AzTrials
AzTrials

Recurrent Prostate CarcinomaPhase 2NCT03371719

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

A Phase 2 study testing Apalutamide and External Beam Radiation Therapy in people with Recurrent Prostate Carcinoma and Stage III Prostate Adenocarcinoma AJCC v7, run by NRG Oncology at 360 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with prostate cancer that has come back (recurrent). Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Apalutamide and External Beam Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
298 participants
Where
360 sitesin 2 countries
Study dates
20 Jun 2018to 10 Mar 2030
Phase
Phase 2

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

  • Pathologically (histologically) proven diagnosis of prostate adenocarcinoma; prostatectomy must have been performed within 10 years prior to Step 1 registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
  • Post-prostatectomy patients with a detectable serum PSA (>= 0.1, but =< 1.0 ng/mL) at study entry (within 90 days of Step 1 registration) and at least one of the following:
  • Gleason score 7-10 (International Society of Urological Pathology [ISUP] grade group 2 to 5)
  • ISUP grade group:
  • Grade group 1 = Gleason score =< 6,
  • Grade group 2 = Gleason score 3 + 4 = 7,
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  • Grade group 3 = Gleason score 4 + 3 = 7,
  • Grade group 4 = Gleason score 8,
  • Grade group 5 = Gleason scores 9 and 10
  • >= T3a disease
  • Persistent elevation of PSA after prostatectomy measured within 90 days after surgery (PSA never became undetectable) of > 0.04 but < 0.2 ng/mL (PSA nadir)
  • pN0 or pNx
  • History/physical examination within 90 days prior to Step 1 registration
  • Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
  • Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on Decipher GRID platform; Note: if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation and for GenomeDx to provide the subtyping needed for stratification
  • Prior androgen deprivation therapy (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to Step 1 registration and given for =< 90 days duration
  • For example: patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug; for instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date; for a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date
  • Please note: finasteride or dutasteride must be stopped before treatment starts but prior usage will not affect eligibility
  • Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to Step 1 registration
  • Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors within 90 days prior to Step 1 registration
  • Serum albumin >= 3.0 g/dL within 90 days prior to Step 1 registration
  • Glomerular filtration rate (GFR) >= 35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to Step 1 registration
  • Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (Note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible) within 90 days prior to Step 1 registration
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x ULN within 90 days prior to Step 1 registration
  • Testosterone > 50 ng/dL within 90 days prior to Step 1 registration
  • Concomitant medications known to lower the seizure threshold discontinued or substituted at least 4 weeks (30 days) prior to Step 1 registration
  • The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
  • The patient must agree not to donate sperm during the study treatment and for 3 months after receiving the last dose of study drug
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Who cannot join

  • PRIOR TO STEP 1 REGISTRATION:
  • Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)
  • Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • History of any of the following:
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  • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to Step 1 registration)
  • History of documented inflammatory bowel disease
  • Transmural myocardial infarction within the last 4 months prior to Step 1 registration
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to Step 1 registration
  • History of any condition that in the opinion of the investigator, would preclude participation in this study
  • Current evidence of any of the following:
  • Known gastrointestinal disorder affecting absorption of oral medications
  • Active uncontrolled infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis)
  • Uncontrolled hypertension
  • Any current condition that in the opinion of the investigator, would preclude participation in this study
  • Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is not allowed
  • HIV positive with CD4 count < 200 cells/microliter within 30 days prior to registration
  • HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count; (Note: HIV testing is not required for eligibility for this protocol as it is self-reported; this exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive and/or interact with HAART)
  • Patients must not plan to participate in any other clinical trials while receiving treatment on this study or being followed post-protocol therapy
  • PRIOR TO STEP 2 REGISTRATION:
  • For patients who have not undergone prior Decipher analysis, submission of the specimen to GenomeDx should be as soon as possible after study registration (Step 1) as these results can take up 21 days after the specimen is received at GenomeDx; Step 2 registration must occur within 6 weeks (42 days) of Step 1 registration; if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation

Trial locations and contacts

360 sites in 2 countries.

308 sites in 2 countries

United States300 sites

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • AdventHealth Altamonte

    Altamonte Springs, Florida, 32701

  • UPMC Altoona

    Altoona, Pennsylvania, 16601

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • MaineHealth Coastal Cancer Treatment Center

    Bath, Maine, 04530

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • MaineHealth Waldo Hospital

    Belfast, Maine, 04915

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Southwestern Vermont Medical Center

    Bennington, Vermont, 05201

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • MaineHealth Maine Medical Center - Biddeford

    Biddeford, Maine, 04005

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Sands Cancer Center

    Canandaigua, New York, 14424

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Michigan Healthcare Professionals Clarkston

    Clarkston, Michigan, 48346

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

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

    Clive, Iowa, 50325

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Michigan State University

    East Lansing, Michigan, 48823

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Farmington Health Center

    Farmington, Utah, 84025

  • Michigan Healthcare Professionals Farmington

    Farmington Hills, Michigan, 48334

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

  • Regional Cancer Center-Lee Memorial Health System

    Fort Myers, Florida, 33905

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • The West Clinic - Wolf River

    Germantown, Tennessee, 38138

  • Arizona Center for Cancer Care - Gilbert

    Gilbert, Arizona, 85297

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Marin General Hospital

    Greenbrae, California, 94904

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • Oncology Las Vegas - Henderson

    Henderson, Nevada, 89074

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • The Radiation Oncology Center-Hilton Head/Bluffton

    Hilton Head Island, South Carolina, 29926

  • Edward Hines Jr VA Hospital

    Hines, Illinois, 60141

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

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

    Johnstown, Pennsylvania, 15901

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • First Dayton Cancer Care

    Kettering, Ohio, 45420

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • AdventHealth Kissimmee

    Kissimmee, Florida, 34744

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Desert West Surgery

    Las Vegas, Nevada, 89102

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • Cancer Therapy and Integrative Medicine

    Las Vegas, Nevada, 89121

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

  • Oncology Las Vegas - Tenaya

    Las Vegas, Nevada, 89128

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

    Las Vegas, Nevada, 89149

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • University Cancer Center

    Las Vegas, Nevada, 89169

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Solinsky Center for Cancer Care

    Manchester, New Hampshire, 03103

  • Mayo Clinic Health Systems-Mankato

    Mankato, Minnesota, 56001

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • UPMC Cancer Center at UPMC McKeesport

    McKeesport, Pennsylvania, 15132

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    Metairie, Louisiana, 70006

  • UH Seidman Cancer Center at Southwest General Hospital

    Middleburg Heights, Ohio, 44130

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Zablocki Veterans Administration Medical Center

    Milwaukee, Wisconsin, 53295

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • UPMC Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • UPMC Hillman Cancer Center in Coraopolis

    Moon Township, Pennsylvania, 15108

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120

  • MaineHealth Stephens Hospital

    Norway, Maine, 04268

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • The University of Kansas Cancer Center - Olathe

    Olathe, Kansas, 66061

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • AdventHealth East Orlando

    Orlando, Florida, 32822

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Hope Cancer Care of Nevada-Pahrump

    Pahrump, Nevada, 89048

  • Camden Clark Medical Center

    Parkersburg, West Virginia, 26101

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

  • Arizona Center for Cancer Care-Peoria

    Peoria, Arizona, 85381

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Jefferson Torresdale Hospital

    Philadelphia, Pennsylvania, 19114

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

  • MaineHealth Maine Medical Center - Portland

    Portland, Maine, 04102

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Naval Medical Center - Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • University Hospitals Portage Medical Center

    Ravenna, Ohio, 44266

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Radiation Oncology Associates

    Reno, Nevada, 89509

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • Reid Health

    Richmond, Indiana, 47374

  • Hunter Holmes McGuire Veterans Administration Medical Center

    Richmond, Virginia, 23249

  • Riverton Hospital

    Riverton, Utah, 84065

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Wilmot Cancer Institute Radiation Oncology at Greece

    Rochester, New York, 14606

  • Highland Hospital

    Rochester, New York, 14620

  • University of Rochester

    Rochester, New York, 14642

  • Penobscot Bay Medical Center

    Rockport, Maine, 04856

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Dartmouth Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Audie L Murphy VA Hospital

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • UH Seidman Cancer Center at Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • MaineHealth Cancer Care and IV Therapy - Sanford

    Sanford, Maine, 04073

  • MaineHealth Cancer Care Center of York County

    Sanford, Maine, 04073

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

    Savannah, Georgia, 31405

  • Guthrie Medical Group PC-Robert Packer Hospital

    Sayre, Pennsylvania, 18840

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

  • Arizona Center for Cancer Care - Scottsdale

    Scottsdale, Arizona, 85258

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Sidney Kimmel Cancer Center Washington Township

    Sewell, New Jersey, 08080

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876

  • MaineHealth Cancer Care and IV Therapy - South Portland

    South Portland, Maine, 04106

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

Other trials in United States

Canada8 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • CIUSSSEMTL-Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

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

    Montreal, Quebec, H3H 2R9

  • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-Androgen Therapy With Apalutamide in Recurrent Prostate Cancer (BALANCE*)

This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with prostate cancer that has come back (recurrent). Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer compared to radiation therapy alone.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine whether, in men with post-prostatectomy prostate-specific antigen (PSA) recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.

SECONDARY OBJECTIVES:

  1. To assess whether molecular stratification by the PAM50 gene expression clustering will identify subsets of prostate cancer (luminal A or basal, luminal B) which derive the greatest benefit from anti-androgen therapy.

II. To assess overall survival. III. To assess cancer-specific mortality. IV. To assess metastasis-free survival. V. To assess distant metastasis. VI. To assess local-regional progression. VII. To assess PSA nadir during first year of treatment and prior to initiation of any hormonal salvage therapy.

VIII. To assess initiation of salvage hormonal therapy. IX. To assess PSA with a non-castrate testosterone at 1 and 3 years post randomization: PSA < 0.1 ng/ml and testosterone >= 50 ng/dl.

  1. To assess acute and late physician-reported morbidity (per the Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) after SRT +/- apalutamide.

XI. To assess acute and late patient-reported symptomatic adverse events morbidity (per the patient reported outcomes [PRO]-CTCAE) after SRT +/- apalutamide.

XII. To assess testosterone levels at 3, 6, 9, 12, and 36 months post randomization.

EXPLORATORY OBJECTIVE:

  1. To assess the prognostic and predictive value of the genomic classifier Decipher.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive placebo orally (PO) once daily (QD) on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive apalutamide PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly thereafter.

Being tested
Apalutamide, External Beam Radiation Therapy, Placebo Administration
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • ApalutamideDrug

    Also called ARN 509, ARN-509, ARN509, Erleada

    Given PO

  • External Beam Radiation TherapyRadiation

    Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy

    Undergo external beam radiation therapy

  • Placebo AdministrationOther

    Given PO

Study groups in NCT03371719
Study groupRoleWhat they receive
Arm 1 (radiation therapy, placebo)Active comparatorPatients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive placebo PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: External Beam Radiation Therapy; Other: Placebo Administration
Arm 2 (radiation therapy, apalutamide)ExperimentalPatients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive apalutamide PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Apalutamide; Radiation: External Beam Radiation Therapy

What is being measured

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

  1. Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)

    Biochemical progression is defined as the first occurrence of the following:

    • A rise in PSA ≥0.2 ng/mL from nadir PSA, confirmed by a second PSA measurement equal to or higher than the first;
    • Clinical or radiographic local, regional, or distant metastases
    • Death from any cause. Biochemical progression-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. Arms are compared within molecular subtype group sequentially based on a study design that determines if and how to incorporate the biomarker in a in a subsequent phase III trial.

    Measured: From randomization to biochemical progression or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.

Secondary outcomes (13)

  1. Percentage of Participants Alive (Overall Survival)

    Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

    Measured: From randomization to death or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.

  2. Percentage of Participants Who Have Died Due to Prostate Cancer (Cancer-specific Mortality (CSM))

    Prostate cancer death rates were estimated using the cumulative incidence method in which death from other causes is treated as a competing risk and alive patients are censored.

    Measured: From the date of randomization to the date of death due to prostate cancer or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.

  3. Percentage of Participants Alive Without Distant Metastases (Metastasis-free Survival (MFS))

    Distant metastases are defined as clinical or radiographic appearance of disseminated disease. MFS rates are estimated using the Kaplan-Meier method, censoring participants alive without metastases at time of analysis.

    Measured: From randomization to date of first distant metastasis or death, or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.

  4. Percentage of Participants With Distant Metastasis

    Distant metastases are defined as clinical or radiographic appearance of disseminated disease. Distant metastasis rates are estimated using the cumulative incidence method in which death is treated as competing risk and participants alive without distant metastases are censored at last known follow-up.

    Measured: From randomization to date of first distant metastasis or death, or last follow-up if alive at time of analysis. Median follow-up at time of analysis was 5.0 years. Five-year rates are presented.

  5. Percentage of Participants Wtih Local-regional Progression

    Local-regional progression is defined as recurrence within the pelvis including lymph nodes below the iliac bifurcation. Local-regional progression rates are estimated using the cumulative incidence method in which death is treated as competing risk and participants alive without local-regional progression are censored at last known follow-up.

    Measured: From randomization to date of first local or regional recurrence or death, or last follow-up if alive at time of analysis. Median follow-up at time of analysis was 5.0 years. Five-year rates are presented.

  6. PSA Nadir During First Year of Treatment and Prior to Initiation of Any Hormonal Salvage Therapy

    Will be compared between the two groups using a two-sample t-test.

    Measured: First year of treatment

  7. Percentage of Participants That Started Salvage Hormonal Therapy

    Initiation of salvage hormone therapy (LHRH analogues or non-study anti-androgens) that occurs after completion of SRT. Salvage hormonal therapy rates are estimated using the cumulative incidence method in which death is treated as competing risk and participants alive who have not started salvage hormonal therapy are censored at last known follow-up.

    Measured: From randomization to initiation of salvage hormonal therapy or death, whichever occurs first, or last follow-up if alive at time of analysis. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.

  8. Proportion of Participants With Undetectable PSA (< 0.1) and Non-castrate Testosterone (≥ 50 ng/dl) at One and Three Years

    Measured: One and three years

  9. Number of Participants With Grade 3+ Adverse Events Occurring Within 30 Days After the Completion of RT

    National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Measured: Up to 30 days after radiation therapy, which lasts approximately 7-8 weeks from treatment start.

  10. Number of Participants With Grade 3+ Adverse Events Occurring More Than 30 Days After the Completion of Radiation Therapy

    National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Measured: From the end of radiation therapy (approximately 7-8 weeks from treatment start) to last follow-up. Median follow-up at time of analysis among surviving patients was 5.0 years.

  11. Testosterone Levels

    Testosterone levels will be reported at this time points.

    Measured: 3, 6, 9, and 12 months

  12. Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) Occurring Within 30 Days After the Completion of RT

    PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values < 0.05.

    Measured: Up to 5 years

  13. Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) Occurring More Thant 30 Days After the Completion of RT

    PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values < 0.05.

    Measured: From the end of radiation therapy (approximately 7-8 weeks from treatment start) to two years.

Timeline

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

  1. First posted13 Dec 2017
  2. Study start20 Jun 2018
  3. Primary completion10 Mar 2025
  4. Study completion10 Mar 2030 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03371719
Sponsor's protocol ID
NRG-GU006
Other IDs
NCI-2017-01268, NRG-GU006, NRG-GU006, U10CA180868
Status last verified
Apr 2026
First submitted
8 Dec 2017
Last updated
1 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Publications

  • Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part III: Salvage Therapy After Radiotherapy or Focal Therapy, Pelvic Nodal Recurrence and Oligometastasis, and Future Directions. J Urol. 2024 Apr;211(4):526-532. doi: 10.1097/JU.0000000000003890. Epub 2024 Feb 29.

    PubMed 38421252

  • Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.

    PubMed 38421243

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