BIOMARKÖR FÖRSÖKNING av APALUTAMID och STRÅLNING för återkommande prostatacancer
En fas II, dubbelblind, placebokontrollerad randomiserad studie av räddningsstrålbehandling med eller utan förbättrad antiandrogenterapi med apalutamid vid återkommande prostatacancer
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Arizona
-
Gilbert, Arizona, Förenta staterna, 85297
- Arizona Center for Cancer Care - Gilbert
-
Peoria, Arizona, Förenta staterna, 85381
- Arizona Center for Cancer Care-Peoria
-
Scottsdale, Arizona, Förenta staterna, 85258
- Arizona Center for Cancer Care - Scottsdale
-
Surprise, Arizona, Förenta staterna, 85374
- Arizona Center for Cancer Care-Surprise
-
-
Arkansas
-
Little Rock, Arkansas, Förenta staterna, 72205
- University of Arkansas for Medical Sciences
-
-
California
-
Berkeley, California, Förenta staterna, 94704
- Alta Bates Summit Medical Center-Herrick Campus
-
Greenbrae, California, Förenta staterna, 94904
- Marin General Hospital
-
Los Angeles, California, Förenta staterna, 90033
- USC / Norris Comprehensive Cancer Center
-
Los Angeles, California, Förenta staterna, 90048
- Cedars Sinai Medical Center
-
Los Angeles, California, Förenta staterna, 90033
- Los Angeles General Medical Center
-
Roseville, California, Förenta staterna, 95661
- Sutter Cancer Centers Radiation Oncology Services-Roseville
-
Sacramento, California, Förenta staterna, 95816
- Sutter Medical Center Sacramento
-
Sacramento, California, Förenta staterna, 95817
- University of California Davis Comprehensive Cancer Center
-
Truckee, California, Förenta staterna, 96161
- Gene Upshaw Memorial Tahoe Forest Cancer Center
-
Vallejo, California, Förenta staterna, 94589
- Sutter Solano Medical Center/Cancer Center
-
-
Colorado
-
Aurora, Colorado, Förenta staterna, 80045
- UCHealth University of Colorado Hospital
-
Colorado Springs, Colorado, Förenta staterna, 80907
- Penrose-Saint Francis Healthcare
-
Colorado Springs, Colorado, Förenta staterna, 80909
- UCHealth Memorial Hospital Central
-
Colorado Springs, Colorado, Förenta staterna, 80920
- Memorial Hospital North
-
Fort Collins, Colorado, Förenta staterna, 80524
- Poudre Valley Hospital
-
Fort Collins, Colorado, Förenta staterna, 80528
- Cancer Care and Hematology-Fort Collins
-
Glenwood Springs, Colorado, Förenta staterna, 81601
- Valley View Hospital Cancer Center
-
Greeley, Colorado, Förenta staterna, 80631
- UCHealth Greeley Hospital
-
Loveland, Colorado, Förenta staterna, 80538
- Medical Center of the Rockies
-
-
Connecticut
-
Stamford, Connecticut, Förenta staterna, 06904
- Stamford Hospital/Bennett Cancer Center
-
-
Delaware
-
Newark, Delaware, Förenta staterna, 19713
- Helen F Graham Cancer Center
-
Newark, Delaware, Förenta staterna, 19718
- Christiana Care Health System-Christiana Hospital
-
Rehoboth Beach, Delaware, Förenta staterna, 19971
- Beebe Health Campus
-
-
District of Columbia
-
Washington D.C., District of Columbia, Förenta staterna, 20037
- George Washington University Medical Center
-
-
Florida
-
Altamonte Springs, Florida, Förenta staterna, 32701
- AdventHealth Altamonte
-
Fort Myers, Florida, Förenta staterna, 33905
- Regional Cancer Center-Lee Memorial Health System
-
Kissimmee, Florida, Förenta staterna, 34744
- AdventHealth Kissimmee
-
Orlando, Florida, Förenta staterna, 32803
- AdventHealth Orlando
-
Orlando, Florida, Förenta staterna, 32822
- AdventHealth East Orlando
-
Weston, Florida, Förenta staterna, 33331
- Cleveland Clinic-Weston
-
Winter Park, Florida, Förenta staterna, 32792
- AdventHealth Winter Park
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30308
- Emory University Hospital Midtown
-
Atlanta, Georgia, Förenta staterna, 30322
- Emory University Hospital/Winship Cancer Institute
-
Atlanta, Georgia, Förenta staterna, 30342
- Emory Saint Joseph's Hospital
-
Atlanta, Georgia, Förenta staterna, 30303
- Grady Health System
-
Atlanta, Georgia, Förenta staterna, 30342
