S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy

October 8, 2021 updated by: Southwest Oncology Group

Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare the survival and progression-free survival of patients with hormone-refractory stage IV prostate cancer and bone metastases treated with docetaxel and prednisone combined with either atrasentan vs placebo.

Secondary

  • Compare pain progression of patients treated with these regimens.
  • Compare the qualitative and quantitative toxicity of these regimens in these patients.
  • Compare the quality of life, in terms of palliation of metastatic bone pain and improvement in functional status, of patients treated with these regimens.
  • Compare prostate-specific antigen (PSA) response rates in patients treated with these regimens.
  • Compare objective response in patients with measurable disease treated with these regimens.
  • Determine whether a 30% reduction in PSA and the slope of PSA from baseline to 3 months is a surrogate marker for survival in patients treated with these regimens.
  • Correlate PSA progression with clinical progression and death in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease progression (measurable or non-measurable disease progression vs prostate-specific antigen progression only), use of bisphosphonates at study entry (yes vs no), worst pain, measured by the Brief Pain Inventory "pain" scale (< grade 4 vs ≥ grade 4), and extraskeletal metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks in the absence of disease progression* or unacceptable toxicity.
  • Arm II: Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks in the absence of disease progression* or unacceptable toxicity.

NOTE: *Patients with PSA progression alone will be allowed to continue treatment

Quality of life is assessed at baseline, before courses 4, 7, and 10, and then after completion of study treatment.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 years from study entry.

PROJECTED ACCRUAL: A total of 930 patients will be accrued for this study within 4 years.

Study Type

Interventional

Enrollment (Actual)

1038

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Providence Cancer Center at Providence Hospital
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Regional Hospital Cancer Center
      • Fairbanks, Alaska, United States, 99701
        • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5499
        • Mayo Clinic Scottsdale
      • Tucson, Arizona, United States, 85724-5024
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
    • California
      • Castro Valley, California, United States, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, United States, 94546
        • Eden Medical Center
      • Castro Valley, California, United States, 94546
        • Valley Medical Oncology Consultants - Castro Valley
      • Fremont, California, United States, 94538
        • Valley Medical Oncology
      • Fresno, California, United States, 93720
        • Cancer Care Associates
      • Glendale, California, United States, 91204
        • Glendale Memorial Hospital Comprehensive Cancer Center
      • La Jolla, California, United States, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • Los Angeles, California, United States, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Martinez, California, United States, 94553-3156
        • Contra Costa Regional Medical Center
      • Marysville, California, United States, 95901
        • Tibotec Therapeutics - Division of Ortho Biotech Products, LP
      • Monterey, California, United States, 93940
        • Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
      • Mountain View, California, United States, 94040
        • El Camino Hospital Cancer Center
      • Mountain View, California, United States, 94040
        • Camino Medical Group - Treatment Center
      • Oakland, California, United States, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, United States, 94602
        • Highland General Hospital
      • Oakland, California, United States, 94609
        • Larry G Strieff MD Medical Corporation
      • Oakland, California, United States, 94609
        • CCOP - Bay Area Tumor Institute
      • Oakland, California, United States, 94609
        • Bay Area Breast Surgeons, Incorporated
      • Oakland, California, United States, 94609
        • Tom K Lee, Incorporated
      • Palm Springs, California, United States, 92262
        • Desert Regional Medical Center Comprehensive Cancer Center
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation
      • Pismo Beach, California, United States, 93449
        • PCR Oncology
      • Pleasanton, California, United States, 94588
        • Valley Care Medical Center
      • Pleasanton, California, United States, 94588
        • Valley Medical Oncology Consultants - Pleasanton
      • Rancho Mirage, California, United States, 92270
        • Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • Salinas, California, United States, 93901
        • Salinas Valley Memorial Hospital
      • San Pablo, California, United States, 94806
        • Doctors Medical Center - San Pablo Campus
      • Truckee, California, United States, 96161
        • Tahoe Forest Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center at UC Health Sciences Center
      • Aurora, Colorado, United States, 80012
        • Aurora Presbyterian Hospital
      • Boulder, Colorado, United States, 80301-9019
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
      • Denver, Colorado, United States, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, United States, 80204
        • St. Anthony Central Hospital
      • Denver, Colorado, United States, 80218
        • St. Joseph Hospital
      • Denver, Colorado, United States, 80224-2522
        • CCOP - Colorado Cancer Research Program
      • Edwards, Colorado, United States, 81632
        • Shaw Regional Cancer Center
      • Englewood, Colorado, United States, 80110
        • Swedish Medical Center
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, United States, 80528
        • Front Range Cancer Specialists
      • Glenwood Springs, Colorado, United States, 81601
        • Valley View Hospital Cancer Center
      • Grand Junction, Colorado, United States, 81502
        • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Hope Cancer Care Center at Longmont United Hospital
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Montrose, Colorado, United States, 81401
        • Montrose Memorial Hospital Cancer Center
      • Pueblo, Colorado, United States, 81004
        • St. Mary - Corwin Regional Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, United States, 80033
        • Exempla Lutheran Medical Center
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Praxair Cancer Center at Danbury Hospital
      • Hartford, Connecticut, United States, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
      • Manchester, Connecticut, United States, 06040
        • Manchester Memorial Hospital
      • Middletown, Connecticut, United States, 06457
        • Middlesex Hospital Cancer Center
      • Torrington, Connecticut, United States, 06790
        • Connecticut Oncology & Hematology - Torrington
    • Delaware
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center - Washington, DC
      • Washington, District of Columbia, United States, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center Cancer Center
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Leesburg, Florida, United States, 34788
        • Cancer Centers of Central Florida, PA
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami
      • Orange Park, Florida, United States, 32073
        • Integrated Community Oncology Network - Orange Park
      • Orlando, Florida, United States, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • Pensacola, Florida, United States, 32514
        • West Florida Cancer Institute at West Florida Hospital - Pensacola
      • Titusville, Florida, United States, 32796
        • Space Coast Medical Associates
    • Georgia
      • Athens, Georgia, United States, 30607
        • Northeast Georgia Cancer Care, LLC - Medical Oncology
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30342-1611
        • Northside Hospital Cancer Center
      • Atlanta, Georgia, United States, 30342-1701
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, United States, 30342
        • CCOP - Atlanta Regional
      • Augusta, Georgia, United States, 30912
        • MBCCOP - Medical College of Georgia Cancer Center
      • Austell, Georgia, United States, 30106
        • WellStar Cobb Hospital
      • Decatur, Georgia, United States, 30033
        • Charles B. Eberhart Cancer Center at DeKalb Medical Center
      • Lawrenceville, Georgia, United States, 30045
        • Gwinnett Medical Center
      • Marietta, Georgia, United States, 30060
        • Kennestone Cancer Center at Wellstar Kennestone Hospital
      • Riverdale, Georgia, United States, 30274-2600
        • Southern Regional Medical Center
      • Rome, Georgia, United States, 30165
        • Harbin Clinic Cancer Center - Medical Oncology
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Kapiolani Medical Center at Pali Momi
      • Honolulu, Hawaii, United States, 96813
        • Cancer Research Center of Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96813
        • OnCare Hawaii, Incorporated - Lusitana
      • Honolulu, Hawaii, United States, 96813
        • Queen's Cancer Institute at Queen's Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital, Incorporated
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Medical Center - East
      • Honolulu, Hawaii, United States, 96817
        • OnCare Hawaii, Incorporated - Kuakini
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
      • Wailuku, Hawaii, United States, 96793
        • Maui Memorial Medical Center
      • Wailuku, Hawaii, United States, 96793
        • Pacific Cancer Institute - Maui
    • Idaho
      • Boise, Idaho, United States, 83712
        • Mountain States Tumor Institute at St. Luke's Regional Medical Center
    • Illinois
      • Alton, Illinois, United States, 62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Cancer Care Center
      • Chicago, Illinois, United States, 60612-7243
        • University of Illinois Cancer Center
      • Chicago, Illinois, United States, 60608
        • Mount Sinai Hospital Medical Center
      • Chicago, Illinois, United States, 60657
        • Creticos Cancer Center at Advocate Illinois Masonic Medical Center
      • Chicago, Illinois, United States, 60631
        • Resurrection Medical Center
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Elgin, Illinois, United States, 60123
        • Sherman Hospital
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Radiation Oncology
      • Elmhurst, Illinois, United States, 60126
        • Elmhurst Memorial Hospital
      • Evanston, Illinois, United States, 60201-1781
        • Evanston Hospital
      • Freeport, Illinois, United States, 61032
        • Leonard C. Ferguson Cancer Center
      • Harvey, Illinois, United States, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Hines, Illinois, United States, 60141
        • Veterans Affairs Medical Center - Hines
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Kankakee, Illinois, United States, 60901
        • Provena St. Mary's Regional Cancer Center - Kankakee
      • La Grange, Illinois, United States, 60525
        • La Grange Memorial Hospital
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Mount Vernon, Illinois, United States, 62864
        • Good Samaritan Regional Health Center
      • Naperville, Illinois, United States, 60540
        • Edward Hospital Cancer Center
      • Naperville, Illinois, United States, 60540
        • Hematology Oncology Consultants - Naperville
      • Rockford, Illinois, United States, 61104-2315
        • Swedish-American Regional Cancer Center
      • Springfield, Illinois, United States, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
      • Winfield, Illinois, United States, 60190
        • Central Dupage Cancer Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Bloomington, Indiana, United States, 47403
        • Bloomington Hospital Regional Cancer Institute
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Goshen, Indiana, United States, 46526
        • Center for Cancer Care at Goshen General Hospital
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • William N. Wishard Memorial Hospital
      • Indianapolis, Indiana, United States, 46202
        • Veterans Affairs Medical Center - Indianapolis
      • Kokomo, Indiana, United States, 46904
        • Howard Community Hospital
      • La Porte, Indiana, United States, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Lafayette, Indiana, United States, 47904
        • Clarian Arnett Cancer Care
      • Michigan City, Indiana, United States, 46360
        • Saint Anthony Memorial Health Centers
      • Muncie, Indiana, United States, 47303
        • Medical Consultants, PC at Ball Memorial Cancer Center
      • Munster, Indiana, United States, 46321
        • Community Hospital
      • Richmond, Indiana, United States, 47374
        • Reid Hospital & Health Care Services
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, United States, 46617
        • Saint Joseph Regional Medical Center
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic, PC
      • Bettendorf, Iowa, United States, 52722
        • Hematology Oncology Associates of the Quad Cities
      • Cedar Rapids, Iowa, United States, 52402
        • St. Luke's Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Cedar Rapids, Iowa, United States, 52402
        • Iowa Blood and Cancer Care
      • Clive, Iowa, United States, 50325
        • Medical Oncology and Hematology Associates - West Des Moines
      • Council Bluffs, Iowa, United States, 51503
        • Heartland Oncology and Hematology
      • Davenport, Iowa, United States, 52804
        • Genesis Medical Center - West Campus
      • Davenport, Iowa, United States, 52803
        • Genesis Regional Cancer Center at Genesis Medical Center
      • Des Moines, Iowa, United States, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, United States, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50307
        • Mercy Capitol Hospital
      • Ottumwa, Iowa, United States, 52501
        • McCreery Cancer Center at Ottumwa Regional
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center - Sioux City
      • Waterloo, Iowa, United States, 50702
        • Covenant Cancer Treatment Center
      • Waterloo, Iowa, United States, 50701
        • Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
    • Kansas
      • Anthony, Kansas, United States, 67003
        • Hospital District Sixth of Harper County
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kansas City, Kansas, United States, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, United States, 67901
        • Southwest Medical Center
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas, PA - Newton
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's Hospital - South
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas, PA - Salina
      • Salina, Kansas, United States, 67401
        • Tammy Walker Cancer Center at Salina Regional Health Center
      • Shawnee Mission, Kansas, United States, 66204
        • Shawnee Mission Medical Center
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Cancer Center
      • Topeka, Kansas, United States, 66606
        • St. Francis Comprehensive Cancer Center
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, United States, 67214
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, United States, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Louisville, Kentucky, United States, 40292
        • James Graham Brown Cancer Center at University of Louisville
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center - Baton Rouge
      • Baton Rouge, Louisiana, United States, 70806
        • Pennington Cancer Center at Baton Rouge General
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, United States, 70112
        • Medical Center of Louisiana - New Orleans
      • Shreveport, Louisiana, United States, 71105
        • Highland Clinic
      • Shreveport, Louisiana, United States, 71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center Cancer Center
      • Easton, Maryland, United States, 21601
        • Shore Regional Cancer Center at Memorial Hospital - Easton
      • Elkton, Maryland, United States, 21921
        • Union Hospital Cancer Program at Union Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University Cancer Research Center
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic Medical Center - Burlington
      • Framingham, Massachusetts, United States, 01702
        • Metrowest Medical Center - Framingham Union Hospital
      • Springfield, Massachusetts, United States, 01199
        • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, United States, 48109-0942
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Battle Creek, Michigan, United States, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, United States, 49307
        • Mecosta County Medical Center
      • Dearborn, Michigan, United States, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Detroit, Michigan, United States, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Escanaba, Michigan, United States, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, United States, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, United States, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, United States, 49201
        • Foote Memorial Hospital
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
      • Lambertville, Michigan, United States, 48144
        • Haematology-Oncology Associates of Ohio and Michigan, PC
      • Lansing, Michigan, United States, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, United States, 48154
        • St. Mary Mercy Hospital
      • Marquette, Michigan, United States, 49855
        • Upper Michigan Cancer Center at Marquette General Hospital
      • Monroe, Michigan, United States, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital - Monroe
      • Mount Clemens, Michigan, United States, 48043
        • Clemens Regional Medical Center
      • Muskegon, Michigan, United States, 49443
        • Mercy General Health Partners
      • Pontiac, Michigan, United States, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, United States, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
      • Southfield, Michigan, United States, 48075
        • Providence Cancer Institute at Providence Hospital - Southfield Campus
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Warren, Michigan, United States, 48093
        • St. John Macomb Hospital
      • Wyoming, Michigan, United States, 49519
        • Metro Health Hospital
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • MeritCare Bemidji
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, United States, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, United States, 55805
        • Miller - Dwan Medical Center
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fergus Falls, Minnesota, United States, 56537
        • Fergus Falls Medical Group, PA
      • Fridley, Minnesota, United States, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Minneapolis, Minnesota, United States, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Robbinsdale, Minnesota, United States, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Willmar Cancer Center at Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Cancer Clinic
      • Jackson, Mississippi, United States, 39216
        • Veterans Affairs Medical Center - Jackson
      • Pascagoula, Mississippi, United States, 39581
        • Regional Cancer Center at Singing River Hospital
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Chesterfield, Missouri, United States, 63017
        • Saint Luke's Hospital
      • Independence, Missouri, United States, 64050
        • Independence Regional Health Center
      • Joplin, Missouri, United States, 64804
        • Freeman Cancer Institute at Freeman Health System
      • Kansas City, Missouri, United States, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center - Hospital Hill
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Institute at Saint Luke's Hospital
      • Kansas City, Missouri, United States, 64114
        • St. Joseph Medical Center
      • Kansas City, Missouri, United States, 64116
        • Parvin Radiation Oncology
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology Oncology Associates, Incorporated
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, United States, 64068
        • Liberty Hospital
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Cancer Center
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, United States, 63141
        • Arch Medical Services, Incorporated at Center for Cancer Care and Research
      • Saint Louis, Missouri, United States, 63109
        • Midwest Hematology Oncology Group, Incorporated
      • Saint Louis, Missouri, United States, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, United States, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, United States, 59107-7000
        • Billings Clinic - Downtown
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, United States, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, United States, 59405-5309
        • Big Sky Oncology
      • Great Falls, Montana, United States, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Great Falls, Montana, United States, 59405
        • Frontier Cancer Center
      • Havre, Montana, United States, 59501
        • Northern Montana Hospital
      • Helena, Montana, United States, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, United States, 59801
        • Community Medical Center
      • Missoula, Montana, United States, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, United States, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, United States, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
      • Kearney, Nebraska, United States, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
      • North Platte, Nebraska, United States, 69103
        • Callahan Cancer Center at Great Plains Regional Medical Center
      • Omaha, Nebraska, United States, 68198-6805
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Nevada Cancer Research Foundation
      • Reno, Nevada, United States, 89502
        • Renown Institute for Cancer at Renown Regional Medical Center
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
      • Exeter, New Hampshire, United States, 03833
        • Center for Cancer Care at Exeter Hospital
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology - Hematology, PA - Hooksett
      • Laconia, New Hampshire, United States, 03246
        • Lakes Region General Hospital
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Flemington, New Jersey, United States, 08822
        • Hunterdon Regional Cancer Center at Hunterdon Medical Center
      • Marlton, New Jersey, United States, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • Neptune, New Jersey, United States, 07754-0397
        • Jersey Shore Cancer Center at Jersey Shore University Medical Center
      • Ridgewood, New Jersey, United States, 07450
        • Valley Hospital - Ridgewood
      • Somerville, New Jersey, United States, 08876
        • Somerset Medical Center
      • Sparta, New Jersey, United States, 07871
        • Frederick R. and Betty M. Smith Cancer Treatment Center
      • Voorhees, New Jersey, United States, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
      • Voorhees, New Jersey, United States, 08043
        • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    • New York
      • Bronx, New York, United States, 10466
        • Our Lady of Mercy Medical Center Comprehensive Cancer Center
      • Brooklyn, New York, United States, 11209
        • Veterans Affairs Medical Center - Brooklyn
      • Buffalo, New York, United States, 14215
        • Veterans Affairs Medical Center - Buffalo
      • Cooperstown, New York, United States, 13326
        • Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
      • East Syracuse, New York, United States, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Elmira, New York, United States, 14905
        • Falck Cancer Center at Arnot Ogden Medical Center
      • Mount Kisco, New York, United States, 10549
        • Northern Westchester Hospital
      • New York, New York, United States, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Rochester, New York, United States, 14623
        • Interlakes Oncology/Hematology PC
      • Staten Island, New York, United States, 10305
        • Nalitt Cancer Institute at Staten Island University Hospital
      • Stony Brook, New York, United States, 11794-9446
        • Stony Brook University Cancer Center
      • Syracuse, New York, United States, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Asheboro, North Carolina, United States, 27203-5400
        • Randolph Hospital
      • Asheville, North Carolina, United States, 28801
        • Mission Hospitals - Memorial Campus
      • Burlington, North Carolina, United States, 27216
        • Alamance Cancer Center at Alamance Regional Medical Center
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Durham, North Carolina, United States, 27705
        • Veterans Affairs Medical Center - Durham
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center - Goldsboro
      • Greensboro, North Carolina, United States, 27403-1198
        • Moses Cone Regional Cancer Center at Wesley Long Community Hospital
      • Kinston, North Carolina, United States, 28501
        • Kinston Medical Specialists
      • Reidsville, North Carolina, United States, 27320
        • Annie Penn Cancer Center
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
      • Washington, North Carolina, United States, 27889
        • Marion L. Shepard Cancer Center at Beaufort County Hospital
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, United States, 58502
        • St. Alexius Medical Center Cancer Center
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, United States, 58122
        • MeritCare Broadway
      • Fargo, North Dakota, United States, 58103
        • Dakota Cancer Institute at Dakota Clinic - South University
      • Minot, North Dakota, United States, 58701
        • Trinity Cancercare Center
    • Ohio
      • Akron, Ohio, United States, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Bowling Green, Ohio, United States, 43402
        • Wood County Oncology Center
      • Cincinnati, Ohio, United States, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Cincinnati, Ohio, United States, 45220
        • Veterans Affairs Medical Center - Cincinnati
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Cancer Care Center at MetroHealth Medical Center
      • Clyde, Ohio, United States, 43410
        • North Coast Cancer Care - Clyde
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, United States, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, United States, 45405
        • Grandview Hospital
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, United States, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, United States, 45420
        • CCOP - Dayton
      • Elyria, Ohio, United States, 44035
        • Hematology Oncology Center
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Medical Associates
      • Franklin, Ohio, United States, 45005-1066
        • Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Wayne Hospital
      • Kettering, Ohio, United States, 45429
        • Charles F. Kettering Memorial Hospital
      • Lima, Ohio, United States, 45801
        • St. Rita's Medical Center
      • Maumee, Ohio, United States, 43537
        • St. Luke's Hospital
      • Maumee, Ohio, United States, 43537-1839
        • Northwest Ohio Oncology Center
      • Norwalk, Ohio, United States, 44857
        • Fisher-Titus Medical Center
      • Oregon, Ohio, United States, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic - Oregon
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care, Incorporated
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital
      • Toledo, Ohio, United States, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, United States, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, United States, 43623
        • St. Anne Mercy Hospital
      • Troy, Ohio, United States, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
      • Wilmington, Ohio, United States, 45177
        • Clinton Memorial Hospital
      • Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
        • United States Air Force Medical Center - Wright-Patterson
      • Xenia, Ohio, United States, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Cleo Craig Cancer Research Clinic
    • Oregon
      • Coos Bay, Oregon, United States, 97420
        • Bay Area Hospital
      • Milwaukie, Oregon, United States, 97222
        • Providence Milwaukie Hospital
      • Portland, Oregon, United States, 97216
        • Adventist Medical Center
      • Portland, Oregon, United States, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, United States, 97232
        • Kaiser Permanente Health Care - Portland
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, United States, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Easton, Pennsylvania, United States, 18042
        • Easton Regional Cancer Center at Easton Hospital
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Hazleton Cancer Center
      • Paoli, Pennsylvania, United States, 19301-1792
        • Cancer Center of Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224-1791
        • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Cancer Center at Guthrie Clinic Sayre
      • Scranton, Pennsylvania, United States, 18508
        • Hematology and Oncology Associates of Northeastern Pennsylvania
      • State College, Pennsylvania, United States, 16803
        • Mount Nittany Medical Center
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group - Scenery Park
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Cancer Center at Lankenau Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - Main Line Health
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Cancer Center
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Florence, South Carolina, United States, 29501
        • McLeod Regional Medical Center
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Oncology Services of Aberdeen
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center, PC
      • Sioux Falls, South Dakota, United States, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Cookeville, Tennessee, United States, 38501
        • Cookeville Regional Medical Center
      • Kingsport, Tennessee, United States, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
      • Memphis, Tennessee, United States, 38104
        • Veterans Affairs Medical Center - Memphis
      • Memphis, Tennessee, United States, 38104
        • University of Tennessee Cancer Institute - Memphis
    • Texas
      • Amarillo, Texas, United States, 79106
        • Harrington Cancer Center
      • Bryan, Texas, United States, 77802
        • St. Joseph Regional Cancer Center
      • Dallas, Texas, United States, 75216
        • Veterans Affairs Medical Center - Dallas
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Fort Sam Houston, Texas, United States, 78234-6200
        • Brooke Army Medical Center
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
      • Houston, Texas, United States, 77030
        • Methodist Hospital
      • Houston, Texas, United States, 77030
        • Veterans Affairs Medical Center - Houston
      • Houston, Texas, United States, 77030
        • Baylor University Medical Center - Houston
      • Houston, Texas, United States, 77030
        • St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
      • Lackland Air Force Base, Texas, United States, 78236
        • Wilford Hall Medical Center
      • Lubbock, Texas, United States, 79415-3364
        • UMC Southwest Cancer and Research Center
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy and Research Center
      • San Antonio, Texas, United States, 78209
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78229
        • University Hospital - San Antonio
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital
      • Cedar City, Utah, United States, 84720
        • Sandra L. Maxwell Cancer Center
      • Logan, Utah, United States, 84321
        • Logan Regional Hospital
      • Murray, Utah, United States, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute at University of Utah
      • Salt Lake City, Utah, United States, 84103
        • LDS Hospital
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Green Mountain Oncology Group
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Regional Medical Center
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology, Incorporated
      • Gloucester, Virginia, United States, 23061
        • Riverside Middle Peninsula Cancer Center
      • Lynchburg, Virginia, United States, 24501
        • Lynchburg Hematology-Oncology Clinic
      • Newport News, Virginia, United States, 23601
        • Peninsula Cancer Institute - Newport News Office
      • Norton, Virginia, United States, 24273
        • Southwest Virginia Regional Cancer Center at Wellmonth Health
      • Richmond, Virginia, United States, 23249
        • Veterans Affairs Medical Center - Richmond
      • Richmond, Virginia, United States, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center
      • Williamsburg, Virginia, United States, 23185
        • Peninsula Cancer Institute - Williamsburg Office
    • Washington
      • Auburn, Washington, United States, 98002
        • Auburn Regional Center for Cancer Care
      • Bellingham, Washington, United States, 98225
        • St. Joseph Cancer Center
      • Bremerton, Washington, United States, 98310
        • Olympic Hematology and Oncology
      • Centralia, Washington, United States, 98531-9027
        • Providence Centralia Hospital
      • Federal Way, Washington, United States, 98003
        • St. Francis Hospital
      • Kennewick, Washington, United States, 99336
        • Columbia Basin Hematology
      • Kirkland, Washington, United States, 98033
        • Cascade Cancer Center at Evergreen Hospital Medical Center
      • Olympia, Washington, United States, 98506-5166
        • Providence St. Peter Hospital Regional Cancer Center
      • Poulsbo, Washington, United States, 98370
        • Harrison Poulsbo Hematology and Onocology
      • Puyallup, Washington, United States, 98372
        • Good Samaritan Cancer Center
      • Renton, Washington, United States, 98055
        • Valley Medical Center
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, United States, 98104
        • Minor and James Medical, PLLC
      • Seattle, Washington, United States, 98112
        • Group Health Central Hospital
      • Seattle, Washington, United States, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, United States, 98122
        • Polyclinic First Hill
      • Seattle, Washington, United States, 98195
        • University Cancer Center at University of Washington Medical Center
      • Seattle, Washington, United States, 98104
        • Pacific Medical Center
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - Spokane South
      • Spokane, Washington, United States, 99218
        • Evergreen Hematology and Oncology, PS
      • Spokane, Washington, United States, 99204-2967
        • Rockwood Clinic Cancer Treatment Center
      • Tacoma, Washington, United States, 98405-3004
        • Franciscan Cancer Center at St. Joseph Medical Center
      • Tacoma, Washington, United States, 98405
        • Allenmore Hospital
      • Tacoma, Washington, United States, 98405
        • CCOP - Northwest
      • Tacoma, Washington, United States, 98405
        • MultiCare Regional Cancer Center at Tacoma General Hospital
      • Tacoma, Washington, United States, 98499
        • St. Clare Hospital
      • Vancouver, Washington, United States, 98668
        • Southwest Washington Medical Center Cancer Center
      • Wenatchee, Washington, United States, 98801-2028
        • Wenatchee Valley Medical Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • West Virginia University Health Sciences Center - Charleston
      • Parkersburg, West Virginia, United States, 26102
        • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
      • Wheeling, West Virginia, United States, 26003
        • Schiffler Cancer Center at Wheeling Hospital
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Memorial Hospital
      • Appleton, Wisconsin, United States, 54911-3496
        • Fox Valley Hematology and Oncology - East Grant Street
      • Chippewa Falls, Wisconsin, United States, 54729
        • Marshfield Clinic - Chippewa Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Care at Regional Cancer Center
      • Elkhorn, Wisconsin, United States, 53121
        • Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
      • Franklin, Wisconsin, United States, 53132
        • Oncology Alliance - Franklin
      • Glendale, Wisconsin, United States, 53212-1038
        • Oncology Alliance, SC - Milwaukee - East
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Johnson Creek, Wisconsin, United States, 53038
        • UW Cancer Center Johnson Creek
      • Kenosha, Wisconsin, United States, 53143
        • Oncology Alliance - Kenosha South
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Center for Cancer and Blood
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Manitowoc, Wisconsin, United States, 54221-1450
        • Holy Family Memorial Medical Center Cancer Care Center
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Saint Joseph's Hospital
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital and Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Medical Consultants, Limited
      • Milwaukee, Wisconsin, United States, 53215
        • Oncology Alliance, SC - Milwaukee - South
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic - Lakeland Center
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Rhinelander, Wisconsin, United States, 54501
        • Ministry Medical Group at Saint Mary's Hospital
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Clinic - Indianhead Center
      • Stevens Point, Wisconsin, United States, 54481
        • Saint Michael's Hospital Cancer Center
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Clinic - Wausau Center
      • Wausau, Wisconsin, United States, 54401
        • University of Wisconcin Cancer Center at Aspirus Wausau Hospital
      • Wauwatosa, Wisconsin, United States, 53226
        • Oncology Alliance, SC - Milwaukee - West
      • Weston, Wisconsin, United States, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Riverview UW Cancer Center at Riverview Hospital
    • Wyoming
      • Casper, Wyoming, United States, 82609
        • Rocky Mountain Oncology
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Stage IV disease (any T, any N, M1b)

      • Evidence of bone metastases by bone scan or MRI

  • Measurable or nonmeasurable disease

    • Soft tissue disease that has been irradiated within the past 2 months is not assessable as measurable disease

  • Hormone-refractory disease despite androgen deprivation and antiandrogen withdrawal, as defined by 1 of the following criteria:

    • Prostate-specific antigen (PSA) progression, defined as 3 consecutive rising PSA levels* taken ≥ 1 week apart

      • PSA ≥ 5 ng/mL NOTE: *If the third confirmatory PSA level is < the second level, the patient is considered eligible provided a fourth PSA level is > the second level
    • Progression of measurable disease
    • Progression of nonmeasurable disease by bone scan

  • Must have undergone surgical or medical (e.g., luteinizing hormone-releasing hormone [LHRH] agonist [e.g., leuprolide or goserelin] or LHRH antagonist therapy) castration

    • Patients who have undergone medical castration must continue LHRH agonist or antagonist therapy during study treatment
  • Must have completed 12 courses of blinding protocol treatment (atrasentan/placebo) AND stopped docetaxel for any reason (including completion of 12 courses) other than progressive disease
  • No symptomatic pleural effusion
  • No third space fluid accumulation (e.g., ascites)

  • No prior or concurrent brain metastases

    • Patients with clinical evidence of brain metastases must have a negative brain CT scan or MRI within the past 8 weeks

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-3* NOTE: For a performance status of 3, the cause must be due to pain secondary to bone metastases

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Fertile patients must use effective contraception
  • Able to take oral medication without crushing, dissolving, or chewing tablets
  • No major infection
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer in complete remission
  • No symptomatic sensory neuropathy ≥ grade 2
  • No history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No other significant, active medical illness that would preclude study treatment or survival

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No more than 1 prior systemic vaccine or biologic therapy

    • At least 4 weeks since prior vaccine or biologic therapy and recovered
  • No concurrent biological response modifiers
  • No concurrent prophylactic colony-stimulating factors

Chemotherapy

  • More than 2 years since prior adjuvant therapy with a single non-taxane-containing cytotoxic regimen
  • No prior cytotoxic chemotherapy for metastatic prostate cancer
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 6 weeks since prior bicalutamide or nilutamide AND has subsequent disease progression
  • At least 4 weeks since prior flutamide or ketoconazole AND has subsequent disease progression
  • Prior or concurrent megestrol for treatment of hot flashes allowed
  • No other concurrent corticosteroid or hormonal therapy unless continuing luteinizing hormone-releasing hormone treatment and/or bisphosphonate therapy

Radiotherapy

  • See Disease Characteristics
  • Prior samarium allowed
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to ≥ 30% of the bone marrow
  • No prior strontium
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • At least 3 weeks since prior surgery and recovered

Other

  • More than 4 weeks since prior investigational drugs

  • Concurrent bisphosphonates allowed provided therapy is started prior to study entry, dose is maintained during the first 12 weeks of study treatment, and patient meets criteria for disease progression

    • No initiation of bisphosphonates during the first 12 weeks of study treatment

  • No concurrent herbal medications or food supplements (e.g., PC-SPES, saw palmetto, Hypericum perforatum [St. John's wort])

    • Concurrent daily vitamins and calcium supplements allowed

  • At least 14 days since prior and no concurrent administration of any of the following:

    • Antibiotics (e.g., clarithromycin, erythromycin, troleandomycin, rifampin, rifabutin, and rifapentine)
    • Antifungals (e.g., itraconazole, ketoconazole, fluconazole [doses > 200 mg/day], and voriconazole)
    • Antidepressants (e.g., nefazodone and fluvoxamine)
    • Calcium channel blockers (e.g., verapamil, diltiazem)
    • Miscellaneous (e.g., amiodarone [no use within 6 months prior to study entry], grapefruit juice, bitter orange, or modafinil)
    • Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital, and oxcarbazepine)
    • Antibiotics (e.g., rifampin, rifabutin, and rifapentine)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I: placebo
Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
Other: placebo
Given orally
Drug: docetaxel
Docetaxel given IV and prednisone given orally
Other Names:
  • taxotere
Drug: prednisone
Docetaxel given IV and prednisone given orally
Other Names:
  • steroid
Experimental: Arm II: atrasentan hydrochloride
Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
Drug: docetaxel
Docetaxel given IV and prednisone given orally
Other Names:
  • taxotere
Drug: prednisone
Docetaxel given IV and prednisone given orally
Other Names:
  • steroid
Drug: atrasentan hydrochloride
Given orally
Other Names:
  • atrasentan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.
Time Frame: Up to 7 years after study opens
Measured from date of registration to date of death due to any cause. Patient last known to be alive are censored at date of last contact.
Up to 7 years after study opens
Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.
Time Frame: Up to 7 years after study opens
Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients without progression are censored at date of last contact. Disease progression is defined by confirmed bone disease progression, soft tissue or pain progression.
Up to 7 years after study opens

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Pain Progression Between the Two Study Arms.
Time Frame: Up to 52 weeks
Pain progression is defined as patients reporting an increase of at least two Worst Pain points, maintained for at least two consecutive assessments, increase to Level 3 (strong opioid) on the Pain Medication Log Analgesic Code for patients receiving Level 2 (weak opioid) analgesics at randomization, or an increase to Level 2 or 3 analgesics for patients receiving Level 0 or 1 analgesics at randomization.
Up to 52 weeks
Compare Qualitative and Quantitative Toxicity Between the Two Study Arms
Time Frame: Assessed every 3 weeks up to 52 weeks
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Assessed every 3 weeks up to 52 weeks
Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm.
Time Frame: Up to 7 years after study opens
PSA Partial Response: Greater than or equal to 50% reduction in baseline PSA. There must be no evidence of soft tissue progression, or confirmed none disease progression, or pain progression.
Up to 7 years after study opens
Compare Objective Responses Between the Two Treatment Groups in Patients With Measurable Disease as Defined by RECIST Criteria.
Time Frame: Up to 52 weeks
Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. PSA ≤ .2 ng/ml. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.
Up to 52 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)
Time Frame: up to 18 months study period
Pain palliation is the proportion of patients showing a two-point reduction in the Worst Pain score (WPS) maintained for two consecutive assessments with no increase in analgesic use. Increase in analgesic use is defined as an increase in Analgesic code Level to 2 (weak opioid) or 3 (strong opioid). Patients will be classified as pain palliated or not palliated. Patients with a WPS of "0" will be defined as "stable" if their WPS remains "0" for Weeks 7 and 10 with no increase in analgesic use, but they will not be categorized as responders. Pain palliation response is measured by BPI short form that has the following: yes/no question about pain today; 4 pain rating questions (worst pain, least pain, average pain, and current pain); pain medications and pain relief; 7 items addressing effect of pain on functioning. For patients who continue to receive treatment beyond 12 treatment cycles, the Worst Pain item is measured by Pain Medication Log and Pain Assessment
up to 18 months study period
Number of Patients With a Change in Functional Status
Time Frame: up to 18 months study period
Functional status will be measured with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index. The FACT-P also addresses four general domains of QOL (physical, functional, emotional, and social well-being subscales) as well as symptom concerns associated with prostate cancer and its treatment.
up to 18 months study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Maha Hadi A. Hussain, MD, University of Michigan Rogel Cancer Center
  • Study Chair: David I. Quinn, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 22, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000439434
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0421 (Other Identifier: SWOG)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://swog.org/Visitors/Download/Policies/Policy43.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe