Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

BIOMARKER-PRØVNING av APALUTAMIDE og STRÅLING for gjentakende prostatakreft (BALANCE)

6. august 2026 oppdatert av: NRG Oncology

En fase II, dobbeltblindet, placebokontrollert randomisert studie av redningsstrålebehandling med eller uten forbedret antiandrogenterapi med apalutamid ved tilbakevendende prostatakreft

Denne fase II-studien studerer hvor godt strålebehandling med eller uten apalutamid virker ved behandling av pasienter med stadium III-IV prostatakreft. Strålebehandling bruker høyenergi røntgen for å drepe tumorceller og krympe svulster. Androgen kan forårsake vekst av prostatakreftceller. Legemidler, som apalutamid, kan redusere mengden androgen som kroppen produserer. Å gi strålebehandling og apalutamid kan fungere bedre ved behandling av prostatakreft enn stråling alene.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PRIMÆRE MÅL:

I. For å bestemme om, hos menn med tilbakefall av PSA etter prostatektomi, vil bergingsstråling (SRT) med forsterket antiandrogenbehandling med apalutamid forbedre biokjemisk progresjonsfri overlevelse (bPFS) sammenlignet med SRT alene.

SEKUNDÆRE MÅL:

I. For å vurdere om molekylær stratifisering ved PAM50-genekspresjonsklynger vil identifisere undergrupper av prostatakreft (luminal A eller basal, luminal B) som får størst nytte av antiandrogenterapi.

II. For å vurdere total overlevelse. III. For å vurdere kreftspesifikk dødelighet. IV. For å vurdere metastasefri overlevelse. V. For å vurdere fjernmetastaser. VI. For å vurdere lokal-regional progresjon. VII. For å vurdere PSA-nadir i løpet av det første behandlingsåret og før oppstart av eventuell hormonbehandling.

VIII. For å vurdere initiering av salvage hormonbehandling. IX. For å vurdere PSA med et ikke-kastrat testosteron 1 og 3 år etter randomisering: PSA < 0,1 ng/ml og testosteron >= 50 ng/dl.

X. For å vurdere akutt og sent legerapportert sykelighet (i henhold til Common Terminology Criteria for Adverse Events [CTCAE] versjon 5) etter SRT +/- apalutamid.

XI. For å vurdere akutt og sent pasientrapportert sykelighet (i henhold til pasientrapporterte utfall [PRO]-CTCAE) etter SRT +/- apalutamid.

XII. For å vurdere testosteronnivåer 3, 6, 9, 12 og 36 måneder etter randomisering.

OVERSIGT: Pasienter randomiseres til 1 av 2 armer.

ARM 1: Pasienter gjennomgår ekstern strålebehandling på dag 1 i 7,5 uker. Fra og med dag 1 av strålebehandling får pasienter placebo oralt (PO) én gang daglig (QD) på dag 1-30. Behandlingen gjentas hver 30. dag i opptil 6 kurer (6 måneder) i fravær av sykdomsprogresjon eller uakseptabel toksisitet.

ARM 2: Pasienter gjennomgår ekstern strålebehandling på dag 1 i 7,5 uker. Fra og med dag 1 av strålebehandling får pasienter apalutamid PO QD på dag 1-30. Behandlingen gjentas hver 30. dag i opptil 6 kurer (6 måneder) i fravær av sykdomsprogresjon eller uakseptabel toksisitet.

Etter fullført studiebehandling følges pasientene opp hver 3. måned i 2 år, deretter hver 6. måned i 3 år, og deretter årlig.

Studietype

Intervensjonell

Registrering (Faktiske)

