An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Study Acronym: PSMAddition
Study Information
Alliance Study ID: AFT-53
NCT Study ID (ClinicalTrials.gov): NCT04720157
Alliance Committee: Genitourinary Cancer
Disease or Cancer Type: Prostate Cancer
Alliance Study Chair: Mike Morris, MD; Scott Tagawa, MD
Status: ACTIVE_NOT_RECRUITING
Study Description
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care (SOC), versus Standard of Care alone, in adult male patients with Metastatic hormone sensitive prostate cancer (mHSPC). In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study. As of 31-Jan-2024, 1144 participants were enrolled in 20 countries.
Related Publications
For publications related to this and other clinical trials, visit the Alliance Publications Application.
Locations (167)
Mayo Clinic – Arizona Mayo Clinic Hospital
Scottsdale, Arizona 85259
United States
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United States
University of California San Diego – Moores Cancer Center
La Jolla, California 92093-0658
United States
VA Greater LA Healthcare System
Los Angeles, California 90073
United States
University of California LA
Los Angeles, California 90095
United States
St. Joseph Hospital
Orange, California 92686
United States
Univ Cali Irvine ALS Neuromuscular
Orange, California 92868
United States
VA Palo Alto Health Care System
Palo Alto, California 94304-1207
United States
Stanford University Medical Center
Palo Alto, California 94304
United States
Sansum Clinic
Santa Barbara, California 93105
United States
Providence Saint Johns Health Ctr
Santa Monica, California 90404
United States
Univ Of Color Anschutz Med Center
Aurora, Colorado 80045
United States
Rocky Mountain Cancer Centers
Denver, Colorado 80218
United States
Hartford Hospital
Hartford, Connecticut 06102
United States
Georgetown University-Lombardi Cancer Center
Washington D.C., District of Columbia 20007
United States
VA Medical Center
Washington D.C., District of Columbia 20422
United States
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United States
Cancer Specialists of North Florida
Jacksonville, Florida 32256
United States
University Of Miami
Miami, Florida 33136
United States
Baptist Health South
Miami, Florida 33173
United States
Florida Cancer Affiliates
Panama City, Florida 32405
United States
University Cancer and Blood Center LLC
Athens, Georgia 30607
United States
The Queens Medical Centre
Honolulu, Hawaii 96813
United States
Northwestern University
Chicago, Illinois 60611
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
University of Chicago
Chicago, Illinois 60637
United States
Hines VA Hospital
Hines, Illinois 60141
United States
Parkview Research Center
Fort Wayne, Indiana 46845
United States
Indiana University
Indianapolis, Indiana 46202
United States
Tulane Cancer Center
New Orleans, Louisiana 70112
United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
Sidney Kimmel CCC At JH
Baltimore, Maryland 21231
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States
Uni Of Michigan Health System
Ann Arbor, Michigan 48109
United States
Corewell Health William Beaum Hosp
Royal Oak, Michigan 48073-6769
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
University of Mississippi Med Ctr
Jackson, Mississippi 39216
United States
St Louis University
St Louis, Missouri 63104
United States
VA St Louis Health Care System
St Louis, Missouri 63106
United States
Wash U School of Medicine
St Louis, Missouri 63110
United States
Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Urology Cancer Center PC
Omaha, Nebraska 68130
United States
University of New Mexico
Albuquerque, New Mexico 87131 0001
United States
Weill Cornell Medical College
New York, New York 10021
United States
Memorial Sloan Kettering Cancer Ctr
New York, New York 10065
United States
Univ Of Rochester Cancer Ctr
Rochester, New York 14642
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Levine Cancer Institute
Charlotte, North Carolina 28203
United States
Duke Univ Medical Center
Durham, North Carolina 27710
United States
Duke Raleigh Hospital
Raleigh, North Carolina 27609
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43221
United States
Oregon Health Sciences University
Portland, Oregon 97239
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania 19107
United States
Univ of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania 15232
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Texas Oncology
Amarillo, Texas 79124
United States
Dallas VA Medical Center
Dallas, Texas 75216
United States
Univ of Texas Southwest Med Center
Dallas, Texas 75390-9034
United States
MD Anderson
Houston, Texas 77030
United States
UT Health Science Center
Houston, Texas 77030
United States
UT Health San Antonio Mays Cancer Center
San Antonio, Texas 78229
United States
University of Virginia Medical Center
Charlottesville, Virginia 22908
United States
Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Onco Hemato Asso of SW Virginia
Roanoke, Virginia 24014
United States
Swedish Medical Center
Seattle, Washington 98122-4379
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Novartis Investigative Site
Innsbruck, Tyrol 6020
Austria
Novartis Investigative Site
Linz, 4020
Austria
Novartis Investigative Site
Vienna, 1090
Austria
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Brussels, 1200
Belgium
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Ghent, 9000
Belgium
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Vancouver, British Columbia V5Z 1M9
Canada
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Hamilton, Ontario L8V 5C2
Canada
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Toronto, Ontario M4N 3M5
Canada
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Montreal, Quebec H2W 1T8
Canada
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Montreal, Quebec H3T 1E2
Canada
Novartis Investigative Site
Montreal, Quebec H4A 3J1
Canada
Novartis Investigative Site
Québec, Quebec G1R 2J6
Canada
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Sherbrooke, Quebec J1H 5N4
Canada
Novartis Investigative Site
Nanjing, Jiangsu 210006
China
Novartis Investigative Site
Nanjing, Jiangsu 210029
China
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Xian, Shanxi 710032
China
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Chengdu, Sichuan 610041
China
Novartis Investigative Site
Beijing, 100036
China
Novartis Investigative Site
Guangzhou, 510060
China
Novartis Investigative Site
Shanghai, 200025
China
Novartis Investigative Site
Shanghai, 200032
China
Novartis Investigative Site
Shanghai, 200080
China
Novartis Investigative Site
Tianjin, 300300
China
Novartis Investigative Site
Olomouc, 779 00
Czechia
Novartis Investigative Site
Prague, 150 06
Czechia
Novartis Investigative Site
Copenhagen, DK-2100
Denmark
Novartis Investigative Site
Bordeaux, 33075
France
Novartis Investigative Site
Clermont-Ferrand, 63011
France
Novartis Investigative Site
Lyon, 69373
France
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Montpellier, 34298
France
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Nantes, 44093
France
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Paris, 75015
France
Novartis Investigative Site
Paris, 75018
France
Novartis Investigative Site
Strasbourg, 67000
France
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Vandœuvre-lès-Nancy, 54511
France
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Villejuif, 94800
France
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Würzburg, Bavaria 97080
Germany
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Cologne, North Rhine-Westphalia 50937
Germany
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Essen, 45147
Germany
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München, 80377
Germany
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Münster, 48149
Germany
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Rostock, 18057
Germany
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Nagoya, Aichi-ken 4668560
Japan
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Sapporo, Hokkaido 060-8648
Japan
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Kobe, Hyōgo 6500047
Japan
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Yokohama, Kanagawa 236-0004
Japan
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Kumamoto, Kumamoto 860-8556
Japan
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Suita, Osaka 565-0871
Japan
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Kitaadachi-gun, Saitama 3620806
Japan
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Bunkyo Ku, Tokyo 1138431
Japan
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Chuo Ku, Tokyo 1040045
Japan
Novartis Investigative Site
Chiba, 260-8717
Japan
Novartis Investigative Site
Fukuoka, 811-0213
Japan
Novartis Investigative Site
Fukuoka, 812-0033
Japan
Novartis Investigative Site
Fukuoka, 8128582
Japan
Novartis Investigative Site
Fukushima, 9601295
Japan
Novartis Investigative Site
Kyoto, 6068507
Japan
Novartis Investigative Site
Okayama, 7008558
Japan
Novartis Investigative Site
Yamagata, 990-9585
Japan
Novartis Investigative Site
Nijmegen, Gelderland 6500HB
Netherlands
Novartis Investigative Site
Maastricht, Limburg 6229 HX
Netherlands
Novartis Investigative Site
Delft, South Holland 2625 AD
Netherlands
Novartis Investigative Site
Utrecht, 3584 CX
Netherlands
Novartis Investigative Site
Gliwice, Silesian Voivodeship 44-101
Poland
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Krakow, 30-688
Poland
Novartis Investigative Site
Warsaw, 02-781
Poland
Novartis Investigative Site
Singapore, 119228
Singapore
Novartis Investigative Site
Singapore, 168583
Singapore
Novartis Investigative Site
Seoul, 03080
South Korea
Novartis Investigative Site
Seoul, 03722
South Korea
Novartis Investigative Site
Seoul, 05505
South Korea
Novartis Investigative Site
L’Hospitalet de Llobregat, Barcelona 08907
Spain
Novartis Investigative Site
Sabadell, Barcelona 08208
Spain
Novartis Investigative Site
Majadahonda, Madrid 28222
Spain
Novartis Investigative Site
El Palmar, Murcia 30120
Spain
Novartis Investigative Site
Barcelona, 08035
Spain
Novartis Investigative Site
Barcelona, 08036
Spain
Novartis Investigative Site
Madrid, 28034
Spain
Novartis Investigative Site
Madrid, 28040
Spain
Novartis Investigative Site
Madrid, 28041
Spain
Novartis Investigative Site
Madrid, 28046
Spain
Novartis Investigative Site
Valencia, 46026
Spain
Novartis Investigative Site
Gothenburg, 413 45
Sweden
Novartis Investigative Site
Lund, 221 85
Sweden
Novartis Investigative Site
Stockholm, 17176
Sweden
Novartis Investigative Site
Bern, 3010
Switzerland
Novartis Investigative Site
Lausanne, 1011
Switzerland
Novartis Investigative Site
Taipei, 10002
Taiwan
Novartis Investigative Site
Taoyuan, 33305
Taiwan
Novartis Investigative Site
Sutton, Surrey SM2 5PT
United Kingdom
Novartis Investigative Site
Belfast, BT9 7AB
United Kingdom
Novartis Investigative Site
Cambridge, CB2 0QQ
United Kingdom
Novartis Investigative Site
Glasgow, G12 0YN
United Kingdom
Novartis Investigative Site
London, EC1A 7BE
United Kingdom
Novartis Investigative Site
London, NW1 2BU
United Kingdom
Novartis Investigative Site
London, NW3 2QG
United Kingdom
Novartis Investigative Site
Middlesbrough, TS4 3BW
United Kingdom
Data Sources & Contacts
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