- Northside Hospital
-
Augusta, Georgia, Förenta staterna, 30912
- Augusta University Medical Center
-
Savannah, Georgia, Förenta staterna, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
-
-
Idaho
-
Boise, Idaho, Förenta staterna, 83712
- Saint Luke's Cancer Institute - Boise
-
Fruitland, Idaho, Förenta staterna, 83619
- Saint Luke's Cancer Institute - Fruitland
-
Meridian, Idaho, Förenta staterna, 83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa, Idaho, Förenta staterna, 83687
- Saint Luke's Cancer Institute - Nampa
-
Twin Falls, Idaho, Förenta staterna, 83301
- Saint Luke's Cancer Institute - Twin Falls
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60612
- University of Illinois
-
Chicago, Illinois, Förenta staterna, 60612
- Rush MD Anderson Cancer Center
-
Decatur, Illinois, Förenta staterna, 62526
- Decatur Memorial Hospital
-
Effingham, Illinois, Förenta staterna, 62401
- Crossroads Cancer Center
-
Hines, Illinois, Förenta staterna, 60141
- Edward Hines Jr VA Hospital
-
Maywood, Illinois, Förenta staterna, 60153
- Loyola University Medical Center
-
Peoria, Illinois, Förenta staterna, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, Förenta staterna, 61615
- Illinois CancerCare-Peoria
-
Peoria, Illinois, Förenta staterna, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
-
Springfield, Illinois, Förenta staterna, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, Förenta staterna, 62702
- Springfield Clinic
-
Springfield, Illinois, Förenta staterna, 62781
- Springfield Memorial Hospital
-
Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center
-
-
Indiana
-
Fort Wayne, Indiana, Förenta staterna, 46805
- Parkview Hospital Randallia
-
Fort Wayne, Indiana, Förenta staterna, 46845
- Parkview Regional Medical Center
-
Goshen, Indiana, Förenta staterna, 46526
- Goshen Center for Cancer Care
-
Richmond, Indiana, Förenta staterna, 47374
- Reid Health
-
-
Iowa
-
Clive, Iowa, Förenta staterna, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, Förenta staterna, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Creston, Iowa, Förenta staterna, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, Förenta staterna, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Förenta staterna, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
West Des Moines, Iowa, Förenta staterna, 50266
- Mercy Medical Center-West Lakes
-
-
Kansas
-
Kansas City, Kansas, Förenta staterna, 66160
- University of Kansas Cancer Center
-
Olathe, Kansas, Förenta staterna, 66061
- The University of Kansas Cancer Center - Olathe
-
Overland Park, Kansas, Förenta staterna, 66210
- University of Kansas Cancer Center-Overland Park
-
Salina, Kansas, Förenta staterna, 67401
- Salina Regional Health Center
-
Westwood, Kansas, Förenta staterna, 66205
- University of Kansas Hospital-Westwood Cancer Center
-
-
Kentucky
-
Lexington, Kentucky, Förenta staterna, 40536
- University of Kentucky/Markey Cancer Center
-
-
Louisiana
-
Baton Rouge, Louisiana, Förenta staterna, 70809
- Mary Bird Perkins Cancer Center
-
Metairie, Louisiana, Förenta staterna, 70006
- East Jefferson General Hospital
-
Metairie, Louisiana, Förenta staterna, 70006
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
-
-
Maine
-
Bath, Maine, Förenta staterna, 04530
- MaineHealth Coastal Cancer Treatment Center
-
Belfast, Maine, Förenta staterna, 04915
- MaineHealth Waldo Hospital
-
Biddeford, Maine, Förenta staterna, 04005
- MaineHealth Maine Medical Center - Biddeford
-
Brewer, Maine, Förenta staterna, 04412
- Lafayette Family Cancer Center-EMMC
-
Norway, Maine, Förenta staterna, 04268
- MaineHealth Stephens Hospital
-
Portland, Maine, Förenta staterna, 04102
- MaineHealth Maine Medical Center - Portland
-
Rockport, Maine, Förenta staterna, 04856
- Penobscot Bay Medical Center
-
Sanford, Maine, Förenta staterna, 04073
- MaineHealth Cancer Care Center of York County
-
Sanford, Maine, Förenta staterna, 04073
- MaineHealth Cancer Care and IV Therapy - Sanford
-
Scarborough, Maine, Förenta staterna, 04074
- MaineHealth Maine Medical Center- Scarborough
-
South Portland, Maine, Förenta staterna, 04106
- MaineHealth Cancer Care and IV Therapy - South Portland
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland/Greenebaum Cancer Center
-
Baltimore, Maryland, Förenta staterna, 21229
- Saint Agnes Hospital
-
Columbia, Maryland, Förenta staterna, 21044
- Central Maryland Radiation Oncology in Howard County
-
Glen Burnie, Maryland, Förenta staterna, 21061
- UM Baltimore Washington Medical Center/Tate Cancer Center
-
-
Massachusetts
-
Burlington, Massachusetts, Förenta staterna, 01805
- Lahey Hospital and Medical Center
-
Lowell, Massachusetts, Förenta staterna, 01854
- Lowell General Hospital
-
-
Michigan
-
Ann Arbor, Michigan, Förenta staterna, 48109
- University of Michigan Rogel Cancer Center
-
Ann Arbor, Michigan, Förenta staterna, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Battle Creek, Michigan, Förenta staterna, 49017
- Bronson Battle Creek
-
Brighton, Michigan, Förenta staterna, 48114
- Trinity Health Medical Center - Brighton
-
Canton, Michigan, Förenta staterna, 48188
- Trinity Health Medical Center - Canton
-
Chelsea, Michigan, Förenta staterna, 48118
- Chelsea Hospital
-
Clarkston, Michigan, Förenta staterna, 48346
- Michigan Healthcare Professionals Clarkston
-
Clinton Township, Michigan, Förenta staterna, 48038
- Henry Ford Macomb Hospital-Clinton Township
-
Dearborn, Michigan, Förenta staterna, 48124
- Corewell Health Dearborn Hospital
-
Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Hospital
-
East Lansing, Michigan, Förenta staterna, 48823
- Michigan State University
-
Farmington Hills, Michigan, Förenta staterna, 48334
- Michigan Healthcare Professionals Farmington
-
Grand Rapids, Michigan, Förenta staterna, 49503
- Trinity Health Grand Rapids Hospital
-
Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Kalamazoo, Michigan, Förenta staterna, 49007
- West Michigan Cancer Center
-
Lansing, Michigan, Förenta staterna, 48912
- University of Michigan Health - Sparrow Lansing
-
Niles, Michigan, Förenta staterna, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Reed City, Michigan, Förenta staterna, 49677
- Corewell Health Reed City Hospital
-
Royal Oak, Michigan, Förenta staterna, 48073
- Corewell Health William Beaumont University Hospital
-
Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Traverse City, Michigan, Förenta staterna, 49684
- Munson Medical Center
-
Troy, Michigan, Förenta staterna, 48098
- Michigan Healthcare Professionals Troy
-
Troy, Michigan, Förenta staterna, 48085
- Corewell Health Beaumont Troy Hospital
-
West Bloomfield, Michigan, Förenta staterna, 48322
- Henry Ford West Bloomfield Hospital
-
Wyoming, Michigan, Förenta staterna, 49519
- University of Michigan Health - West
-
-
Minnesota
-
Albert Lea, Minnesota, Förenta staterna, 56007
- Mayo Clinic Health System in Albert Lea
-
Burnsville, Minnesota, Förenta staterna, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy Hospital
-
Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Förenta staterna, 55432
- Unity Hospital
-
Mankato, Minnesota, Förenta staterna, 56001
- Mayo Clinic Health Systems-Mankato
-
Maple Grove, Minnesota, Förenta staterna, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, Förenta staterna, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Förenta staterna, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Förenta staterna, 55454
- Health Partners Inc
-
Minneapolis, Minnesota, Förenta staterna, 55417
- Minneapolis VA Medical Center
-
Monticello, Minnesota, Förenta staterna, 55362
- Monticello Cancer Center
-
Robbinsdale, Minnesota, Förenta staterna, 55422
- North Memorial Medical Health Center
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic in Rochester
-
Saint Cloud, Minnesota, Förenta staterna, 56303
- Coborn Cancer Center at Saint Cloud Hospital
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
-
Shakopee, Minnesota, Förenta staterna, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Förenta staterna, 55082
- Lakeview Hospital
-
Waconia, Minnesota, Förenta staterna, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Förenta staterna, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Wyoming, Minnesota, Förenta staterna, 55092
- Fairview Lakes Medical Center
-
-
Mississippi
-
Jackson, Mississippi, Förenta staterna, 39216
- University of Mississippi Medical Center
-
-
Missouri
-
Cape Girardeau, Missouri, Förenta staterna, 63703
- Mercy Cancer Center - Cape Girardeau
-
City of Saint Peters, Missouri, Förenta staterna, 63376
- Siteman Cancer Center at Saint Peters Hospital
-
Creve Coeur, Missouri, Förenta staterna, 63141
- Siteman Cancer Center at West County Hospital
-
Jefferson City, Missouri, Förenta staterna, 65109
- MU Health Care Goldschmidt Cancer Center
-
Kansas City, Missouri, Förenta staterna, 64128
- Kansas City Veterans Affairs Medical Center
-
Kansas City, Missouri, Förenta staterna, 64154
- University of Kansas Cancer Center - North
-
Lee's Summit, Missouri, Förenta staterna, 64064
- University of Kansas Cancer Center - Lee's Summit
-
Rolla, Missouri, Förenta staterna, 65401
- Phelps Health Delbert Day Cancer Institute
-
St Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Förenta staterna, 63129
- Siteman Cancer Center-South County
-
St Louis, Missouri, Förenta staterna, 63141
- Mercy Hospital Saint Louis
-
-
Montana
-
Billings, Montana, Förenta staterna, 59101
- Billings Clinic Cancer Center
-
Bozeman, Montana, Förenta staterna, 59715
- Bozeman Health Deaconess Hospital
-
Great Falls, Montana, Förenta staterna, 59405
- Benefis Sletten Cancer Institute
-
-
Nebraska
-
Omaha, Nebraska, Förenta staterna, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, Förenta staterna, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, Förenta staterna, 68124
- Alegent Health Bergan Mercy Medical Center
-
-
Nevada
-
Henderson, Nevada, Förenta staterna, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Förenta staterna, 89052
- OptumCare Cancer Care at Seven Hills
-
Henderson, Nevada, Förenta staterna, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Förenta staterna, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Förenta staterna, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, Förenta staterna, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Förenta staterna, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, Förenta staterna, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Förenta staterna, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Förenta staterna, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Förenta staterna, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Förenta staterna, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, Förenta staterna, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Förenta staterna, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Förenta staterna, 89148
- OptumCare Cancer Care at Fort Apache
-
Las Vegas, Nevada, Förenta staterna, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Förenta staterna, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Förenta staterna, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Förenta staterna, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Förenta staterna, 89121
- Cancer Therapy and Integrative Medicine
-
Las Vegas, Nevada, Förenta staterna, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Förenta staterna, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Förenta staterna, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Förenta staterna, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, Förenta staterna, 89102
- Desert West Surgery
-
Las Vegas, Nevada, Förenta staterna, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, Förenta staterna, 89169
- University Cancer Center
-
Las Vegas, Nevada, Förenta staterna, 89128
- Oncology Las Vegas - Tenaya
-
Pahrump, Nevada, Förenta staterna, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, Förenta staterna, 89509
- Radiation Oncology Associates
-
-
New Hampshire
-
Concord, New Hampshire, Förenta staterna, 03301
- New Hampshire Oncology Hematology PA-Concord
-
Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
Manchester, New Hampshire, Förenta staterna, 03103
- Solinsky Center for Cancer Care
-
-
New Jersey
-
Mount Holly, New Jersey, Förenta staterna, 08060
- Virtua Memorial
-
New Brunswick, New Jersey, Förenta staterna, 08903
- Rutgers Cancer Institute of New Jersey
-
Sewell, New Jersey, Förenta staterna, 08080
- Sidney Kimmel Cancer Center Washington Township
-
Somerville, New Jersey, Förenta staterna, 08876
- Robert Wood Johnson University Hospital Somerset
-
-
New Mexico
-
Albuquerque, New Mexico, Förenta staterna, 87109
- New Mexico Oncology Hematology Consultants
-
Albuquerque, New Mexico, Förenta staterna, 87106
- University of New Mexico Cancer Center
-
-
New York
-
Brooklyn, New York, Förenta staterna, 11215
- New York-Presbyterian/Brooklyn Methodist Hospital
-
Canandaigua, New York, Förenta staterna, 14424
- Sands Cancer Center
-
Cooperstown, New York, Förenta staterna, 13326
- Mary Imogene Bassett Hospital
-
New York, New York, Förenta staterna, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, Förenta staterna, 14642
- University of Rochester
-
Rochester, New York, Förenta staterna, 14620
- Highland Hospital
-
Rochester, New York, Förenta staterna, 14606
- Wilmot Cancer Institute Radiation Oncology at Greece
-
Stony Brook, New York, Förenta staterna, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, Förenta staterna, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, Förenta staterna, 10468
- James J Peters VA Medical Center
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Supply, North Carolina, Förenta staterna, 28462
- Novant Cancer Institute Radiation Oncology - Supply
-
Wilmington, North Carolina, Förenta staterna, 28401
- Novant Health New Hanover Regional Medical Center
-
Wilmington, North Carolina, Förenta staterna, 28401
- Novant Health Cancer Institute Radiation Oncology - Wilmington
-
-
Ohio
-
Akron, Ohio, Förenta staterna, 44307
- Cleveland Clinic Akron General
-
Akron, Ohio, Förenta staterna, 44304
- Summa Health System - Akron Campus
-
Beachwood, Ohio, Förenta staterna, 44122
- UHHS-Chagrin Highlands Medical Center
-
Beavercreek, Ohio, Förenta staterna, 45431
- Indu and Raj Soin Medical Center
-
Centerville, Ohio, Förenta staterna, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, Förenta staterna, 45459
- Dayton Physicians LLC-Miami Valley South
-
Chardon, Ohio, Förenta staterna, 44024
- Geauga Hospital
-
Cincinnati, Ohio, Förenta staterna, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, Förenta staterna, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cleveland, Ohio, Förenta staterna, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Förenta staterna, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, Förenta staterna, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, Förenta staterna, 43219
- The Mark H Zangmeister Center
-
Dayton, Ohio, Förenta staterna, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, Förenta staterna, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Förenta staterna, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, Förenta staterna, 45415
- Dayton Physician LLC - Englewood
-
Findlay, Ohio, Förenta staterna, 45840
- Blanchard Valley Hospital
-
Findlay, Ohio, Förenta staterna, 45840
- Armes Family Cancer Center
-
Findlay, Ohio, Förenta staterna, 45840
- Orion Cancer Care
-
Franklin, Ohio, Förenta staterna, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin, Ohio, Förenta staterna, 45005
- Dayton Physicians LLC-Atrium