298

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • The Research Institute of the McGill University Health Centre (MUHC)
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSSEMTL-Hopital Maisonneuve-Rosemont
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Forente stater
    • Arizona
      • Gilbert, Arizona, Forente stater, 85297
        • Arizona Center for Cancer Care - Gilbert
      • Peoria, Arizona, Forente stater, 85381
        • Arizona Center for Cancer Care-Peoria
      • Scottsdale, Arizona, Forente stater, 85258
        • Arizona Center for Cancer Care - Scottsdale
      • Surprise, Arizona, Forente stater, 85374
        • Arizona Center for Cancer Care-Surprise
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Berkeley, California, Forente stater, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Greenbrae, California, Forente stater, 94904
        • Marin General Hospital
      • Los Angeles, California, Forente stater, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, Forente stater, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, Forente stater, 90033
        • Los Angeles General Medical Center
      • Roseville, California, Forente stater, 95661
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
      • Sacramento, California, Forente stater, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, Forente stater, 95817
        • University of California Davis Comprehensive Cancer Center
      • Truckee, California, Forente stater, 96161
        • Gene Upshaw Memorial Tahoe Forest Cancer Center
      • Vallejo, California, Forente stater, 94589
        • Sutter Solano Medical Center/Cancer Center
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • UCHealth University of Colorado Hospital
      • Colorado Springs, Colorado, Forente stater, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, Forente stater, 80909
        • UCHealth Memorial Hospital Central
      • Colorado Springs, Colorado, Forente stater, 80920
        • Memorial Hospital North
      • Fort Collins, Colorado, Forente stater, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, Forente stater, 80528
        • Cancer Care and Hematology-Fort Collins
      • Glenwood Springs, Colorado, Forente stater, 81601
        • Valley View Hospital Cancer Center
      • Greeley, Colorado, Forente stater, 80631
        • UCHealth Greeley Hospital
      • Loveland, Colorado, Forente stater, 80538
        • Medical Center of the Rockies
    • Connecticut
      • Stamford, Connecticut, Forente stater, 06904
        • Stamford Hospital/Bennett Cancer Center
    • Delaware
      • Newark, Delaware, Forente stater, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Forente stater, 19718
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, Forente stater, 19971
        • Beebe Health Campus
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20037
        • George Washington University Medical Center
    • Florida
      • Altamonte Springs, Florida, Forente stater, 32701
        • AdventHealth Altamonte
      • Fort Myers, Florida, Forente stater, 33905
        • Regional Cancer Center-Lee Memorial Health System
      • Kissimmee, Florida, Forente stater, 34744
        • AdventHealth Kissimmee
      • Orlando, Florida, Forente stater, 32803
        • AdventHealth Orlando
      • Orlando, Florida, Forente stater, 32822
        • AdventHealth East Orlando
      • Weston, Florida, Forente stater, 33331
        • Cleveland Clinic-Weston
      • Winter Park, Florida, Forente stater, 32792
        • AdventHealth Winter Park
    • Georgia
      • Atlanta, Georgia, Forente stater, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, Forente stater, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, Forente stater, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, Forente stater, 30303
        • Grady Health System
      • Atlanta, Georgia, Forente stater, 30342
        • Northside Hospital
      • Augusta, Georgia, Forente stater, 30912
        • Augusta University Medical Center
      • Savannah, Georgia, Forente stater, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Idaho
      • Boise, Idaho, Forente stater, 83712
        • Saint Luke's Cancer Institute - Boise
      • Fruitland, Idaho, Forente stater, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Forente stater, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Forente stater, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, Forente stater, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • University of Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Rush MD Anderson Cancer Center
      • Decatur, Illinois, Forente stater, 62526
        • Decatur Memorial Hospital
      • Effingham, Illinois, Forente stater, 62401
        • Crossroads Cancer Center
      • Hines, Illinois, Forente stater, 60141
        • Edward Hines Jr VA Hospital
      • Maywood, Illinois, Forente stater, 60153
        • Loyola University Medical Center
      • Peoria, Illinois, Forente stater, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, Forente stater, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, Forente stater, 61615
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
      • Springfield, Illinois, Forente stater, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, Forente stater, 62702
        • Springfield Clinic
      • Springfield, Illinois, Forente stater, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, Forente stater, 61801
        • Carle Cancer Center
    • Indiana
      • Fort Wayne, Indiana, Forente stater, 46805
        • Parkview Hospital Randallia
      • Fort Wayne, Indiana, Forente stater, 46845
        • Parkview Regional Medical Center
      • Goshen, Indiana, Forente stater, 46526
        • Goshen Center for Cancer Care
      • Richmond, Indiana, Forente stater, 47374
        • Reid Health
    • Iowa
      • Clive, Iowa, Forente stater, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Forente stater, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Creston, Iowa, Forente stater, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, Forente stater, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forente stater, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • West Des Moines, Iowa, Forente stater, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • University of Kansas Cancer Center
      • Olathe, Kansas, Forente stater, 66061
        • The University of Kansas Cancer Center - Olathe
      • Overland Park, Kansas, Forente stater, 66210
        • University of Kansas Cancer Center-Overland Park
      • Salina, Kansas, Forente stater, 67401
        • Salina Regional Health Center
      • Westwood, Kansas, Forente stater, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536
        • University of Kentucky/Markey Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70809
        • Mary Bird Perkins Cancer Center
      • Metairie, Louisiana, Forente stater, 70006
        • East Jefferson General Hospital
      • Metairie, Louisiana, Forente stater, 70006
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
    • Maine
      • Bath, Maine, Forente stater, 04530
        • MaineHealth Coastal Cancer Treatment Center
      • Belfast, Maine, Forente stater, 04915
        • MaineHealth Waldo Hospital
      • Biddeford, Maine, Forente stater, 04005
        • MaineHealth Maine Medical Center - Biddeford
      • Brewer, Maine, Forente stater, 04412
        • Lafayette Family Cancer Center-EMMC
      • Norway, Maine, Forente stater, 04268
        • MaineHealth Stephens Hospital
