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再発性前立腺がんに対するアパルタミドと放射線のバイオマーカー試験

2026年9月9日 更新者：NRG Oncology

再発前立腺癌におけるアパルタミドによる強化抗アンドロゲン療法の有無にかかわらず、サルベージ放射線療法の第II相、二重盲検、プラセボ対照無作為化試験

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

PRIMARY OBJECTIVE:

I. 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:

I. 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.

X. 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:

I. 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.

研究の種類

介入

入学 (実際)

298

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

男

説明

Inclusion Criteria:

  • 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,
      • 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

Exclusion Criteria:

  • 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:

    • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Arm 1 (radiation therapy, placebo)

Patients 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.
他の：Placebo Administration

Given PO

放射線：External Beam Radiation Therapy

Undergo external beam radiation therapy

他の名前：
  • EBRT
  • 根治的放射線療法
  • 外部ビーム放射
  • 外照射放射線治療
  • 外部ビーム RT
  • 外部放射線
  • 外照射療法
  • 放射線、外部ビーム
  • 遠隔放射線療法
  • 遠隔治療
  • 遠隔治療放射線
  • 外照射療法（従来）
実験的：Arm 2 (radiation therapy, apalutamide)

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.
放射線：External Beam Radiation Therapy

Undergo external beam radiation therapy

他の名前：
  • EBRT
  • 根治的放射線療法
  • 外部ビーム放射
  • 外照射放射線治療
  • 外部ビーム RT
  • 外部放射線
  • 外照射療法
  • 放射線、外部ビーム
  • 遠隔放射線療法
  • 遠隔治療
  • 遠隔治療放射線
  • 外照射療法（従来）
薬：Apalutamide

Given PO

他の名前：
  • ARN-509
  • JNJ-56021927
  • ARN 509
  • ARN509
  • エルレアダ
  • JNJ 56021927

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of Participants With Undetectable PSA (< 0.1) and Non-castrate Testosterone (≥ 50 ng/dl) at One and Three Years
時間枠：One and three years
One and three years
Percentage of Participants Alive (Overall Survival)
時間枠：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))
時間枠：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))
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
Number of Participants With Grade 3+ Adverse Events Occurring Within 30 Days After the Completion of RT
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

NRG Oncology

協力者

National Cancer Institute (NCI)

捜査官

  • 主任研究者：Felix Y Feng、NRG Oncology

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年6月20日

一次修了 (実際)

2025年3月10日

研究の完了 (推定)

2030年3月10日

試験登録日

最初に提出

2017年12月8日

QC基準を満たした最初の提出物

2017年12月8日

最初の投稿 (実際)

2017年12月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月1日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • NRG-GU006
  • U10CA180868 (米国 NIH グラント/契約)
  • NRG-GU006 (その他の識別子：CTEP)
  • NCI-2017-01268 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
  • NRG-GU006 (その他の識別子：NRG Oncology)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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