-
Greenville, Ohio, Förenta staterna, 45331
- Wayne Hospital
-
Greenville, Ohio, Förenta staterna, 45331
- Dayton Physicians LLC-Wayne
-
Kettering, Ohio, Förenta staterna, 45429
- Kettering Medical Center
-
Kettering, Ohio, Förenta staterna, 45409
- Greater Dayton Cancer Center
-
Kettering, Ohio, Förenta staterna, 45420
- First Dayton Cancer Care
-
Mansfield, Ohio, Förenta staterna, 44906
- Cleveland Clinic Cancer Center Mansfield
-
Mayfield Heights, Ohio, Förenta staterna, 44124
- Hillcrest Hospital Cancer Center
-
Mentor, Ohio, Förenta staterna, 44060
- UH Seidman Cancer Center at Lake Health Mentor Campus
-
Middleburg Heights, Ohio, Förenta staterna, 44130
- UH Seidman Cancer Center at Southwest General Hospital
-
Parma, Ohio, Förenta staterna, 44129
- University Hospitals Parma Medical Center
-
Ravenna, Ohio, Förenta staterna, 44266
- University Hospitals Portage Medical Center
-
Sandusky, Ohio, Förenta staterna, 44870
- North Coast Cancer Care
-
Sandusky, Ohio, Förenta staterna, 44870
- UH Seidman Cancer Center at Firelands Regional Medical Center
-
Springfield, Ohio, Förenta staterna, 45504
- Springfield Regional Cancer Center
-
Springfield, Ohio, Förenta staterna, 45504
- Springfield Regional Medical Center
-
Strongsville, Ohio, Förenta staterna, 44136
- Cleveland Clinic Cancer Center Strongsville
-
Troy, Ohio, Förenta staterna, 45373
- Upper Valley Medical Center
-
Troy, Ohio, Förenta staterna, 45373
- Dayton Physicians LLC - Troy
-
West Chester, Ohio, Förenta staterna, 45069
- University of Cincinnati Cancer Center-West Chester
-
Westlake, Ohio, Förenta staterna, 44145
- UHHS-Westlake Medical Center
-
Wooster, Ohio, Förenta staterna, 44691
- Cleveland Clinic Wooster Family Health and Surgery Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Förenta staterna, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, Förenta staterna, 74133
- Cancer Treatment Centers of America
-
-
Oregon
-
Gresham, Oregon, Förenta staterna, 97030
- Legacy Mount Hood Medical Center
-
Portland, Oregon, Förenta staterna, 97210
- Legacy Good Samaritan Hospital and Medical Center
-
-
Pennsylvania
-
Altoona, Pennsylvania, Förenta staterna, 16601
- UPMC Altoona
-
Beaver, Pennsylvania, Förenta staterna, 15009
- UPMC-Heritage Valley Health System Beaver
-
Bethlehem, Pennsylvania, Förenta staterna, 18015
- Saint Luke's University Hospital-Bethlehem Campus
-
Chadds Ford, Pennsylvania, Förenta staterna, 19317
- Christiana Care Health System-Concord Health Center
-
Dunmore, Pennsylvania, Förenta staterna, 18512
- Northeast Radiation Oncology Center
-
Farrell, Pennsylvania, Förenta staterna, 16121
- UPMC Cancer Center at UPMC Horizon
-
Greensburg, Pennsylvania, Förenta staterna, 15601
- UPMC Cancer Centers - Arnold Palmer Pavilion
-
Harrisburg, Pennsylvania, Förenta staterna, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
-
Hershey, Pennsylvania, Förenta staterna, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Johnstown, Pennsylvania, Förenta staterna, 15901
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
-
McKeesport, Pennsylvania, Förenta staterna, 15132
- UPMC Cancer Center at UPMC McKeesport
-
Monroeville, Pennsylvania, Förenta staterna, 15146
- UPMC Cancer Center - Monroeville
-
Moon Township, Pennsylvania, Förenta staterna, 15108
- UPMC Hillman Cancer Center in Coraopolis
-
Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Förenta staterna, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Förenta staterna, 19114
- Jefferson Torresdale Hospital
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- UPMC-Magee Womens Hospital
-
Pittsburgh, Pennsylvania, Förenta staterna, 15232
- UPMC-Shadyside Hospital
-
Pittsburgh, Pennsylvania, Förenta staterna, 15215
- UPMC-Saint Margaret
-
Pittsburgh, Pennsylvania, Förenta staterna, 15237
- UPMC-Passavant Hospital
-
Pittsburgh, Pennsylvania, Förenta staterna, 15243
- UPMC-Saint Clair Hospital Cancer Center
-
Sayre, Pennsylvania, Förenta staterna, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
Seneca, Pennsylvania, Förenta staterna, 16346
- UPMC Cancer Center at UPMC Northwest
-
Uniontown, Pennsylvania, Förenta staterna, 15401
- UPMC Uniontown Hospital Radiation Oncology
-
Washington, Pennsylvania, Förenta staterna, 15301
- UPMC Washington Hospital Radiation Oncology
-
West Reading, Pennsylvania, Förenta staterna, 19611
- Reading Hospital
-
Willow Grove, Pennsylvania, Förenta staterna, 19090
- Asplundh Cancer Pavilion
-
-
South Carolina
-
Boiling Springs, South Carolina, Förenta staterna, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Förenta staterna, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenwood, South Carolina, Förenta staterna, 29646
- Self Regional Healthcare
-
Greer, South Carolina, Förenta staterna, 29650
- Prisma Health Cancer Institute - Greer
-
Hilton Head Island, South Carolina, Förenta staterna, 29926
- The Radiation Oncology Center-Hilton Head/Bluffton
-
Seneca, South Carolina, Förenta staterna, 29672
- Prisma Health Cancer Institute - Seneca
-
-
South Dakota
-
Rapid City, South Dakota, Förenta staterna, 57701
- Rapid City Regional Hospital
-
-
Tennessee
-
Germantown, Tennessee, Förenta staterna, 38138
- The West Clinic - Wolf River
-
Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
San Antonio, Texas, Förenta staterna, 78229
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Förenta staterna, 78229
- Audie L Murphy VA Hospital
-
-
Utah
-
American Fork, Utah, Förenta staterna, 84003
- American Fork Hospital / Huntsman Intermountain Cancer Center
-
Cedar City, Utah, Förenta staterna, 84720
- Sandra L Maxwell Cancer Center
-
Farmington, Utah, Förenta staterna, 84025
- Farmington Health Center
-
Logan, Utah, Förenta staterna, 84321
- Logan Regional Hospital
-
Murray, Utah, Förenta staterna, 84107
- Intermountain Medical Center
-
Ogden, Utah, Förenta staterna, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, Förenta staterna, 84604
- Utah Valley Regional Medical Center
-
Riverton, Utah, Förenta staterna, 84065
- Riverton Hospital
-
Salt Lake City, Utah, Förenta staterna, 84112
- Huntsman Cancer Institute/University of Utah
-
Salt Lake City, Utah, Förenta staterna, 84106
- Utah Cancer Specialists-Salt Lake City
-
Salt Lake City, Utah, Förenta staterna, 84143
- LDS Hospital
-
St. George, Utah, Förenta staterna, 84770
- Saint George Regional Medical Center
-
-
Vermont
-
Bennington, Vermont, Förenta staterna, 05201
- Southwestern Vermont Medical Center
-
Berlin Corners, Vermont, Förenta staterna, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
-
Burlington, Vermont, Förenta staterna, 05401
- University of Vermont Medical Center
-
Burlington, Vermont, Förenta staterna, 05405
- University of Vermont and State Agricultural College
-
Saint Johnsbury, Vermont, Förenta staterna, 05819
- Dartmouth Cancer Center - North
-
-
Virginia
-
Portsmouth, Virginia, Förenta staterna, 23708-2197
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, Förenta staterna, 23249
- Hunter Holmes McGuire Veterans Administration Medical Center
-
-
Washington
-
Bellingham, Washington, Förenta staterna, 98225
- PeaceHealth Saint Joseph Medical Center
-
Vancouver, Washington, Förenta staterna, 98686
- Legacy Salmon Creek Hospital
-
Walla Walla, Washington, Förenta staterna, 99362
- Providence Saint Mary Regional Cancer Center
-
-
West Virginia
-
Morgantown, West Virginia, Förenta staterna, 26506
- West Virginia University Healthcare
-
Parkersburg, West Virginia, Förenta staterna, 26101
- Camden Clark Medical Center
-
-
Wisconsin
-
Eau Claire, Wisconsin, Förenta staterna, 54701
- Marshfield Medical Center-EC Cancer Center
-
Grafton, Wisconsin, Förenta staterna, 53024
- Aurora Cancer Care-Grafton
-
Green Bay, Wisconsin, Förenta staterna, 54311
- Aurora BayCare Medical Center
-
Kenosha, Wisconsin, Förenta staterna, 53142
- Aurora Cancer Care-Kenosha South
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Medical Center-Marshfield
-
Menomonee Falls, Wisconsin, Förenta staterna, 53051
- Froedtert Menomonee Falls Hospital
-
Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, Förenta staterna, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, Förenta staterna, 53295
- Zablocki Veterans Administration Medical Center
-
Minocqua, Wisconsin, Förenta staterna, 54548
- Marshfield Medical Center - Minocqua
-
New Richmond, Wisconsin, Förenta staterna, 54017
- Cancer Center of Western Wisconsin
-
Oshkosh, Wisconsin, Förenta staterna, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Rice Lake, Wisconsin, Förenta staterna, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Förenta staterna, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Stevens Point, Wisconsin, Förenta staterna, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Summit, Wisconsin, Förenta staterna, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, Förenta staterna, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
West Allis, Wisconsin, Förenta staterna, 53227
- Aurora West Allis Medical Center
-
West Bend, Wisconsin, Förenta staterna, 53095
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
Weston, Wisconsin, Förenta staterna, 54476
- Marshfield Medical Center - Weston
-
-
-
-
Alberta
-
Calgary, Alberta, Kanada, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
-
-
Ontario
-
Toronto, Ontario, Kanada, M5G 2M9
- University Health Network-Princess Margaret Hospital
-
-
Quebec
-
Montreal, Quebec, Kanada, H3H 2R9
- The Research Institute of the McGill University Health Centre (MUHC)
-
Montreal, Quebec, Kanada, H1T 2M4
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
-
Québec, Quebec, Kanada, G1R 2J6
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
-
Sherbrooke, Quebec, Kanada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
-
-
Saskatchewan
-
Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre
-
Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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. |
Given PO Undergo external beam radiation therapy
Andra namn:
|
|
Experimentell: 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. |
Undergo external beam radiation therapy
Andra namn:
Given PO
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)
Tidsram: 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:
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of Participants With Undetectable PSA (< 0.1) and Non-castrate Testosterone (≥ 50 ng/dl) at One and Three Years
Tidsram: One and three years
|
One and three years
|
|
|
Percentage of Participants Alive (Overall Survival)
Tidsram: 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))
Tidsram: 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))
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Felix Y Feng, NRG Oncology
Publikationer och användbara länkar
Allmänna publikationer
- Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.
- Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part III: Salvage Therapy After Radiotherapy or Focal Therapy, Pelvic Nodal Recurrence and Oligometastasis, and Future Directions. J Urol. 2024 Apr;211(4):526-532. doi: 10.1097/JU.0000000000003890. Epub 2024 Feb 29.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Genitala neoplasmer, manliga
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Genitala sjukdomar, manliga
- Prostatasjukdomar
- Manliga urogenitala sjukdomar
- Prostatiska neoplasmer
- Fysiska fenomen
- Organisationer
- Hälsovårdsekonomi och organisationer
- Strålning
- Kongresser som ämne
- apalutamid
Andra studie-ID-nummer
- NRG-GU006
- U10CA180868 (U.S.S. NIH-anslag/kontrakt)
- NRG-GU006 (Annan identifierare: CTEP)
- NCI-2017-01268 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- NRG-GU006 (Annan identifierare: NRG Oncology)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .