S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer
NCT ID: NCT01809691
Last Updated: 2025-12-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1313 participants
INTERVENTIONAL
2013-03-08
2025-09-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ADT + TAK-700
LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
TAK-700
300 mg, PO, twice daily
ADT + Bicalutamide
LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
Bicalutamide
50 mg, PO, q daily
Interventions
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TAK-700
300 mg, PO, twice daily
Bicalutamide
50 mg, PO, q daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum testosterone within institutional limits of normal.
* PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).
* DEXA scan within 2 years prior to registration.
* ECG within 42 days prior to registration and QTc interval ≤ 460 msec.
* LVEF within 42 days prior to registration and within institutional limits of normal.
* Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.
* Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.
* Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.
* Zubrod performance status of 0 - 2. Zubrod performance status 3 will be allowed if from bone pain only.
* ≥ 18 years of age.
* Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.
Exclusion Criteria
* No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.
* ≥ 6 months since completion of androgen deprivation therapy.
* Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.
* Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.
* ≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.
* Concurrent use of experimental therapy is not allowed.
* ≥ 30 days since prior medical castration for metastatic prostate cancer.
* If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.
* If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).
* Prior bilateral orchiectomy.
* Concurrent use of LHRH antagonists (e.g. Degarelix)
* Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
* Uncontrolled hypertension (defined as blood pressure \> 160 mmHg systolic and \> 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.
* Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.
* History of primary and secondary adrenal insufficiency.
* Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.
* Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
18 Years
MALE
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Neeraj Agarwal, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Veterans Administration Medical Center - Birmingham
Birmingham, Alabama, United States
University of Arizona Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Southern Arizona Veterans Affairs Health Center
Tucson, Arizona, United States
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States
Fowler Family Center for Cancer Care
Jonesboro, Arkansas, United States
Veteran's Administration Medical Center
Little Rock, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Mills - Peninsula Hospitals
Burlingame, California, United States
City of Hope Corona
Corona, California, United States
Sutter Davis Hospital
Davis, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
University Oncology Associates
Fresno, California, United States
Kaiser Permanente
Fresno, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
Mather Veteran Affairs Medical Center
Mather, California, United States
Mercy UC Davis Cancer Center
Merced, California, United States
Memorial Medical Center
Modesto, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Keck Medical Center of USC Pasadena
Pasadena, California, United States
PCR Oncology
Pismo Beach, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter General Hospital
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente - Sacramento
Sacramento, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Stockton
Stockton, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States
Northbay Cancer Center
Vacaville, California, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
The Medical Center of Aurora
Aurora, Colorado, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Colorado Cancer Research Program NCORP
Denver, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Southwest Oncology PC
Durango, Colorado, United States
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Mountain Blue Cancer Care Center
Golden, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
Littleton Adventist Hospital
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Parker Adventist Hospital
Parker, Colorado, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States
Greenwich Hospital
Greenwich, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Regional Hematology and Oncology PA
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Nanticoke Memorial Hospital
Seaford, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center -Washington DC
Washington D.C., District of Columbia, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, United States
Florida Hospital Orlando
Orlando, Florida, United States
UF Cancer Center at Orlando Health
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
John B Amos Cancer Center
Columbus, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Hawaii Oncology Inc-Pali Momi
‘Aiea, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Kootenai Cancer Clinic
Sandpoint, Idaho, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Mount Sinai Hospital Medical Center
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Weiss Memorial Hospital
Chicago, Illinois, United States
Presence Saint Joseph Hospital-Chicago
Chicago, Illinois, United States
Cancer Care Center of Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Heartland Cancer Research NCORP
Decatur, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Hines Veterans Administration Hospital
Hines, Illinois, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States
Presence Saint Mary's Hospital
Kankakee, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Trinity Medical Center
Moline, Illinois, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States
Community Cancer Center Foundation
Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
West Suburban Medical Center
River Forest, Illinois, United States
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, United States
IU Health Bloomington
Bloomington, Indiana, United States
Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Porter Memorial Hospital
Valparaiso, Indiana, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, United States
Genesis Medical Center - East Campus
Davenport, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Iowa City VA Healthcare System
Iowa City, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Saint Catherine Hospital
Garden City, Kansas, United States
Heartland Cancer Center
Great Bend, Kansas, United States
Saint Rose Ambulatory and Surgery Center
Great Bend, Kansas, United States
Hays Medical Center
Hays, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
University of Kansas Cancer Center-West
Kansas City, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Olathe Medical Center
Olathe, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, United States
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States
Topeka VA Hospital
Topeka, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Hematology/Oncology Clinic LLP
Baton Rouge, Louisiana, United States
Ochsner Health Center-Summa
Baton Rouge, Louisiana, United States
Ochsner Medical Center Kenner
Kenner, Louisiana, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Penobscot Bay Medical Center
Rockport, Maine, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Montgomery General Hospital-Olney
Olney, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Steward Saint Elizabeth's Medical Center
Brighton, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Dana Farber Community Cancer Care-Quincy
Quincy, Massachusetts, United States
Hickman Cancer Center
Adrian, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, United States
IHA Hematology Oncology Consultants-Canton
Canton, Michigan, United States
Saint Joseph Mercy Canton Health Center
Canton, Michigan, United States
IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Botsford General Hospital
Farmington, Michigan, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Lakeland Community Hospital
Niles, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Lake Huron Medical Center
Port Huron, Michigan, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
William Beaumont Hospital - Troy
Troy, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Minneapolis Veterans Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Siteman Cancer Center - Saint Peters
City of Saint Peters, Missouri, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Barnes-Jewish West County Hospital
Creve Coeur, Missouri, United States
Mercy Hospital-Joplin
Joplin, Missouri, United States
Truman Medical Center
Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States
The University of Kansas Cancer Center-South
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
The University of Kansas Cancer Center-North
Kansas City, Missouri, United States
The University of Kansas Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Montana Cancer Consortium NCORP
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
CHI Health Saint Francis
Grand Island, Nebraska, United States
CHI Health Good Samaritan
Kearney, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, United States
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, United States
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Sparta Cancer Treatment Center
Sparta, New Jersey, United States
Lovelace Medical Center-Downtown
Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Hematology Oncology Associates
Albuquerque, New Mexico, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, United States
Christus Saint Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus
Brooklyn, New York, United States
Veterans Affairs Western New York Health Care System-Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Orange Regional Medical Center
Middletown, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Columbia University/Herbert Irving Cancer Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
University of Rochester
Rochester, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Dickstein Cancer Treatment Center
White Plains, New York, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Carolinas HealthCare System NorthEast
Concord, North Carolina, United States
Hendersonville Hematology and Oncology at Pardee
Hendersonville, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Park Ridge Hospital Breast Health Center
Hendersonville, North Carolina, United States
Kinston Medical Specialists PA
Kinston, North Carolina, United States
Carolinas HealthCare System Union
Monroe, North Carolina, United States
Carolinas HealthCare System Cleveland
Shelby, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Roger Maris Cancer Center
Fargo, North Dakota, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
Summa Barberton Hospital
Barberton, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Health Center
Dayton, Ohio, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, United States
Veteran Affairs Medical Center
Dayton, Ohio, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States
Armes Family Cancer Center
Findlay, Ohio, United States
Orion Cancer Care
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Saint Rita's Medical Center
Lima, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
Springfield Regional Medical Center
Springfield, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Wright-Patterson Medical Center
Wpafb, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Portland Veterans Administration Medical Center
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Hematology and Oncology Associates of North East Pennsylvania
Scranton, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Roper Hospital
Charleston, South Carolina, United States
Charleston Hematology Oncology Associates-Roper
Charleston, South Carolina, United States
Charleston Hematology Oncology Associates PA-St. Francis
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Saint Francis Cancer Center
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
Lyndon Baines Johnson General Hospital
Houston, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Michael E DeBakey VA Medical Center
Houston, Texas, United States
MD Anderson Regional Care Center-Katy
Houston, Texas, United States
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, United States
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, United States
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Lynchburg Hematology-Oncology Clinic
Lynchburg, Virginia, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
VCU Community Memorial Health Center
South Hill, Virginia, United States
Shenandoah Oncology Associates PC
Winchester, Virginia, United States
MultiCare Auburn Medical Center
Auburn, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Highline Medical Center-Main Campus
Burien, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington, United States
Skagit Valley Hospital
Mount Vernon, Washington, United States
Jefferson Healthcare
Port Townsend, Washington, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States
Minor and James Medical PLLC
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Group Health Cooperative-Seattle
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, United States
Rockwood Clinic
Spokane, Washington, United States
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Northwest NCI Community Oncology Research Program
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
West Virginia University Charleston
Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, United States
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States
Saint Mary's Hospital
Rhinelander, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Diagnostic and Treatment Center
Weston, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Billings Clinic-Cody
Cody, Wyoming, United States
Countries
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References
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Gebrael G, Jo Y, Swami U, Plets M, Hage Chehade C, Narang A, Gupta S, Myint ZW, Sayegh N, Tangen CM, Hussain M, Dorff T, Lara PN Jr, Lerner SP, Thompson I, Agarwal N. Bone Pain and Survival Among Patients With Metastatic, Hormone-Sensitive Prostate Cancer: A Secondary Analysis of the SWOG-1216 Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419966. doi: 10.1001/jamanetworkopen.2024.19966.
Lara PN Jr, Mayerson E, Gertz E, Tangen C, Goldkorn A, van Loan M, Hussain M, Gupta S, Zhang J, Parikh M, Twardowski P, Quinn DI, LeBlanc M, Thompson I, Agarwal N. Markers of bone metabolism and overall survival in men with bone-metastatic hormone sensitive prostate cancer (HSPC): A subset analysis of SWOG S1216, a phase III trial of androgen deprivation with or without orteronel. Prostate Cancer Prostatic Dis. 2024 Sep;27(3):566-570. doi: 10.1038/s41391-024-00813-3. Epub 2024 Feb 29.
Sayegh N, Swami U, Jo Y, Gebrael G, Haaland B, Gupta S, Plets M, Hussain MHA, Quinn DI, Lara PN Jr, Thompson IM Jr, Agarwal N. Race and Treatment Outcomes in Patients With Metastatic Castration-Sensitive Prostate Cancer: A Secondary Analysis of the SWOG 1216 Phase 3 Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2326546. doi: 10.1001/jamanetworkopen.2023.26546.
Agarwal N, Tangen CM, Hussain MHA, Gupta S, Plets M, Lara PN, Harzstark AL, Twardowski PW, Paller CJ, Zylla D, Zibelman MR, Levine E, Roth BJ, Goldkorn A, Vaena DA, Kohli M, Crispino T, Vogelzang NJ, Thompson IM Jr, Quinn DI. Orteronel for Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Randomized, Open-Label Phase III Trial (SWOG-1216). J Clin Oncol. 2022 Oct 1;40(28):3301-3309. doi: 10.1200/JCO.21.02517. Epub 2022 Apr 21.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Study Documents
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Document Type: Individual Participant Data Set
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Related Info
Other Identifiers
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SWOG-S1216
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NCI-2012-02876
Identifier Type: OTHER
Identifier Source: secondary_id
S1216
Identifier Type: -
Identifier Source: org_study_id