Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer

September 13, 2023 updated by: Alliance for Clinical Trials in Oncology

Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

Study Overview

Detailed Description

Patients are randomized to one of two treatment groups: enzalutamide or enzalutamide, abiraterone and prednisone. Treatment will continue until disease progression or unacceptable toxicity. Patients are followed for clinical outcomes for a maximum of 5 years post study treatment. The primary and secondary objectives are described below.

  1. Primary Objective:

    To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer (CRPC) treated with either enzalutamide only or enzalutamide with abiraterone and prednisone

  2. Secondary Objectives:

    • To assess the grade 3 or higher toxicity profile and compare safety by treatment arm.
    • To assess and compare post-treatment prostate-specific antigen (PSA) declines by treatment arm.
    • To compare radiographic progression free survival defined by Prostate Cancer Working Group 2 (PCWG2), and objective response rate, by treatment arm.
    • To test for radiographic progression free survival (rPFS) treatment interaction in predicting overall survival.
    • To assess pre- and post-treatment measures of tumor burden and bone activity using sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT) and technetium (Tc) methylene diphosphonate (MDP) bone scintigraphy and correlate these measures with overall survival.
    • To develop and validate prognostic and predictive models of overall survival that include baseline clinical and molecular markers.

Study Type

Interventional

Enrollment (Actual)

1311

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

    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA-Vancouver Cancer Centre
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • The Moncton Hospital
      • Moncton, New Brunswick, Canada, E1C 8X3
        • The Vitalite Health Network - Dr Leon Richard Oncology Centre
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Atlantic Health Sciences Corporation-Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Doctor H. Bliss Murphy Cancer Centre
    • Ontario
      • Cambridge, Ontario, Canada, N1R 3G2
        • Cambridge Memorial Hospital
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre at Grand River Hospital
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • San Juan, Puerto Rico, 00936
        • San Juan City Hospital
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
      • San Juan, Puerto Rico, 00921-3201
        • San Juan Veterans Affairs Medical Center
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center PC-Providence
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
      • Tucson, Arizona, United States, 85704
        • University of Arizona Cancer Center-Orange Grove Campus
      • Tucson, Arizona, United States, 85719
        • University of Arizona Cancer Center-North Campus
      • Tucson, Arizona, United States, 85724
        • The University of Arizona Medical Center-University Campus
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Fowler Family Center for Cancer Care
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Veteran's Administration Medical Center
    • California
      • Anaheim, California, United States, 92807
        • Kaiser Permanente-Anaheim
      • Antioch, California, United States, 94531
        • Kaiser Permanente-Deer Valley Medical Center
      • Baldwin Park, California, United States, 91706
        • Kaiser Permanente-Baldwin Park
      • Bellflower, California, United States, 90706
        • Kaiser Permanente-Bellflower
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Fontana, California, United States, 92335
        • Kaiser Permanente Hospital
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont
      • Fresno, California, United States, 93720
        • Kaiser Permanente
      • Fresno, California, United States, 93701
        • University Oncology Associates
      • Fresno, California, United States, 93720
        • California Cancer Center - North Fresno
      • Greenbrae, California, United States, 94904
        • Marin Cancer Care Inc
      • Harbor City, California, United States, 90710
        • Kaiser Permanente - Harbor City
      • Irvine, California, United States, 92618
        • Kaiser Permanente-Irvine
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Los Angeles County-USC Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, United States, 90034
        • Kaiser Permanente-Cadillac
      • Marysville, California, United States, 95901
        • Fremont - Rideout Cancer Center
      • Modesto, California, United States, 95355
        • Memorial Medical Center
      • Modesto, California, United States, 95356
        • Kaiser Permanente-Modesto
      • Newport Beach, California, United States, 92663
        • USC Norris Oncology/Hematology-Newport Beach
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Health Care
      • Panorama City, California, United States, 91402
        • Kaiser Permanente - Panorama City
      • Paradise, California, United States, 95969
        • Feather River Cancer Center
      • Redwood City, California, United States, 94063
        • Kaiser Permanente-Redwood City
      • Richmond, California, United States, 94801
        • Kaiser Permanente-Richmond
      • Riverside, California, United States, 92505
        • Kaiser Permanente-Riverside
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, United States, 95823
        • Kaiser Permanente-South Sacramento
      • Sacramento, California, United States, 95825
        • Kaiser Permanente - Sacramento
      • Saint Helena, California, United States, 94574
        • Saint Helena Hospital
      • San Diego, California, United States, 92120
        • Kaiser Permanente-San Diego Zion
      • San Diego, California, United States, 92134
        • Naval Medical Center -San Diego
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Diego, California, United States, 92161
        • Veterans Administration-San Diego Medical Center
      • San Francisco, California, United States, 94121
        • Veterans Affairs Medical Center - San Francisco
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, United States, 94158
        • UCSF Medical Center-Mission Bay
      • San Francisco, California, United States, 94115
        • UCSF Medical Center-Mount Zion
      • San Jose, California, United States, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente San Leandro
      • San Marcos, California, United States, 92069
        • Kaiser Permanente-San Marcos
      • San Rafael, California, United States, 94903
        • Kaiser Permanente-San Rafael
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Cruz, California, United States, 95065
        • Palo Alto Medical Foundation-Santa Cruz
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente-Santa Rosa
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Stockton, California, United States, 95210
        • Kaiser Permanente-Stockton
      • Stockton, California, United States, 95204
        • Saint Joseph's Medical Center
      • Sunnyvale, California, United States, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Vacaville, California, United States, 95688
        • Kaiser Permanente Medical Center-Vacaville
      • Vallejo, California, United States, 94589
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente-Walnut Creek
      • Woodland Hills, California, United States, 91367
        • Kaiser Permanente
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, United States, 80909
        • Memorial Hospital Colorado Springs
      • Denver, Colorado, United States, 80205
        • Kaiser Permanente-Franklin
      • Durango, Colorado, United States, 81301
        • Southwest Oncology PC
      • Edwards, Colorado, United States, 81632
        • The Shaw Regional Cancer Center
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers-Lakewood
    • Connecticut
      • Greenwich, Connecticut, United States, 06830
        • Greenwich Hospital
      • Hartford, Connecticut, United States, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Middletown, Connecticut, United States, 06457
        • Middlesex Hospital
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology and Oncology Associates
      • Stamford, Connecticut, United States, 06904
        • Stamford Hospital/Bennett Cancer Center
      • West Haven, Connecticut, United States, 06516
        • Veterans Affairs Connecticut Healthcare System-West Haven Campus
    • Delaware
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants PA
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center -Washington DC
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist MD Anderson Cancer Center
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital Orlando
      • Orlando, Florida, United States, 32806
        • UF Cancer Center at Orlando Health
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Columbus, Georgia, United States, 31904
        • John B Amos Cancer Center
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center
      • Macon, Georgia, United States, 31201
        • Medical Center of Central Georgia
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Valdosta, Georgia, United States, 31602
        • South Georgia Medical Center/Pearlman Cancer Center
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
      • 'Aiea, Hawaii, United States, 96701
        • Hawaii Oncology Inc-Pali Momi
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, United States, 96817
        • Kuakini Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Island Urology
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care Inc-POB II
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Oncology Inc-POB I
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Oncology Inc-Kuakini
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
      • Lihue, Hawaii, United States, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Post Falls, Idaho, United States, 83854
        • Kootenai Cancer Center
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush - Copley Medical Center
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60608
        • Mount Sinai Hospital Medical Center
      • Chicago, Illinois, United States, 60640
        • Weiss Memorial Hospital
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Center of Decatur
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Geneva, Illinois, United States, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview, Illinois, United States, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Highland Park, Illinois, United States, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Hines, Illinois, United States, 60141
        • Hines Veterans Administration Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Quincy, Illinois, United States, 62301
        • Quincy Medical Group-Clinic
      • River Forest, Illinois, United States, 60305
        • West Suburban Medical Center
      • Rockford, Illinois, United States, 61108
        • OSF Saint Anthony Medical Center
      • Springfield, Illinois, United States, 62781
        • Memorial Medical Center
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Central Illinois Hematology Oncology Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne Medical Oncology and Hematology Inc-Parkview
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology and Hematology Inc - Jefferson Boulevard
      • Mishawaka, Indiana, United States, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • Munster, Indiana, United States, 46321
        • The Community Hospital
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • Westville, Indiana, United States, 46391
        • Michiana Hematology Oncology PC-Westville
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC-William R Bliss Cancer Center
      • Bettendorf, Iowa, United States, 52722
        • Hematology Oncology Associates-Quad Cities
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Clive, Iowa, United States, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, United States, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Davenport, Iowa, United States, 52803
        • Genesis Medical Center - East Campus
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Iowa City, Iowa, United States, 52246
        • Iowa City VA Healthcare System
      • Mason City, Iowa, United States, 50401
        • Mercy Medical Center - North Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
      • West Des Moines, Iowa, United States, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas - El Dorado
      • Emporia, Kansas, United States, 66801
        • Newman Regional Health
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Garden City, Kansas, United States, 67846
        • Saint Catherine Hospital
      • Great Bend, Kansas, United States, 67530
        • Saint Rose Ambulatory and Surgery Center
      • Hays, Kansas, United States, 67601
        • Hays Medical Center
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Kansas City, Kansas, United States, 66112
        • University of Kansas Cancer Center-West
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas-Kingman
      • Liberal, Kansas, United States, 67905
        • Cancer Center of Kansas-Liberal
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Olathe, Kansas, United States, 66061
        • Olathe Medical Center
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center-Overland Park
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's South Hospital
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Pittsburg, Kansas, United States, 66762
        • Via Christi Hospital-Pittsburg
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, United States, 67401
        • Salina Regional Health Center
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Topeka, Kansas, United States, 66606
        • Saint Francis Hospital and Medical Center - Topeka
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Wichita
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Saint Joseph Hospital East
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Christus Saint Frances Cabrini Hospital
      • Baton Rouge, Louisiana, United States, 70809
        • Ochsner Health Center-Summa
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology/Oncology Clinic LLP
      • Kenner, Louisiana, United States, 70065
        • Ochsner Medical Center Kenner
      • Metairie, Louisiana, United States, 70006
        • East Jefferson General Hospital
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center Jefferson
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
    • Maine
      • Augusta, Maine, United States, 04330
        • Harold Alfond Center for Cancer Care
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
      • Brewer, Maine, United States, 04412
        • Lafayette Family Cancer Center-EMMC
      • Rockport, Maine, United States, 04856
        • Penobscot Bay Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital
      • Olney, Maryland, United States, 20832
        • Montgomery General Hospital-Olney
      • Westminster, Maryland, United States, 21157
        • William E Kahlert Regional Cancer Center/Sinai Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Fitchburg, Massachusetts, United States, 01420
        • Simonds-Sinon Regional Cancer Center
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Escanaba, Michigan, United States, 49829
        • Green Bay Oncology - Escanaba
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, United States, 49503
        • Mercy Health Saint Mary's
      • Iron Mountain, Michigan, United States, 49801
        • Green Bay Oncology - Iron Mountain
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Livonia, Michigan, United States, 48154
        • Saint Mary Mercy Hospital
      • Reed City, Michigan, United States, 49677
        • Spectrum Health Reed City Hospital
      • Saginaw, Michigan, United States, 48601
        • Saint Mary's of Michigan
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Clinic North-Bemidgi
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • Saint Luke's Hospital of Duluth
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Edina, Minnesota, United States, 55435
        • Fairview-Southdale Hospital
      • Fergus Falls, Minnesota, United States, 56537
        • Lake Region Healthcare Corporation-Cancer Care
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Mankato, Minnesota, United States, 56001
        • Mayo Clinic Health Systems-Mankato
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55454
        • Health Partners Inc
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis Veterans Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Mississippi
      • Corinth, Mississippi, United States, 38834
        • The West Clinic - Corinth
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63703
        • Southeast Cancer Center
      • Chesterfield, Missouri, United States, 63017
        • Saint Luke's Hospital
      • Columbia, Missouri, United States, 65212
        • University of Missouri - Ellis Fischel
      • Creve Coeur, Missouri, United States, 63141
        • Barnes-Jewish West County Hospital
      • Jefferson City, Missouri, United States, 65109
        • Capital Region Medical Center-Goldschmidt Cancer Center
      • Kansas City, Missouri, United States, 64128
        • Kansas City Veterans Affairs Medical Center
      • Kansas City, Missouri, United States, 64131
        • The University of Kansas Cancer Center-South
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center
      • Kansas City, Missouri, United States, 64154
        • The University of Kansas Cancer Center-North
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Lee's Summit, Missouri, United States, 64064
        • The University of Kansas Cancer Center-Lee's Summit
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
    • Montana
      • Anaconda, Montana, United States, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • CHI Health Saint Francis
      • Kearney, Nebraska, United States, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Hematology and Oncology
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Cancer Center
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, United States, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, United States, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • New Hampshire Oncology Hematology PA-Concord
      • Dover, New Hampshire, United States, 03820
        • Wentworth-Douglass Hospital
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology Hematology PA-Hooksett
      • Laconia, New Hampshire, United States, 03246
        • LRGHealthcare-Lakes Region General Hospital
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
      • Manchester, New Hampshire, United States, 03102
        • Norris Cotton Cancer Center-Manchester
      • Nashua, New Hampshire, United States, 03063
        • Norris Cotton Cancer Center-Nashua
      • Nashua, New Hampshire, United States, 03060
        • Saint Joseph Hospital
      • Portsmouth, New Hampshire, United States, 03802
        • Portsmouth Regional Hospital
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Cancer Center at Basking Ridge
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Adminstration New Jersey Health Care System
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Mount Holly, New Jersey, United States, 08060
        • Virtua Memorial
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital-Luckow Pavilion
      • Voorhees, New Jersey, United States, 08043
        • Virtua Voorhees
      • Westwood, New Jersey, United States, 07675
        • Valley Health System-Hematology/Oncology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
      • Las Cruces, New Mexico, United States, 88011
        • Memorial Medical Center - Las Cruces
      • Santa Fe, New Mexico, United States, 87505
        • Christus Saint Vincent Regional Cancer Center
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
      • Bronx, New York, United States, 10467-2490
        • Montefiore Medical Center - Moses Campus
      • Bronx, New York, United States, 10468
        • Bronx Veterans Administration Medical Center
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
      • Brooklyn, New York, United States, 11203
        • Kings County Hospital
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Buffalo, New York, United States, 14215
        • Veterans Affairs Western New York Health Care System-Buffalo
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center Commack
      • Elmira, New York, United States, 14905
        • Arnot Ogden Medical Center/Falck Cancer Center
      • Harrison, New York, United States, 10604
        • Memorial Sloan-Kettering Cancer Center West Harrison
      • New Hyde Park, New York, United States, 11040
        • North Shore-LIJ Health System/Center for Advanced Medicine
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • New York, New York, United States, 10032
        • Columbia University/Herbert Irving Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rockville Centre, New York, United States, 11570
        • Memorial Sloan Kettering Cancer Center Rockville Centre
      • Sleepy Hollow, New York, United States, 10591
        • Memorial Sloan Kettering Cancer Center Sleepy Hollow
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Syracuse Veterans Administration Medical Center
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Randolph Hospital
      • Burlington, North Carolina, United States, 27215
        • Cone Health Cancer Center at Alamance Regional
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Charlotte, North Carolina, United States, 28207
        • Oncology Specialists of Charlotte
      • Charlotte, North Carolina, United States, 28262
        • Southern Oncology Specialists-Charlotte
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27705
        • Durham Veterans Affairs Medical Center
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
      • Huntersville, North Carolina, United States, 28078
        • Southern Oncology Specialists-Huntersville
      • Huntersville, North Carolina, United States, 28078
        • Lake Norman Hematology Oncology Specialists-Huntersville
      • Kernersville, North Carolina, United States, 27284
        • Novant Health Oncology Specialists-Kernersville
      • Kinston, North Carolina, United States, 28501
        • Kinston Medical Specialists PA
      • Matthews, North Carolina, United States, 28105
        • Novant Health Cancer Specialists-Matthews
      • Mooresville, North Carolina, United States, 28117
        • Lake Norman Hematology Oncology Specialists-Mooresville
      • Mount Airy, North Carolina, United States, 27030
        • Novant Health Oncology Specialists-Mount Airy
      • Reidsville, North Carolina, United States, 27320
        • Annie Penn Memorial Hospital
      • Salisbury, North Carolina, United States, 28144
        • Carolina Oncology Associates PA
      • Salisbury, North Carolina, United States, 28144
        • Veterans Administration Medical Center
      • Statesville, North Carolina, United States, 28625
        • Novant Health Oncology Specialists-Statesville
      • Thomasville, North Carolina, United States, 27360
        • Novant Health Oncology Specialists-Davidson County
      • Washington, North Carolina, United States, 27889
        • Marion L Shepard Cancer Center at Vidant Beaufort Hospital
      • Wilkesboro, North Carolina, United States, 28659
        • Novant Health Oncology Specialists-Wilkesboro
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Oncology Specialists
      • Winston-Salem, North Carolina, United States, 27103
        • Winston-Salem Health Care
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Clinic North-Fargo
      • Fargo, North Dakota, United States, 58122
        • Sanford Medical Center-Fargo
      • Grand Forks, North Dakota, United States, 58201
        • Altru Cancer Center
      • Minot, North Dakota, United States, 58701
        • Trinity Cancer Care Center
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Akron City Hospital/Cooper Cancer Center
      • Barberton, Ohio, United States, 44203
        • Summa Barberton Hospital
      • Beachwood, Ohio, United States, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Canton, Ohio, United States, 44708
        • Mercy Medical Center
      • Centerville, Ohio, United States, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Chardon, Ohio, United States, 44024
        • Geaugra Hospital
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati/Barrett Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Samaritan North Health Center
      • Elyria, Ohio, United States, 44035
        • Mercy Cancer Center-Elyria
      • Elyria, Ohio, United States, 44035
        • Hematology Oncology Center Incorporated
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, United States, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, United States, 45840
        • Orion Cancer Care
      • Independence, Ohio, United States, 44131
        • Cleveland Clinic Cancer Center Independence
      • Kettering, Ohio, United States, 45409
        • Greater Dayton Cancer Center
      • Mansfield, Ohio, United States, 44906
        • Cleveland Clinic Cancer Center Mansfield
      • Maumee, Ohio, United States, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Mayfield Heights, Ohio, United States, 44124
        • Ireland Cancer Center Landerbrook Health Center
      • Medina, Ohio, United States, 44256
        • Summa Health Center at Lake Medina
      • Mentor, Ohio, United States, 44060
        • Lake University Ireland Cancer Center
      • Middleburg Heights, Ohio, United States, 44130
        • Southwest General Health Center Ireland Cancer Center
      • Parma, Ohio, United States, 44129
        • University Hospitals Parma Medical Center
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care
      • Sandusky, Ohio, United States, 44870
        • Ireland Cancer Center at Firelands Regional Medical Center
      • Strongsville, Ohio, United States, 44136
        • Cleveland Clinic Cancer Center Strongsville
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, United States, 43614
        • University of Toledo
      • Wadsworth, Ohio, United States, 44281
        • University Hospitals Sharon Health Center
      • Warrensville Heights, Ohio, United States, 44122
        • South Pointe Hospital
      • West Chester, Ohio, United States, 45069
        • University Pointe
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
      • Westlake, Ohio, United States, 44145
        • UHHS-Westlake Medical Center
      • Westlake, Ohio, United States, 44145
        • UH-Seidman Cancer Center at Saint John Medical Center
      • Wooster, Ohio, United States, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
      • Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
        • Wright-Patterson Medical Center
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Cancer Centers of Southwest Oklahoma Research
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Hospital Oklahoma City
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Good Samaritan Hospital
      • Milwaukie, Oregon, United States, 97222
        • Providence Milwaukie Hospital
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, United States, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Northwest
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, United States, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Gettysburg, Pennsylvania, United States, 17325
        • Adams Cancer Center
      • Langhorne, Pennsylvania, United States, 19047
        • Saint Mary Medical and Regional Cancer Center
      • Natrona Heights, Pennsylvania, United States, 15065
        • Allegheny Valley Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Roper Hospital
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology Associates-Roper
      • Charleston, South Carolina, United States, 29406
        • Lowcountry Hematology Oncology PA-North Charleston
      • Charleston, South Carolina, United States, 29414
        • Bon Secours Saint Francis Hospital
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology Associates PA-St. Francis
      • Charleston, South Carolina, United States, 29414
        • Lowcountry Hematology Oncology PA-West Ashley
      • Easley, South Carolina, United States, 29640
        • Greenville Health System Cancer Institute-Easley
      • Greenville, South Carolina, United States, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, United States, 29601
        • Saint Francis Hospital
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Faris
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System Cancer Institute-Eastside
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Butternut
      • Greer, South Carolina, United States, 29650
        • Greenville Health System Cancer Institute-Greer
      • Lancaster, South Carolina, United States, 29720
        • Carolina Blood and Cancer Care Associates PA-Lancaster
      • Mount Pleasant, South Carolina, United States, 29464
        • Lowcountry Hematology Oncology PA-Mount Pleasant
      • Seneca, South Carolina, United States, 29672
        • Greenville Health System Cancer Institute-Seneca
      • Spartanburg, South Carolina, United States, 29307
        • Greenville Health System Cancer Institute-Spartanburg
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Avera Cancer Institute-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, 57104
        • Sanford Cancer Center-Oncology Clinic
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The West Clinic - Wolf River
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Fort Worth, Texas, United States, 76104
        • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Galveston, Texas, United States, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
      • League City, Texas, United States, 77573
        • UTMB Cancer Center at Victory Lakes
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Vermont
      • Burlington, Vermont, United States, 05405
        • University of Vermont College of Medicine
      • White River Junction, Vermont, United States, 05009
        • White River Junction Veteran Administration Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
      • Hampton, Virginia, United States, 23666
        • Virginia Oncology Associates-Hampton
      • Lynchburg, Virginia, United States, 24501
        • Lynchburg Hematology-Oncology Clinic
      • Martinsville, Virginia, United States, 24115
        • Memorial Hospital Of Martinsville
      • Mechanicsville, Virginia, United States, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, United States, 23114
        • Bon Secours Saint Francis Medical Center
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology Associates PC
    • Washington
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, United States, 98029
        • Swedish Cancer Institute-Issaquah
      • Poulsbo, Washington, United States, 98370
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Seattle, Washington, United States, 98104
        • Minor and James Medical PLLC
      • Seattle, Washington, United States, 98122-4307
        • Swedish Medical Center-First Hill
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • West Virginia University Charleston
      • Huntington, West Virginia, United States, 25702
        • Saint Mary's Medical Center
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Hospital and Cancer Center
      • Burlington, Wisconsin, United States, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Eau Claire, Wisconsin, United States, 54701
        • Mayo Clinic Health System-Eau Claire Clinic
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Eau Claire, Wisconsin, United States, 54701
        • Sacred Heart Hospital
      • Fond Du Lac, Wisconsin, United States, 54935
        • Saint Agnes Hospital/Agnesian Cancer Center
      • Germantown, Wisconsin, United States, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, United States, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, United States, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Janesville, Wisconsin, United States, 53547
        • Mercy Health System
      • Kenosha, Wisconsin, United States, 53142
        • Aurora Cancer Care-Kenosha South
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Madison, Wisconsin, United States, 53705
        • William S Middleton VA Medical Center
      • Manitowoc, Wisconsin, United States, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, United States, 54143
        • Vince Lombardi Cancer Clinic-Marinette
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Marshfield, Wisconsin, United States, 54449
        • Saint Joseph's Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and the Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Sinai Medical Center
      • Milwaukee, Wisconsin, United States, 53295
        • Zablocki Veterans Administration Medical Center
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic-Minocqua Center
      • Mukwonago, Wisconsin, United States, 53149
        • ProHealth D N Greenwald Center
      • Oconomowoc, Wisconsin, United States, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology - Oconto Falls
      • Oshkosh, Wisconsin, United States, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, United States, 53406
        • Aurora Cancer Care-Racine
      • Racine, Wisconsin, United States, 53405
        • Wheaton Franciscan Cancer Care - All Saints
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Clinic-Rice Lake Center
      • Sheboygan, Wisconsin, United States, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Sheboygan, Wisconsin, United States, 53081
        • HSHS Saint Nicholas Hospital
      • Stevens Point, Wisconsin, United States, 54481
        • Saint Michael's Hospital
      • Stevens Point, Wisconsin, United States, 54481
        • Marshfield Clinic Cancer Care at Saint Michael's Hospital
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology - Sturgeon Bay
      • Summit, Wisconsin, United States, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, United States, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waukesha, Wisconsin, United States, 53188
        • ProHealth Waukesha Memorial Hospital
      • Waukesha, Wisconsin, United States, 53188
        • Aurora Cancer Care-Waukesha
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center
      • Wauwatosa, Wisconsin, United States, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, United States, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, United States, 54476
        • Diagnostic and Treatment Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Aspirus UW Cancer Center

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

Description

Eligibility Criteria:

  1. Documentation of Disease - Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  2. Patients must have measurable or non-measurable disease:

    1. Measurable Disease - For visceral or extra nodal lesions to be considered measurable, they must be ≥ 10 mm in one dimension, using spiral CT. For lymph nodes to be considered measurable (ie, target or evaluable lesions), they must be ≥ 20 mm in at least one dimension, using spiral CT.
    2. Non-Measurable Disease - All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions. Lesions that are considered non-measurable include bone lesions (only).
    3. Patients with node only disease (ie, no presence of visceral, extra nodal lesions or bone lesions) must have node(s) that measure ≥ 15 mm in short axis.
  3. Progressive Disease - Patients must have progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy. For patients enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan. If the comparison scan is not available, the baseline scan report must reference the previous scan to document progression.

    1. PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen must have progression documented by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination such that at least the second of these rises is ≥ 4 weeks since last flutamide, bicalutamide or nilutamide.

      The PSA value at the screening should be ≥ 2 µg/L (2 ng/mL) .

    2. Soft tissue disease progression defined by the protocol
    3. Bone disease progression defined by the Prostate Cancer Working Group 2 (PCWG2) with two or more new lesions on bone scan
  4. Prior Treatment

    1. No treatment with prior taxane-based chemotherapy for metastatic disease

      • Patients who received prior taxane-based chemotherapy as neoadjuvant or adjuvant therapy for local disease, or who received taxane-based therapy in the PSA clinical (non-metastatic) state is allowable provided that the total duration of exposure was six cycles or less and chemotherapy was completed more than 6 months prior to registration
      • Taxane-based chemotherapy that was aborted due to allergic reactions or intolerance to chemotherapy and therefore received one cycle of prior therapy is allowable
    2. No prior enzalutamide, abiraterone or other novel antiandrogen or androgen synthesis inhibitor
    3. No treatment with any of the following for prostate cancer within 4 weeks prior to enrollment:

      • Hormonal therapy (e.g., androgen receptor [AR] antagonists, 5 alpha reductase inhibitors, estrogens) Note: Treatment with bicalutamide and nilutamide within 4 weeks prior to enrollment is not allowed. Treatment with flutamide within 4 weeks prior to enrollment is not allowed. Treatment with all other gonadotropin- releasing hormone (GnRH) analogues or antagonists is allowed.
      • Chemotherapy
      • Biologic therapy
      • Investigational therapy
      • Immunotherapy
    4. No use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment
    5. No use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment
    6. No prior use of ketoconazole for greater than 7 days
    7. No prior radiation therapy or radionuclide therapy for the treatment of metastasis within four weeks prior to enrollment
    8. Patients receiving bisphosphonate therapy or denosumab must have been on a stable dose for at least 4 weeks prior to enrollment
    9. Patients must maintain ongoing androgen deprivation therapy with a GnRH analogue, antagonist, or bilateral orchiectomy (i.e., surgical or medical castration)
  5. Patient History

    1. No known or suspected brain metastases (NOTE: patients with treated epidural disease are allowed)
    2. No planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
    3. No structurally unstable bone lesions suggesting impending fracture
    4. No history of seizure or any condition that may increase the patient's seizure risk (e.g., prior cortical stroke, significant brain trauma). No history of transient ischemic attack (TIA) within 12 months of enrollment
    5. No clinically significant cardiovascular disease including:

      • Myocardial infarction (MI) within 6 months
      • Uncontrolled angina within 3 months
      • Congestive heart failure (CHF) with New York Heart Association (NYHA) class 3 or 4, or patients with NYHA class 3 or 4 in the past, unless a screening echocardiogram (echo) or multigated acquisition scan (MUGA) performed within three months demonstrates an ejection fraction (EF) > 45%
      • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
      • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
      • Hypotension (systolic blood pressure [BP] < 86 mmHg) or bradycardia (< 50 bpm) at screening
      • Uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105 mmHg at screening)
    6. No gastrointestinal (GI) disorder that negatively affects absorption
    7. No major surgery within 4 weeks prior to enrollment
  6. Age and performance status

    1. Age ≥ 18 years of age
    2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    3. Asymptomatic or mildly symptomatic from prostate cancer
  7. Required Initial Laboratory Values

    1. Granulocytes ≥ 1,500/µL
    2. Platelet count ≥ 100,000/µL
    3. Hemoglobin ≥ 9 g/dL
    4. Creatinine ≤ 2 x upper limits of normal (ULN)
    5. Bilirubin ≤ 1.5 x ULN
    6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2 x ULN
    7. Albumin ≥ 3 g/dl
    8. Total testosterone ≤ 50 ng/dL (1.7 nmol/L)

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: (enzalutamide)
Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
Enzalutamide 160 mg daily, orally
Experimental: Arm B: (enzalutamide, abiraterone, prednisone)
Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
Enzalutamide 160 mg daily, orally
abiraterone 1000 mg daily, orally
prednisone 5 mg twice daily, orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 5 years post treatment
Overall survival is defined as the time from study registration to death due to any cause.
Up to 5 years post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Has Experienced at Least One Toxicity (Defined as a Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment)
Time Frame: Up to 5 years post treatment
The number of participants who has experienced at least one toxicity (defined as a grade 3 or higher adverse event deemed at least possibly related to treatment)
Up to 5 years post treatment
Decline in Prostate Specific Antigen (PSA)
Time Frame: Up to 5 years post treatment
Up to 5 years post treatment
Progression Free Survival (PFS)
Time Frame: Up to 5 years post treatment
Up to 5 years post treatment
Objective Response Rate
Time Frame: Up to 5 years post treatment
Up to 5 years post treatment
Radiographic Progression Free Survival (rPFS)
Time Frame: Up to 5 years post treatment
Up to 5 years post treatment
Tumor Burden and Bone Activity
Time Frame: Up to 5 years post treatment
Up to 5 years post treatment

Collaborators and Investigators

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

Investigators

  • Study Chair: Michael Morris, M.D., Memorial Sloan Kettering Cancer Center

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 (Actual)

January 22, 2014

Primary Completion (Actual)

November 2, 2018

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

September 20, 2013

First Posted (Estimated)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

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 Recurrent Prostate Cancer

Clinical Trials on enzalutamide

3
Subscribe