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

Novartis Investigative Site
Brussels, 1200
Belgium

Novartis Investigative Site
Ghent, 9000
Belgium

Novartis Investigative Site
Vancouver, British Columbia V5Z 1M9
Canada

Novartis Investigative Site
Hamilton, Ontario L8V 5C2
Canada

Novartis Investigative Site
Toronto, Ontario M4N 3M5
Canada

Novartis Investigative Site
Montreal, Quebec H2W 1T8
Canada

Novartis Investigative Site
Montreal, Quebec H3T 1E2
Canada

Novartis Investigative Site
Montreal, Quebec H4A 3J1
Canada

Novartis Investigative Site
Québec, Quebec G1R 2J6
Canada

Novartis Investigative Site
Sherbrooke, Quebec J1H 5N4
Canada

Novartis Investigative Site
Nanjing, Jiangsu 210006
China

Novartis Investigative Site
Nanjing, Jiangsu 210029
China

Novartis Investigative Site
Xian, Shanxi 710032
China

Novartis Investigative Site
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

Novartis Investigative Site
Montpellier, 34298
France

Novartis Investigative Site
Nantes, 44093
France

Novartis Investigative Site
Paris, 75015
France

Novartis Investigative Site
Paris, 75018
France

Novartis Investigative Site
Strasbourg, 67000
France

Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
France

Novartis Investigative Site
Villejuif, 94800
France

Novartis Investigative Site
Würzburg, Bavaria 97080
Germany

Novartis Investigative Site
Cologne, North Rhine-Westphalia 50937
Germany

Novartis Investigative Site
Essen, 45147
Germany

Novartis Investigative Site
München, 80377
Germany

Novartis Investigative Site
Münster, 48149
Germany

Novartis Investigative Site
Rostock, 18057
Germany

Novartis Investigative Site
Nagoya, Aichi-ken 4668560
Japan

Novartis Investigative Site
Sapporo, Hokkaido 060-8648
Japan

Novartis Investigative Site
Kobe, Hyōgo 6500047
Japan

Novartis Investigative Site
Yokohama, Kanagawa 236-0004
Japan

Novartis Investigative Site
Kumamoto, Kumamoto 860-8556
Japan

Novartis Investigative Site
Suita, Osaka 565-0871
Japan

Novartis Investigative Site
Kitaadachi-gun, Saitama 3620806
Japan

Novartis Investigative Site
Bunkyo Ku, Tokyo 1138431
Japan

Novartis Investigative Site
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

Novartis Investigative Site
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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