601

UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg

15901

UPMC-Johnstown/John P. Murtha Regional Cancer Center, Johnstown

16121

UPMC Cancer Center at UPMC Horizon, Farrell

16346

UPMC Cancer Center at UPMC Northwest, Seneca

16601

UPMC Altoona, Altoona

17109

UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg

18015

Saint Luke's University Hospital-Bethlehem Campus, Bethlehem

18512

Northeast Radiation Oncology Center, Dunmore

18840

Guthrie Medical Group PC-Robert Packer Hospital, Sayre

19090

Asplundh Cancer Pavilion, Willow Grove

19107

Thomas Jefferson University Hospital, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

19114

Jefferson Torresdale Hospital, Philadelphia

19317

Christiana Care Health System-Concord Health Center, Chadds Ford

19611

Reading Hospital, West Reading

19713

Helen F Graham Cancer Center, Newark

19718

Christiana Care Health System-Christiana Hospital, Newark

19971

Beebe Health Campus, Rehoboth Beach

20037

George Washington University Medical Center, Washington D.C.

21044

Central Maryland Radiation Oncology in Howard County, Columbia

21061

UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

21229

Saint Agnes Hospital, Baltimore

23249

Hunter Holmes McGuire Veterans Administration Medical Center, Richmond

26101

Camden Clark Medical Center, Parkersburg

26506

West Virginia University Healthcare, Morgantown

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

28401

Novant Health Cancer Institute Radiation Oncology - Wilmington, Wilmington

Novant Health New Hanover Regional Medical Center, Wilmington

28462

Novant Cancer Institute Radiation Oncology - Supply, Supply

29316

Prisma Health Cancer Institute - Spartanburg, Boiling Springs

29605

Prisma Health Cancer Institute - Faris, Greenville

29615

Prisma Health Cancer Institute - Eastside, Greenville

29646

Self Regional Healthcare, Greenwood

29650

Prisma Health Cancer Institute - Greer, Greer

29672

Prisma Health Cancer Institute - Seneca, Seneca

29926

The Radiation Oncology Center-Hilton Head/Bluffton, Hilton Head Island

30303

Grady Health System, Atlanta

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

30342

Emory Saint Joseph's Hospital, Atlanta

Northside Hospital, Atlanta

30912

Augusta University Medical Center, Augusta

31405

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah

32701

AdventHealth Altamonte, Altamonte Springs

32792

AdventHealth Winter Park, Winter Park

32803

AdventHealth Orlando, Orlando

32822

AdventHealth East Orlando, Orlando

33331

Cleveland Clinic-Weston, Weston

33905

Regional Cancer Center-Lee Memorial Health System, Fort Myers

34744

AdventHealth Kissimmee, Kissimmee

37232

Vanderbilt University/Ingram Cancer Center, Nashville

38138

The West Clinic - Wolf River, Germantown

39216

University of Mississippi Medical Center, Jackson

40536

University of Kentucky/Markey Cancer Center, Lexington

43210

Ohio State University Comprehensive Cancer Center, Columbus

43219

The Mark H Zangmeister Center, Columbus

44024

Geauga Hospital, Chardon

44060

UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor

44106

Case Western Reserve University, Cleveland

44111

Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland

44122

UHHS-Chagrin Highlands Medical Center, Beachwood

44124

Hillcrest Hospital Cancer Center, Mayfield Heights

44129

University Hospitals Parma Medical Center, Parma

44130

UH Seidman Cancer Center at Southwest General Hospital, Middleburg Heights

44136

Cleveland Clinic Cancer Center Strongsville, Strongsville

44145

UHHS-Westlake Medical Center, Westlake

44195

Cleveland Clinic Foundation, Cleveland

44266

University Hospitals Portage Medical Center, Ravenna

44304

Summa Health System - Akron Campus, Akron

44307

Cleveland Clinic Akron General, Akron

44691

Cleveland Clinic Wooster Family Health and Surgery Center, Wooster

44870

North Coast Cancer Care, Sandusky

UH Seidman Cancer Center at Firelands Regional Medical Center, Sandusky

44906

Cleveland Clinic Cancer Center Mansfield, Mansfield

45005

Dayton Physicians LLC-Atrium, Franklin

45069

University of Cincinnati Cancer Center-West Chester, West Chester

45219

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati

45236

Oncology Hematology Care Inc-Kenwood, Cincinnati

45331

Dayton Physicians LLC-Wayne, Greenville

Wayne Hospital, Greenville

45373

Dayton Physicians LLC - Troy, Troy

Upper Valley Medical Center, Troy

45406

Good Samaritan Hospital - Dayton, Dayton

45409

Miami Valley Hospital, Dayton

Greater Dayton Cancer Center, Kettering

45415

Dayton Physician LLC - Englewood, Dayton

Miami Valley Hospital North, Dayton

45420

First Dayton Cancer Care, Kettering

45429

Kettering Medical Center, Kettering

45431

Indu and Raj Soin Medical Center, Beavercreek

45459

Dayton Physicians LLC-Miami Valley South, Centerville

Miami Valley Hospital South, Centerville

45504

Springfield Regional Cancer Center, Springfield

Springfield Regional Medical Center, Springfield

45840

Armes Family Cancer Center, Findlay

Blanchard Valley Hospital, Findlay

Orion Cancer Care, Findlay

46526

Goshen Center for Cancer Care, Goshen

46805

Parkview Hospital Randallia, Fort Wayne

46845

Parkview Regional Medical Center, Fort Wayne

47374

Reid Health, Richmond

48038

Henry Ford Macomb Hospital-Clinton Township, Clinton Township

48073

Corewell Health William Beaumont University Hospital, Royal Oak

48085

Corewell Health Beaumont Troy Hospital, Troy

48098

Michigan Healthcare Professionals Troy, Troy

48106

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48114

Trinity Health Medical Center - Brighton, Brighton

48118

Chelsea Hospital, Chelsea

48124

Corewell Health Dearborn Hospital, Dearborn

48188

Trinity Health Medical Center - Canton, Canton

48202

Henry Ford Hospital, Detroit

48322

Henry Ford West Bloomfield Hospital, West Bloomfield

48334

Michigan Healthcare Professionals Farmington, Farmington Hills

48346

Michigan Healthcare Professionals Clarkston, Clarkston

48823

Michigan State University, East Lansing

48912

University of Michigan Health - Sparrow Lansing, Lansing

49007

West Michigan Cancer Center, Kalamazoo

49017

Bronson Battle Creek, Battle Creek

49085

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph

Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph

49120

Corewell Health Lakeland Hospitals - Niles Hospital, Niles

49503

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

Trinity Health Grand Rapids Hospital, Grand Rapids

49519

University of Michigan Health - West, Wyoming

49677

Corewell Health Reed City Hospital, Reed City

49684

Munson Medical Center, Traverse City

50266

Mercy Medical Center-West Lakes, West Des Moines

50314

Mercy Medical Center - Des Moines, Des Moines

UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines

50325

Mercy Cancer Center-West Lakes, Clive

UI Health Care Mission Cancer and Blood - West Des Moines Clinic, Clive

50801

Greater Regional Medical Center, Creston

53024

Aurora Cancer Care-Grafton, Grafton

53051

Froedtert Menomonee Falls Hospital, Menomonee Falls

53066

Aurora Medical Center in Summit, Summit

53081

Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan

53095

Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend

53142

Aurora Cancer Care-Kenosha South, Kenosha

53215

Aurora Saint Luke's Medical Center, Milwaukee

53226

Medical College of Wisconsin, Milwaukee

53227

Aurora West Allis Medical Center, West Allis

53295

Zablocki Veterans Administration Medical Center, Milwaukee

54017

Cancer Center of Western Wisconsin, New Richmond

54241

Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers

54311

Aurora BayCare Medical Center, Green Bay

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 Medical Center - Minocqua, Minocqua

54701

Marshfield Medical Center-EC Cancer Center, Eau Claire

54868

Marshfield Medical Center-Rice Lake, Rice Lake

54904

Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh

55082

Lakeview Hospital, Stillwater

55092

Fairview Lakes Medical Center, Wyoming

55101

Regions Hospital, Saint Paul

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology PA-Maplewood, Maplewood

Saint John's Hospital - Healtheast, Maplewood

55125

Minnesota Oncology Hematology PA-Woodbury, Woodbury

55337

Fairview Ridges Hospital, Burnsville

55362

Monticello Cancer Center, Monticello

55369

Fairview Clinics and Surgery Center Maple Grove, Maple Grove

55379

Saint Francis Regional Medical Center, Shakopee

55387

Ridgeview Medical Center, Waconia

55407

Abbott-Northwestern Hospital, Minneapolis

55415

Hennepin County Medical Center, Minneapolis

55416

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55417

Minneapolis VA Medical Center, Minneapolis

55422

North Memorial Medical Health Center, Robbinsdale

55432

Unity Hospital, Fridley

55433

Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

55454

Health Partners Inc, Minneapolis

55905

Mayo Clinic in Rochester, Rochester

56001

Mayo Clinic Health Systems-Mankato, Mankato

56007

Mayo Clinic Health System in Albert Lea, Albert Lea

56201

Rice Memorial Hospital, Willmar

56303

Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud

57701

Rapid City Regional Hospital, Rapid City

59101

Billings Clinic Cancer Center, Billings

59405

Benefis Sletten Cancer Institute, Great Falls

59715

Bozeman Health Deaconess Hospital, Bozeman

60141

Edward Hines Jr VA Hospital, Hines

60153

Loyola University Medical Center, Maywood

60612

Rush University Medical Center, Chicago

University of Illinois, Chicago

61615

Illinois CancerCare-Peoria, Peoria

OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria

61637

OSF Saint Francis Medical Center, Peoria

61801

Carle Cancer Center, Urbana

62401

Crossroads Cancer Center, Effingham

62526

Decatur Memorial Hospital, Decatur

62702

Southern Illinois University School of Medicine, Springfield

Springfield Clinic, Springfield

62781

Springfield Memorial Hospital, Springfield

63110

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center-South County, St Louis

63141

Siteman Cancer Center at West County Hospital, Creve Coeur

Mercy Hospital Saint Louis, St Louis

63376

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

63703

Mercy Cancer Center - Cape Girardeau, Cape Girardeau

64064

University of Kansas Cancer Center - Lee's Summit, Lee's Summit

64128

Kansas City Veterans Affairs Medical Center, Kansas City

64154

University of Kansas Cancer Center - North, Kansas City

65109

MU Health Care Goldschmidt Cancer Center, Jefferson City

65401

Phelps Health Delbert Day Cancer Institute, Rolla

66061

The University of Kansas Cancer Center - Olathe, Olathe

66160

University of Kansas Cancer Center, Kansas City

66205

University of Kansas Hospital-Westwood Cancer Center, Westwood

66210

University of Kansas Cancer Center-Overland Park, Overland Park

67401

Salina Regional Health Center, Salina

68114

Nebraska Methodist Hospital, Omaha

68124

Alegent Health Bergan Mercy Medical Center, Omaha

68198

University of Nebraska Medical Center, Omaha

70006

East Jefferson General Hospital, Metairie

LSU Healthcare Network / Metairie Multi-Specialty Clinic, Metairie

70809

Mary Bird Perkins Cancer Center, Baton Rouge

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74133

Cancer Treatment Centers of America, Tulsa

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

78229

Audie L Murphy VA Hospital, San Antonio

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

80045

UCHealth University of Colorado Hospital, Aurora

80524

Poudre Valley Hospital, Fort Collins

80528

Cancer Care and Hematology-Fort Collins, Fort Collins

80538

Medical Center of the Rockies, Loveland

80631

UCHealth Greeley Hospital, Greeley

80907

Penrose-Saint Francis Healthcare, Colorado Springs

80909

UCHealth Memorial Hospital Central, Colorado Springs

80920

Memorial Hospital North, Colorado Springs

81601

Valley View Hospital Cancer Center, Glenwood Springs

83301

Saint Luke's Cancer Institute - Twin Falls, Twin Falls

83619

Saint Luke's Cancer Institute - Fruitland, Fruitland

83642

Saint Luke's Cancer Institute - Meridian, Meridian

83687

Saint Luke's Cancer Institute - Nampa, Nampa

83712

Saint Luke's Cancer Institute - Boise, Boise

84003

American Fork Hospital / Huntsman Intermountain Cancer Center, American Fork

84025

Farmington Health Center, Farmington

84065

Riverton Hospital, Riverton

84106

Utah Cancer Specialists-Salt Lake City, Salt Lake City

84107

Intermountain Medical Center, Murray

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

84143

LDS Hospital, Salt Lake City

84321

Logan Regional Hospital, Logan

84403

McKay-Dee Hospital Center, Ogden

84604

Utah Valley Regional Medical Center, Provo

84720

Sandra L Maxwell Cancer Center, Cedar City

84770

Saint George Regional Medical Center, St. George

85258

Arizona Center for Cancer Care - Scottsdale, Scottsdale

85297

Arizona Center for Cancer Care - Gilbert, Gilbert

85374

Arizona Center for Cancer Care-Surprise, Surprise

85381

Arizona Center for Cancer Care-Peoria, Peoria

87106

University of New Mexico Cancer Center, Albuquerque

87109

New Mexico Oncology Hematology Consultants, Albuquerque

89048

Hope Cancer Care of Nevada-Pahrump, Pahrump

89052

Comprehensive Cancer Centers of Nevada - Henderson, Henderson

Comprehensive Cancer Centers of Nevada-Horizon Ridge, Henderson

Las Vegas Cancer Center-Henderson, Henderson

OptumCare Cancer Care at Seven Hills, Henderson

89074

Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson

GenesisCare USA - Henderson, Henderson

89102

Desert West Surgery, Las Vegas

OptumCare Cancer Care at Charleston, Las Vegas

University Medical Center of Southern Nevada, Las Vegas

89103

Hope Cancer Care of Nevada, Las Vegas

89106

Radiation Oncology Centers of Nevada Central, Las Vegas

89109

GenesisCare USA - Las Vegas, Las Vegas

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway, Las Vegas

89113

HealthCare Partners Medical Group Oncology/Hematology-San Martin, Las Vegas

89119

Radiation Oncology Centers of Nevada Southeast, Las Vegas

89121

Cancer Therapy and Integrative Medicine, Las Vegas

89128

Ann M Wierman MD LTD, Las Vegas

Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas

GenesisCare USA - Vegas Tenaya, Las Vegas

HealthCare Partners Medical Group Oncology/Hematology-Tenaya, Las Vegas

OptumCare Cancer Care at MountainView, Las Vegas

89144

Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas

Summerlin Hospital Medical Center, Las Vegas

89148

Comprehensive Cancer Centers of Nevada, Las Vegas

GenesisCare USA - Fort Apache, Las Vegas

OptumCare Cancer Care at Fort Apache, Las Vegas

89149

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills, Las Vegas

89169

Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas

University Cancer Center, Las Vegas

89509

Radiation Oncology Associates, Reno

90033

Los Angeles General Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

94589

Sutter Solano Medical Center/Cancer Center, Vallejo

94704

Alta Bates Summit Medical Center-Herrick Campus, Berkeley

94904

Marin General Hospital, Greenbrae

95661

Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville

95816

Sutter Medical Center Sacramento, Sacramento

95817

University of California Davis Comprehensive Cancer Center, Sacramento

96161

Gene Upshaw Memorial Tahoe Forest Cancer Center, Truckee

97030

Legacy Mount Hood Medical Center, Gresham

97210

Legacy Good Samaritan Hospital and Medical Center, Portland

98225

PeaceHealth Saint Joseph Medical Center, Bellingham

98686

Legacy Salmon Creek Hospital, Vancouver

99362

Providence Saint Mary Regional Cancer Center, Walla Walla

06904

Stamford Hospital/Bennett Cancer Center, Stamford

04530

MaineHealth Coastal Cancer Treatment Center, Bath

04915

MaineHealth Waldo Hospital, Belfast

04005

MaineHealth Maine Medical Center - Biddeford, Biddeford

04412

Lafayette Family Cancer Center-EMMC, Brewer

04268

MaineHealth Stephens Hospital, Norway

04102

MaineHealth Maine Medical Center - Portland, Portland

04856

Penobscot Bay Medical Center, Rockport

04073

MaineHealth Cancer Care and IV Therapy - Sanford, Sanford

MaineHealth Cancer Care Center of York County, Sanford

04074

MaineHealth Maine Medical Center- Scarborough, Scarborough

04106

MaineHealth Cancer Care and IV Therapy - South Portland, South Portland

01805

Lahey Hospital and Medical Center, Burlington

01854

Lowell General Hospital, Lowell

89148-2405

Las Vegas Cancer Center-Medical Center, Las Vegas

03301

New Hampshire Oncology Hematology PA-Concord, Concord

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

03103

Solinsky Center for Cancer Care, Manchester

08060

Virtua Memorial, Mount Holly

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

08080

Sidney Kimmel Cancer Center Washington Township, Sewell

08876

Robert Wood Johnson University Hospital Somerset, Somerville

45005-1066

Atrium Medical Center-Middletown Regional Hospital, Franklin

17033-0850

Penn State Milton S Hershey Medical Center, Hershey

05201

Southwestern Vermont Medical Center, Bennington

05602

Central Vermont Medical Center/National Life Cancer Treatment, Berlin Corners

05401

University of Vermont Medical Center, Burlington

05405

University of Vermont and State Agricultural College, Burlington

05819

Dartmouth Cancer Center - North, Saint Johnsbury

23708-2197

Naval Medical Center - Portsmouth, Portsmouth

T2N 5G2

Arthur J E Child Comprehensive Cancer Centre, Calgary

M5G 2M9

University Health Network-Princess Margaret Hospital, Toronto

H1T 2M4

CIUSSSEMTL-Hopital Maisonneuve-Rosemont, Montreal

H3H 2R9

The Research Institute of the McGill University Health Centre (MUHC), Montreal

G1R 2J6

CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ), Québec

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke

S4T 7T1

Allan Blair Cancer Centre, Regina

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

NRG Oncology

OTHER