      • Portland, Maine, Forente stater, 04102
        • MaineHealth Maine Medical Center - Portland
      • Rockport, Maine, Forente stater, 04856
        • Penobscot Bay Medical Center
      • Sanford, Maine, Forente stater, 04073
        • MaineHealth Cancer Care Center of York County
      • Sanford, Maine, Forente stater, 04073
        • MaineHealth Cancer Care and IV Therapy - Sanford
      • Scarborough, Maine, Forente stater, 04074
        • MaineHealth Maine Medical Center- Scarborough
      • South Portland, Maine, Forente stater, 04106
        • MaineHealth Cancer Care and IV Therapy - South Portland
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Baltimore, Maryland, Forente stater, 21229
        • Saint Agnes Hospital
      • Columbia, Maryland, Forente stater, 21044
        • Central Maryland Radiation Oncology in Howard County
      • Glen Burnie, Maryland, Forente stater, 21061
        • UM Baltimore Washington Medical Center/Tate Cancer Center
    • Massachusetts
      • Burlington, Massachusetts, Forente stater, 01805
        • Lahey Hospital and Medical Center
      • Lowell, Massachusetts, Forente stater, 01854
        • Lowell General Hospital
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, Forente stater, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Battle Creek, Michigan, Forente stater, 49017
        • Bronson Battle Creek
      • Brighton, Michigan, Forente stater, 48114
        • Trinity Health Medical Center - Brighton
      • Canton, Michigan, Forente stater, 48188
        • Trinity Health Medical Center - Canton
      • Chelsea, Michigan, Forente stater, 48118
        • Chelsea Hospital
      • Clarkston, Michigan, Forente stater, 48346
        • Michigan Healthcare Professionals Clarkston
      • Clinton Township, Michigan, Forente stater, 48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn, Michigan, Forente stater, 48124
        • Corewell Health Dearborn Hospital
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Hospital
      • East Lansing, Michigan, Forente stater, 48823
        • Michigan State University
      • Farmington Hills, Michigan, Forente stater, 48334
        • Michigan Healthcare Professionals Farmington
      • Grand Rapids, Michigan, Forente stater, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, Forente stater, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Kalamazoo, Michigan, Forente stater, 49007
        • West Michigan Cancer Center
      • Lansing, Michigan, Forente stater, 48912
        • University of Michigan Health - Sparrow Lansing
      • Niles, Michigan, Forente stater, 49120
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Reed City, Michigan, Forente stater, 49677
        • Corewell Health Reed City Hospital
      • Royal Oak, Michigan, Forente stater, 48073
        • Corewell Health William Beaumont University Hospital
      • Saint Joseph, Michigan, Forente stater, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, Forente stater, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Traverse City, Michigan, Forente stater, 49684
        • Munson Medical Center
      • Troy, Michigan, Forente stater, 48098
        • Michigan Healthcare Professionals Troy
      • Troy, Michigan, Forente stater, 48085
        • Corewell Health Beaumont Troy Hospital
      • West Bloomfield, Michigan, Forente stater, 48322
        • Henry Ford West Bloomfield Hospital
      • Wyoming, Michigan, Forente stater, 49519
        • University of Michigan Health - West
    • Minnesota
      • Albert Lea, Minnesota, Forente stater, 56007
        • Mayo Clinic Health System in Albert Lea
      • Burnsville, Minnesota, Forente stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forente stater, 55433
        • Mercy Hospital
      • Edina, Minnesota, Forente stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forente stater, 55432
        • Unity Hospital
      • Mankato, Minnesota, Forente stater, 56001
        • Mayo Clinic Health Systems-Mankato
      • Maple Grove, Minnesota, Forente stater, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, Forente stater, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Forente stater, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Forente stater, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forente stater, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Forente stater, 55454
        • Health Partners Inc
      • Minneapolis, Minnesota, Forente stater, 55417
        • Minneapolis VA Medical Center
      • Monticello, Minnesota, Forente stater, 55362
        • Monticello Cancer Center
      • Robbinsdale, Minnesota, Forente stater, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic in Rochester
      • Saint Cloud, Minnesota, Forente stater, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Forente stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forente stater, 55102
        • United Hospital
      • Shakopee, Minnesota, Forente stater, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Forente stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forente stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forente stater, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Forente stater, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, Forente stater, 55092
        • Fairview Lakes Medical Center
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Cape Girardeau, Missouri, Forente stater, 63703
        • Mercy Cancer Center - Cape Girardeau
      • City of Saint Peters, Missouri, Forente stater, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, Forente stater, 63141
        • Siteman Cancer Center at West County Hospital
      • Jefferson City, Missouri, Forente stater, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Kansas City, Missouri, Forente stater, 64128
        • Kansas City Veterans Affairs Medical Center
      • Kansas City, Missouri, Forente stater, 64154
        • University of Kansas Cancer Center - North
      • Lee's Summit, Missouri, Forente stater, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • Rolla, Missouri, Forente stater, 65401
        • Phelps Health Delbert Day Cancer Institute
      • St Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Forente stater, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, Forente stater, 63141
        • Mercy Hospital Saint Louis
    • Montana
      • Billings, Montana, Forente stater, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, Forente stater, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, Forente stater, 59405
        • Benefis Sletten Cancer Institute
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Forente stater, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Forente stater, 68124
        • Alegent Health Bergan Mercy Medical Center
    • Nevada
      • Henderson, Nevada, Forente stater, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Forente stater, 89052
        • OptumCare Cancer Care at Seven Hills
      • Henderson, Nevada, Forente stater, 89052
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Forente stater, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Forente stater, 89052
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, Forente stater, 89074
        • Oncology Las Vegas - Henderson
      • Las Vegas, Nevada, Forente stater, 89144
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, Forente stater, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Forente stater, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Forente stater, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Forente stater, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Forente stater, 89128
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, Forente stater, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Forente stater, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forente stater, 89148
        • OptumCare Cancer Care at Fort Apache
      • Las Vegas, Nevada, Forente stater, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Forente stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forente stater, 89109
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Forente stater, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Forente stater, 89121
        • Cancer Therapy and Integrative Medicine
      • Las Vegas, Nevada, Forente stater, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Forente stater, 89148-2405
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Forente stater, 89149
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, Forente stater, 89128
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, Forente stater, 89102
        • Desert West Surgery
      • Las Vegas, Nevada, Forente stater, 89103
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, Forente stater, 89169
        • University Cancer Center
      • Las Vegas, Nevada, Forente stater, 89128
        • Oncology Las Vegas - Tenaya
      • Pahrump, Nevada, Forente stater, 89048
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, Forente stater, 89509
        • Radiation Oncology Associates
    • New Hampshire
      • Concord, New Hampshire, Forente stater, 03301
        • New Hampshire Oncology Hematology PA-Concord
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
      • Manchester, New Hampshire, Forente stater, 03103
        • Solinsky Center for Cancer Care
    • New Jersey
      • Mount Holly, New Jersey, Forente stater, 08060
        • Virtua Memorial
      • New Brunswick, New Jersey, Forente stater, 08903
        • Rutgers Cancer Institute of New Jersey
      • Sewell, New Jersey, Forente stater, 08080
        • Sidney Kimmel Cancer Center Washington Township
      • Somerville, New Jersey, Forente stater, 08876
        • Robert Wood Johnson University Hospital Somerset
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87109
        • New Mexico Oncology Hematology Consultants
      • Albuquerque, New Mexico, Forente stater, 87106
        • University of New Mexico Cancer Center
    • New York
      • Brooklyn, New York, Forente stater, 11215
        • New York-Presbyterian/Brooklyn Methodist Hospital
      • Canandiaqua, New York, Forente stater, 14424
        • Sands Cancer Center
      • Cooperstown, New York, Forente stater, 13326
        • Mary Imogene Bassett Hospital
      • New York, New York, Forente stater, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Rochester, New York, Forente stater, 14642
        • University of Rochester
      • Rochester, New York, Forente stater, 14620
        • Highland Hospital
      • Rochester, New York, Forente stater, 14606
        • Wilmot Cancer Institute Radiation Oncology at Greece
      • Stony Brook, New York, Forente stater, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, Forente stater, 13210
        • State University of New York Upstate Medical University
      • The Bronx, New York, Forente stater, 10468
        • James J Peters VA Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Supply, North Carolina, Forente stater, 28462
        • Novant Cancer Institute Radiation Oncology - Supply
      • Wilmington, North Carolina, Forente stater, 28401
        • Novant Health New Hanover Regional Medical Center
      • Wilmington, North Carolina, Forente stater, 28401
        • Novant Health Cancer Institute Radiation Oncology - Wilmington
    • Ohio
      • Akron, Ohio, Forente stater, 44307
        • Cleveland Clinic Akron General
      • Akron, Ohio, Forente stater, 44304
        • Summa Health System - Akron Campus
      • Beachwood, Ohio, Forente stater, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Beavercreek, Ohio, Forente stater, 45431
        • Indu and Raj Soin Medical Center
      • Centerville, Ohio, Forente stater, 45459
        • Miami Valley Hospital South
      • Centerville, Ohio, Forente stater, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Chardon, Ohio, Forente stater, 44024
        • Geauga Hospital
      • Cincinnati, Ohio, Forente stater, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cincinnati, Ohio, Forente stater, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Cleveland, Ohio, Forente stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Forente stater, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, Forente stater, 43219
        • The Mark H Zangmeister Center
      • Dayton, Ohio, Forente stater, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Forente stater, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Forente stater, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, Forente stater, 45415
        • Dayton Physician LLC - Englewood
      • Findlay, Ohio, Forente stater, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, Forente stater, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, Forente stater, 45840
        • Orion Cancer Care
      • Franklin, Ohio, Forente stater, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, Forente stater, 45005
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, Forente stater, 45331
        • Wayne Hospital
      • Greenville, Ohio, Forente stater, 45331
        • Dayton Physicians LLC-Wayne
      • Kettering, Ohio, Forente stater, 45429
        • Kettering Medical Center
      • Kettering, Ohio, Forente stater, 45409
        • Greater Dayton Cancer Center
      • Kettering, Ohio, Forente stater, 45420
        • First Dayton Cancer Care
      • Mansfield, Ohio, Forente stater, 44906
        • Cleveland Clinic Cancer Center Mansfield
      • Mayfield Heights, Ohio, Forente stater, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, Forente stater, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Middleburg Heights, Ohio, Forente stater, 44130
        • UH Seidman Cancer Center at Southwest General Hospital
      • Parma, Ohio, Forente stater, 44129
        • University Hospitals Parma Medical Center
      • Ravenna, Ohio, Forente stater, 44266
        • University Hospitals Portage Medical Center
      • Sandusky, Ohio, Forente stater, 44870
        • North Coast Cancer Care
      • Sandusky, Ohio, Forente stater, 44870
        • UH Seidman Cancer Center at Firelands Regional Medical Center
      • Springfield, Ohio, Forente stater, 45504
        • Springfield Regional Cancer Center
      • Springfield, Ohio, Forente stater, 45504
        • Springfield Regional Medical Center
      • Strongsville, Ohio, Forente stater, 44136
        • Cleveland Clinic Cancer Center Strongsville
      • Troy, Ohio, Forente stater, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, Forente stater, 45373
        • Dayton Physicians LLC - Troy
      • West Chester, Ohio, Forente stater, 45069
        • University of Cincinnati Cancer Center-West Chester
      • Westlake, Ohio, Forente stater, 44145
        • UHHS-Westlake Medical Center
      • Wooster, Ohio, Forente stater, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, Forente stater, 74133
        • Cancer Treatment Centers of America
    • Oregon
      • Gresham, Oregon, Forente stater, 97030
        • Legacy Mount Hood Medical Center
      • Portland, Oregon, Forente stater, 97210
        • Legacy Good Samaritan Hospital and Medical Center
    • Pennsylvania
      • Altoona, Pennsylvania, Forente stater, 16601
        • UPMC Altoona
      • Beaver, Pennsylvania, Forente stater, 15009
        • UPMC-Heritage Valley Health System Beaver
      • Bethlehem, Pennsylvania, Forente stater, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Chadds Ford, Pennsylvania, Forente stater, 19317
        • Christiana Care Health System-Concord Health Center
      • Dunmore, Pennsylvania, Forente stater, 18512
        • Northeast Radiation Oncology Center
      • Farrell, Pennsylvania, Forente stater, 16121
        • UPMC Cancer Center at UPMC Horizon
      • Greensburg, Pennsylvania, Forente stater, 15601
        • UPMC Cancer Centers - Arnold Palmer Pavilion
      • Harrisburg, Pennsylvania, Forente stater, 17109
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
      • Hershey, Pennsylvania, Forente stater, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Johnstown, Pennsylvania, Forente stater, 15901
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
      • McKeesport, Pennsylvania, Forente stater, 15132
        • UPMC Cancer Center at UPMC McKeesport
      • Monroeville, Pennsylvania, Forente stater, 15146
        • UPMC Cancer Center - Monroeville
      • Moon Township, Pennsylvania, Forente stater, 15108
        • UPMC Hillman Cancer Center in Coraopolis
      • Philadelphia, Pennsylvania, Forente stater, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19114
        • Jefferson Torresdale Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC-Magee Womens Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15232
        • UPMC-Shadyside Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15215
        • UPMC-Saint Margaret
      • Pittsburgh, Pennsylvania, Forente stater, 15237
        • UPMC-Passavant Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15243
        • UPMC-Saint Clair Hospital Cancer Center
      • Sayre, Pennsylvania, Forente stater, 18840
        • Guthrie Medical Group PC-Robert Packer Hospital
      • Seneca, Pennsylvania, Forente stater, 16346
        • UPMC Cancer Center at UPMC Northwest
      • Uniontown, Pennsylvania, Forente stater, 15401
        • UPMC Uniontown Hospital Radiation Oncology
      • Washington, Pennsylvania, Forente stater, 15301
        • UPMC Washington Hospital Radiation Oncology
      • West Reading, Pennsylvania, Forente stater, 19611
        • Reading Hospital
      • Willow Grove, Pennsylvania, Forente stater, 19090
        • Asplundh Cancer Pavilion
    • South Carolina
      • Boiling Springs, South Carolina, Forente stater, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Greenville, South Carolina, Forente stater, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Forente stater, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenwood, South Carolina, Forente stater, 29646
        • Self Regional Healthcare
      • Greer, South Carolina, Forente stater, 29650
        • Prisma Health Cancer Institute - Greer
      • Hilton Head Island, South Carolina, Forente stater, 29926
        • The Radiation Oncology Center-Hilton Head/Bluffton
      • Seneca, South Carolina, Forente stater, 29672
        • Prisma Health Cancer Institute - Seneca
    • South Dakota
      • Rapid City, South Dakota, Forente stater, 57701
        • Rapid City Regional Hospital
    • Tennessee
      • Germantown, Tennessee, Forente stater, 38138
        • The West Clinic - Wolf River
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Dallas, Texas, Forente stater, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • San Antonio, Texas, Forente stater, 78229
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forente stater, 78229
        • Audie L Murphy VA Hospital
    • Utah
      • American Fork, Utah, Forente stater, 84003
        • American Fork Hospital / Huntsman Intermountain Cancer Center
      • Cedar City, Utah, Forente stater, 84720
        • Sandra L Maxwell Cancer Center
      • Farmington, Utah, Forente stater, 84025
        • Farmington Health Center
      • Logan, Utah, Forente stater, 84321
        • Logan Regional Hospital
      • Murray, Utah, Forente stater, 84107
        • Intermountain Medical Center
      • Ogden, Utah, Forente stater, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, Forente stater, 84604
        • Utah Valley Regional Medical Center
      • Riverton, Utah, Forente stater, 84065
        • Riverton Hospital
      • Salt Lake City, Utah, Forente stater, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, Forente stater, 84106
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, Forente stater, 84143
        • LDS Hospital
      • St. George, Utah, Forente stater, 84770
        • Saint George Regional Medical Center
    • Vermont
      • Bennington, Vermont, Forente stater, 05201
        • Southwestern Vermont Medical Center
      • Berlin Corners, Vermont, Forente stater, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, Forente stater, 05401
        • University of Vermont Medical Center
      • Burlington, Vermont, Forente stater, 05405
        • University of Vermont and State Agricultural College
      • Saint Johnsbury, Vermont, Forente stater, 05819
        • Dartmouth Cancer Center - North
    • Virginia
      • Portsmouth, Virginia, Forente stater, 23708-2197
        • Naval Medical Center - Portsmouth
      • Richmond, Virginia, Forente stater, 23249
        • Hunter Holmes McGuire Veterans Administration Medical Center
    • Washington
      • Bellingham, Washington, Forente stater, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Vancouver, Washington, Forente stater, 98686
        • Legacy Salmon Creek Hospital
      • Walla Walla, Washington, Forente stater, 99362
        • Providence Saint Mary Regional Cancer Center
    • West Virginia
      • Morgantown, West Virginia, Forente stater, 26506
        • West Virginia University Healthcare
      • Parkersburg, West Virginia, Forente stater, 26101
        • Camden Clark Medical Center
    • Wisconsin
      • Eau Claire, Wisconsin, Forente stater, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Grafton, Wisconsin, Forente stater, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, Forente stater, 54311
        • Aurora BayCare Medical Center
      • Kenosha, Wisconsin, Forente stater, 53142
        • Aurora Cancer Care-Kenosha South
      • Marshfield, Wisconsin, Forente stater, 54449
        • Marshfield Medical Center-Marshfield
      • Menomonee Falls, Wisconsin, Forente stater, 53051
        • Froedtert Menomonee Falls Hospital
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, Forente stater, 53295
        • Zablocki Veterans Administration Medical Center
      • Minocqua, Wisconsin, Forente stater, 54548
        • Marshfield Medical Center - Minocqua
      • New Richmond, Wisconsin, Forente stater, 54017
        • Cancer Center of Western Wisconsin
      • Oshkosh, Wisconsin, Forente stater, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Rice Lake, Wisconsin, Forente stater, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, Forente stater, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Stevens Point, Wisconsin, Forente stater, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Summit, Wisconsin, Forente stater, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, Forente stater, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • West Allis, Wisconsin, Forente stater, 53227
        • Aurora West Allis Medical Center
      • West Bend, Wisconsin, Forente stater, 53095
        • Froedtert West Bend Hospital/Kraemer Cancer Center
      • Weston, Wisconsin, Forente stater, 54476
        • Marshfield Medical Center - Weston

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Patologisk (histologisk) bevist diagnose av prostataadenokarsinom; prostatektomi må ha blitt utført innen 10 år før trinn 1-registrering, og enhver type radikal prostatektomi er tillatt, inkludert retropubisk, perineal, laparoskopisk eller robotassistert

  • Pasienter etter prostatektomi med en påvisbar serum-PSA (≥ 0,1, men ≤ 1,0 ng/ml) ved studiestart (innen 90 dager etter registrering i trinn 1) og minst ett av følgende:

    • Gleason score 7-10 (International Society of Urological Pathology [ISUP] klasse 2 til 5)

    • ISUP karaktergruppe:

      • Karaktergruppe 1: Gleason-score ≤ 6,
      • Karaktergruppe 2: Gleason score 3 + 4 = 7,
      • Karaktergruppe 3: Gleason score 4 + 3 = 7,
      • Karaktergruppe 4: Gleason score 8,
      • Karaktergruppe 5: Gleason scorer 9 og 10
    • >= T3a sykdom
    • Vedvarende økning av PSA etter prostatektomi målt innen 90 dager etter operasjonen (PSA ble aldri upåviselig) på > 0,04 men < 0,2 ng/ml (PSA nadir)
  • pN0 eller pNx
  • Anamnese/fysisk undersøkelse innen 90 dager før trinn 1-registrering
  • Karnofsky ytelsesstatus på 70-100 innen 90 dager før trinn 1-registrering
  • Kirurgisk formalinfiksert parafininnstøpt (FFPE) prøve må være tilgjengelig for innsending til GenomeDx for genomisk analyse på Decipher GRID-plattformen; Merk: hvis dechiffreringsresultater allerede er oppnådd, i stedet for vev, må resultatene sendes til GenomeDx for validering

  • Tidligere behandling med androgen deprivasjon (luteiniserende hormonfrigjørende hormon [LHRH] agonist og/eller ikke-steroid antiandrogen) er tillatt hvis den seponeres minst 90 dager før trinn 1-registrering og gis i ≤ 90 dagers varighet

    • For eksempel: Pasienter på tidligere LHRH-analoger (post-prostatektomi), seponeringsdatoen bør beregnes basert på forventet varighet av injeksjonen med forsinket frigjøring, ikke bare injeksjonsdatoen for legemidlet; for eksempel, hvis en 22,5 mg dose med forsinket frigjøring av leuprolidacetat gis (3 måneders varighet), vil den forventede varigheten av en slik dose være 90 dager etter injeksjonsdatoen; for en 7,5 mg leuprolid (1 måneds varighet), vil seponeringsdatoen være 30 dager etter injeksjonsdatoen
    • Vennligst merk: finasterid eller dutasterid må stoppes før behandlingen starter, men tidligere bruk vil ikke påvirke kvalifikasjonen
  • Hemoglobin ≥ 9,0 g/dL, uavhengig av transfusjon og/eller vekstfaktorer innen 90 dager før trinn 1-registrering
  • Blodplateantall ≥ 100 000 x 10^9/uL uavhengig av transfusjon og/eller vekstfaktorer innen 90 dager før trinn 1-registrering
  • Serumalbumin ≥ 3,0 g/dL innen 90 dager før trinn 1-registrering
  • Glomerulær filtrasjonshastighet (GFR) ≥ 35 ml/min estimert av Cockcroft-Gault eller målt direkte med 24 timers urinkreatinin innen 90 dager før trinn 1-registrering
  • Totalt serumbilirubin ≤ 1,5 x øvre normalgrense (ULN) (Merk: hos personer med Gilberts syndrom, hvis total bilirubin er > 1,5 x ULN, mål direkte og indirekte bilirubin, og hvis direkte bilirubin er ≤ 1,5 x ULN, er pasienten kvalifisert) innen 90 dager før trinn 1-registrering
  • Aspartataminotransferase (AST) eller alaninaminotransferase (ALT) < 2,5 x ULN innen 90 dager før trinn 1-registrering
  • Testosteron > 50 ng/dL innen 90 dager før trinn 1-registrering
  • Samtidig medisinering som er kjent for å senke anfallsterskelen, ble avbrutt eller erstattet minst 4 uker (30 dager) før trinn 1-registrering.
  • Pasienten må godta å bruke kondom (selv menn med vasektomi) og en annen effektiv prevensjonsmetode hvis han har sex med en kvinne i fertil alder, eller samtykke i å bruke kondom hvis han har sex med en kvinne som er gravid mens på studiemedikament og i 3 måneder etter siste dose med studiemedisin
  • Pasienten må samtykke i å ikke donere sæd under studiebehandlingen og i 3 måneder etter å ha mottatt den siste dosen av studiemedikamentet
  • Pasienten eller en juridisk autorisert representant må gi studiespesifikt informert samtykke før studiestart

Ekskluderingskriterier:

  • Definitivt klinisk, radiologisk eller patologisk bevis på metastatisk sykdom (M1) eller lymfeknutepåvirkning (N1)
  • Tidligere invasiv malignitet (unntatt ikke-melanomatøs hudkreft, karsinom in situ i det mannlige brystet, penis, munnhulen eller stadium Ta i blæren, eller stadium I fullstendig resekert melanom) med mindre sykdomsfri i minst 2 år
  • Tidligere systemisk kjemoterapi for studien kreft; Vær oppmerksom på at tidligere kjemoterapi for en annen kreftform er tillatt
  • Tidligere strålebehandling til regionen av studien kreft som ville resultere i overlapping av stråleterapifelt

  • Historien om noen av følgende:

    • Anfall eller kjent tilstand som kan disponere for anfall (f.eks. tidligere hjerneslag innen 1 år før trinn 1-registrering)
    • Historie om dokumentert inflammatorisk tarmsykdom
    • Transmuralt hjerteinfarkt i løpet av de siste 4 månedene før trinn 1-registrering.
    • Ustabil angina og/eller kongestiv hjertesvikt som krever sykehusinnleggelse i løpet av de siste 6 månedene før trinn 1-registrering
    • Historie om enhver tilstand som etter etterforskerens mening ville utelukke deltakelse i denne studien

  • Gjeldende bevis på noen av følgende:

    • Kjent gastrointestinal lidelse som påvirker absorpsjon av orale medisiner
    • Aktiv ukontrollert infeksjon (f.eks. humant immunsviktvirus [HIV] eller viral hepatitt)
    • Ukontrollert hypertensjon
    • Enhver gjeldende tilstand som etter etterforskerens mening vil utelukke deltakelse i denne studien
  • Tidligere helkjertelablativ terapi (dvs. kryoablasjon eller høyintensitetsfokusert ultralyd [HIFU]) for prostatakreft er ikke tillatt
  • HIV-positiv med CD4-tall < 200 celler/mikroliter innen 30 dager før registrering
  • HIV-pasienter under behandling med høyaktiv antiretroviral terapi (HAART) innen 30 dager før registrering uavhengig av CD4-tall. (Merk: HIV-testing er ikke nødvendig for å være kvalifisert for denne protokollen da den er selvrapportert.)
  • For pasienter som ikke har gjennomgått tidligere Dechiffreringsanalyse, bør innsending av prøven til GenomeDx skje så snart som mulig etter studieregistrering (trinn 1), da disse resultatene kan ta opp 21 dager etter at prøven er mottatt på GenomeDx; Trinn 2-registrering må skje innen 6 uker (42 dager) etter Trinn 1-registrering; hvis dechiffreringsresultater allerede er oppnådd, i stedet for vev, må resultatene sendes til GenomeDx for validering
  • Pasienter må ikke planlegge å delta i andre kliniske studier mens de mottar behandling i denne studien eller blir fulgt etter protokollbehandling.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Arm 1 (strålebehandling, placebo)
Pasienter gjennomgår ekstern stråle strålebehandling på dag 1 i 7-8 uker. Fra og med dag med strålebehandling får pasienter placebo PO QD på dagene 1-30. Behandlingen gjentas hver 30. dag for opptil 6 sykluser i fravær av sykdomsprogresjon eller uakseptabel toksisitet.
Annen: Placebo administrasjon
Gitt PO
Stråling: Ekstern strålebehandling
Gjennomgå ekstern strålebehandling
Andre navn:
  • EBRT
  • Definitiv strålebehandling
  • Ekstern strålestråling
  • Ekstern strålebehandling
  • Ekstern Beam RT
  • ekstern stråling
  • ekstern strålestråling
  • Stråling, ekstern stråle
  • Teleradioterapi
  • Teleterapi
  • Teleterapi stråling
  • Ekstern strålebehandling (konvensjonell)
Eksperimentell: Arm 2 (strålebehandling, apalutamid)
Pasienter gjennomgår ekstern stråle strålebehandling på dag 1 i 7-8 uker. Fra og med dag med strålebehandling får pasienter apalutamid PO QD på dagene 1-30. Behandlingen gjentas hver 30. dag for opptil 6 sykluser i fravær av sykdomsprogresjon eller uakseptabel toksisitet.
Legemiddel: Apalutamid
Gitt PO
Andre navn:
  • ARN-509
  • JNJ-56021927
  • ARN 509
  • ARN509
  • Erleada
  • JNJ 56021927
Stråling: Ekstern strålebehandling
Gjennomgå ekstern strålebehandling
Andre navn:
  • EBRT
  • Definitiv strålebehandling
  • Ekstern strålestråling
  • Ekstern strålebehandling
  • Ekstern Beam RT
  • ekstern stråling
  • ekstern strålestråling
  • Stråling, ekstern stråle
  • Teleradioterapi
  • Teleterapi
  • Teleterapi stråling
  • Ekstern strålebehandling (konvensjonell)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)
Tidsramme: 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.

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.
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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Alive (Overall Survival)
Tidsramme: 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.
Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
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.
Percentage of Participants Who Have Died Due to Prostate Cancer (Cancer-specific Mortality (CSM))
Tidsramme: 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.
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.
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.
Percentage of Participants Alive Without Distant Metastases (Metastasis-free Survival (MFS))
Tidsramme: 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.
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.
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.
Percentage of Participants With Distant Metastasis
Tidsramme: 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.
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.
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.
Percentage of Participants Wtih Local-regional Progression
Tidsramme: 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.
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.
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.
PSA Nadir During First Year of Treatment and Prior to Initiation of Any Hormonal Salvage Therapy
Tidsramme: First year of treatment
Will be compared between the two groups using a two-sample t-test.
First year of treatment
Percentage of Participants That Started Salvage Hormonal Therapy
Tidsramme: 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.
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.
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.
Proportion of Participants With Undetectable PSA (< 0.1) and Non-castrate Testosterone (≥ 50 ng/dl) at One and Three Years
Tidsramme: One and three years
One and three years
Number of Participants With Grade 3+ Adverse Events Occurring Within 30 Days After the Completion of RT
Tidsramme: Up to 30 days after radiation therapy, which lasts approximately 7-8 weeks from treatment start.
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.
Up to 30 days after radiation therapy, which lasts approximately 7-8 weeks from treatment start.
Number of Participants With Grade 3+ Adverse Events Occurring More Than 30 Days After the Completion of Radiation Therapy
Tidsramme: 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.
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.
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.
Testosterone Levels
Tidsramme: 3, 6, 9, and 12 months
Testosterone levels will be reported at this time points.
3, 6, 9, and 12 months
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
Tidsramme: Up to 5 years
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.
Up to 5 years
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
Tidsramme: From the end of radiation therapy (approximately 7-8 weeks from treatment start) to two years.
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.
From the end of radiation therapy (approximately 7-8 weeks from treatment start) to two years.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

NRG Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Felix Y Feng, NRG Oncology

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. juni 2018

Primær fullføring (Faktiske)

10. mars 2025

Studiet fullført (Antatt)

27. oktober 2026

Datoer for studieregistrering

Først innsendt

8. desember 2017

Først innsendt som oppfylte QC-kriteriene

8. desember 2017

Først lagt ut (Faktiske)

13. desember 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. august 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NRG-GU006 (Annen identifikator: CTEP)
  • U10CA180868 (U.S. NIH-stipend/kontrakt)
  • NCI-2017-01268 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere