1,145
Participants
Start Date
June 9, 2021
Primary Completion Date
January 13, 2025
Study Completion Date
February 11, 2027
177Lu-PSMA-617
administered intravenously once every 6 weeks (1 cycle) for 6 cycles
68Ga-PSMA-11
Intravenous dose of approx. 150 Megabecquerel (MBq) at screening and at time of centrally confirmed rPD
ARDT
Administered orally on a continuous basis as per package insert and guideline
ADT
ADT are administered as per physician order
Novartis Investigative Site, Lausanne
Novartis Investigative Site, Vienna
Novartis Investigative Site, Brussels
Novartis Investigative Site, Bern
Novartis Investigative Site, Linz
Novartis Investigative Site, Innsbruck
Novartis Investigative Site, Ghent
Novartis Investigative Site, Taipei
Weill Cornell Medical College, New York
Memorial Sloan Kettering Cancer Ctr, New York
Montefiore Medical Center, The Bronx
Univ Of Rochester Cancer Ctr, Rochester
Univ of Pittsburgh Cancer Institute, Pittsburgh
Penn State Hershey Medical Center, Hershey
Novartis Investigative Site, Stockholm
Novartis Investigative Site, Rostock
Thomas Jefferson Univ Hosp, Philadelphia
Georgetown University-Lombardi Cancer Center, Washington D.C.
VA Medical Center, Washington D.C.
Sidney Kimmel CCC At JH, Baltimore
University of Virginia Medical Center, Charlottesville
Virginia Oncology Associates, Norfolk
Onco Hemato Asso of SE Virginia, Roanoke
Duke Univ Medical Center, Durham
Novartis Investigative Site, Madrid
Novartis Investigative Site, Madrid
Novartis Investigative Site, Madrid
Novartis Investigative Site, Madrid
Levine Cancer Institute, Charlotte
Novartis Investigative Site, Madrid
Carolina Urologic Research Center, Myrtle Beach
Novartis Investigative Site, El Palmar
University Cancer and Blood Center LLC, Athens
Mayo Clinic Jacksonville, Jacksonville
Cancer Specialists of North Florida, Jacksonville
Florida Cancer Affiliates, Panama City
Novartis Investigative Site, Bordeaux
University Of Miami, Miami
Baptist Health Medical Group, Miami
Novartis Investigative Site, Taoyuan District
Novartis Investigative Site, Montpellier
University of Mississippi Med Ctr, Jackson
The Ohio State University Comprehensive Cancer Center, Columbus
Novartis Investigative Site, Nantes
Cleveland Clinic Foundation, Cleveland
Novartis Investigative Site, Essen
Novartis Investigative Site, Valencia
Indiana University, Indianapolis
Parkview Research Center, Fort Wayne
Uni Of Michigan Health System, Ann Arbor
Novartis Investigative Site, Münster
Novartis Investigative Site, Cologne
Medical College Of Wisconsin, Milwaukee
Novartis Investigative Site, Vandœuvre-lès-Nancy
University of Minnesota, Minneapolis
Mayo Clinic Rochester, Rochester
Mayo Clinic, Rochester
Hines VA Hospital, Hines
Northwestern University, Chicago
Rush University Medical Center, Chicago
University of Chicago, Chicago
Novartis Investigative Site, Clermont-Ferrand
St. Louis University, St Louis
VA St Louis Health Care System, St Louis
Wash U School of Medicine, St Louis
Novartis Investigative Site, Strasbourg
Nebraska Cancer Specialists, Omaha
Urology Cancer Center PC, Omaha
Novartis Investigative Site, Lyon
Tulane Cancer Center, New Orleans
Ochsner Clinic Foundation, New Orleans
Novartis Investigative Site, Paris
Novartis Investigative Site, Paris
Dallas VA Medical Center, Dallas
Texas Oncology, Dallas
MD Anderson, Houston
UT Health Science Center, Houston
UT Health San Antonio Mays Cancer Center, San Antonio
Univ Of Color Anschutz Med Center, Aurora
Rocky Mountain Cancer Centers, Denver
Novartis Investigative Site, München
Mayo Clinic - Arizona Mayo Clinic Hospital, Scottsdale
Mayo Clinic Arizona, Scottsdale
VA Greater LA Healthcare System, Los Angeles
University of California LA, Los Angeles
Providence Saint Johns Health Ctr, Santa Monica
St. Joseph Hospital, Orange
Univ Cali Irvine ALS Neuromuscular, Orange
Sansum Clinic, Santa Barbara
Stanford University Medical Center, Palo Alto
Novartis Investigative Site, Villejuif
The Queens Medical Centre, Honolulu
Novartis Investigative Site, Würzburg
Oregon Health Sciences University, Portland
Novartis Investigative Site, Beijing
Novartis Investigative Site, Singapore
Novartis Investigative Site, Singapore
Novartis Investigative Site, Shanghai
Novartis Investigative Site, Shanghai
Novartis Investigative Site, Shanghai
Novartis Investigative Site, Nanjing
Novartis Investigative Site, Nanjing
Novartis Investigative Site, Tianjin
Novartis Investigative Site, Guangzhou
Novartis Investigative Site, Chengdu
Novartis Investigative Site, Xian
University of California San Diego - Moores Cancer Center, La Jolla
VA Palo Alto Health Care System, Palo Alto
Hartford Hospital, Hartford
Dana Farber Cancer Institute, Boston
Corewell Health William Beaum Hosp, Royal Oak
University of New Mexico, Albuquerque
Univ of Texas Southwest Med Center, Dallas
Swedish Medical Center, Seattle
Novartis Investigative Site, Vancouver
Novartis Investigative Site, Hamilton
Novartis Investigative Site, Toronto
Novartis Investigative Site, Montreal
Novartis Investigative Site, Montreal
Novartis Investigative Site, Montreal
Novartis Investigative Site, Québec
Novartis Investigative Site, Sherbrooke
Novartis Investigative Site, Olomouc
Novartis Investigative Site, Prague
Novartis Investigative Site, Copenhagen
Novartis Investigative Site, Nagoya
Novartis Investigative Site, Fukuoka
Novartis Investigative Site, Fukushima
Novartis Investigative Site, Sapporo
Novartis Investigative Site, Kobe
Novartis Investigative Site, Yokohama
Novartis Investigative Site, Okayama
Novartis Investigative Site, Suita
Novartis Investigative Site, Kitaadachi-gun
Novartis Investigative Site, Bunkyo Ku
Novartis Investigative Site, Chuo Ku
Novartis Investigative Site, Chiba
Novartis Investigative Site, Fukuoka
Novartis Investigative Site, Fukuoka
Novartis Investigative Site, Kumamoto
Novartis Investigative Site, Kyoto
Novartis Investigative Site, Yamagata
Novartis Investigative Site, Nijmegen
Novartis Investigative Site, Maastricht
Novartis Investigative Site, Delft
Novartis Investigative Site, Utrecht
Novartis Investigative Site, Gliwice
Novartis Investigative Site, Krakow
Novartis Investigative Site, Warsaw
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, L'Hospitalet de Llobregat
Novartis Investigative Site, Sabadell
Novartis Investigative Site, Barcelona
Novartis Investigative Site, Barcelona
Novartis Investigative Site, Gothenburg
Novartis Investigative Site, Lund
Novartis Investigative Site, Sutton
Novartis Investigative Site, Belfast
Novartis Investigative Site, Cambridge
Novartis Investigative Site, Glasgow
Novartis Investigative Site, London
Novartis Investigative Site, London
Novartis Investigative Site, London
Novartis Investigative Site, Middlesbrough
Lead Sponsor
Alliance Foundation Trials, LLC.
OTHER
RTOG Foundation, Inc.
OTHER
Novartis Pharmaceuticals
INDUSTRY