A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
- Registration Number
- NCT02438007
- Lead Sponsor
- LTN PHARMACEUTICALS, INC.
- Brief Summary
The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 953
- Progressive metastatic (M1) disease on androgen deprivation therapy
- Detectable AR-V7 from circulating tumors (CTCs)
- ECOG performance status 0 or 1
- Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
- Prior treatment with chemotherapy for CRPC
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enzalutamide Enzalutamide - Galeterone Galeterone -
- Primary Outcome Measures
Name Time Method Radiographic Progression-free survival ≥ 8 months
- Secondary Outcome Measures
Name Time Method Time to Initiation of Cytotoxic Chemotherapy ≥ 8 months Overall Survival ≥ 8 months
Trial Locations
- Locations (115)
Hospital Clínic i Provincial de Barcelona-Oncology
🇪🇸Barcelona, Spain
Unidad Cnio Ibima de Investigacion en Prostata
🇪🇸Malaga, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Son Espases - Oncología
🇪🇸Palma de Mallorca, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Centro Oncologico c/o Presidio Ospedaliero San Donato - Arezzo
🇮🇹Arezzo, Italy
Spanish National Cancer Research Centre
🇪🇸Madrid, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Fundación Althaia Manresa
🇪🇸Manresa, Spain
Hospital Clinico Universitario de Navarra
🇪🇸Pamplona, Spain
Consorci Hospitalari de Parc Taulí
🇪🇸Sabadell, Spain
Instituto Catalan de Oncologia (Hospital Durans i Reynals)
🇪🇸Barcelona, Spain
IVO-Oncología Médica
🇪🇸Valencia, Spain
Sunnybrook Research Institute
🇨🇦Toronto, Ontario, Canada
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Boca Raton Community Hospital, Inc.
🇺🇸Boca Raton, Florida, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Texas Oncology/Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Guy's and St. Thomas' NHS Foundation Trust
🇬🇧London, England, United Kingdom
Centre Léon Bérard
🇫🇷Lyon, France
Pinnacle Oncology Hematology
🇺🇸Scottsdale, Arizona, United States
University Of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
City of Hope
🇺🇸Duarte, California, United States
UCLA Jonsson Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Prostate Oncology Specialists, Inc.
🇺🇸Marina Del Rey, California, United States
San Bernardino Urological Associates
🇺🇸San Bernardino, California, United States
UC Davis Cancer Center
🇺🇸Sacramento, California, United States
Urology Speciality Group
🇺🇸Torrance, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
University of Florida Health Cancer Center
🇺🇸Orlando, Florida, United States
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
First Urology
🇺🇸Jeffersonville, Indiana, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
University of Maryland Greenenbaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Coastal Urology Associates
🇺🇸Brick, New Jersey, United States
Brooklyn Urology Research Group
🇺🇸Brooklyn, New York, United States
Advanced Urology Centers of New York
🇺🇸Plainview, New York, United States
Associated Medical Professionals of NY
🇺🇸Syracuse, New York, United States
Premier Medical Group of the Hudson Valley
🇺🇸Poughkeepsie, New York, United States
University of North Carolina Lineberger Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Carolina Urology Partners, PLLC
🇺🇸Charlotte, North Carolina, United States
Carolina Urology Partners
🇺🇸Concord, North Carolina, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Clinical Research Solutions
🇺🇸Middleburg Heights, Ohio, United States
Oregon Urology Institute
🇺🇸Springfield, Oregon, United States
Lancaster Urology
🇺🇸Lancaster, Pennsylvania, United States
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
The University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Ashford Cancer Centre/Adelaide Cancer Centre Research
🇦🇺Kurralta Park, South Australia, Australia
St. George Private Hospital, Oncology Day Care Centre
🇦🇺Kogarah, New South Wales, Australia
Peninsula Specialist Centre
🇦🇺Kippa-Ring, Queensland, Australia
North Coast Cancer Institute
🇦🇺Port Macquarie, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Macquarie University
🇦🇺Sydney, New South Wales, Australia
ICON Cancer Care
🇦🇺Southport, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Monash Medical Centre
🇦🇺East Bentleigh, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Cabrini Hospital
🇦🇺Malvern, Victoria, Australia
Jules Bordet Institute Clinique d'Oncologie Medicale
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
CHU Sart Tilman
🇧🇪Liège, Belgium
London Health Sciences Centre
🇨🇦London, Ontario, Canada
British Columbia Cancer
🇨🇦Vancouver, British Columbia, Canada
Centre Hospitalier De I'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Centre Paul Papin
🇫🇷Angers Cedex 9, France
Institut Sainte Catherine
🇫🇷Avignon, France
Institut Bergonié
🇫🇷Bordeaux, France
Centre François Baclesse
🇫🇷Caen Cedex, France
Centre Antoine Lacassagne
🇫🇷Nice Cedex 2, France
Institut de Cancérologie de l'Ouest
🇫🇷Saint Herblain, France
Institut de Cancerlogie de la Loire
🇫🇷Saint Priest en Jarez, France
Centre René Gauducheau
🇫🇷Saint-Herblain, France
Institut Gustave-Roussy
🇫🇷Villejuif, France
Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
Urology Associates Clinical Research
🇺🇸Nashville, Tennessee, United States
Urology San Antonio
🇺🇸San Antonio, Texas, United States
Unità Operativa di Oncologia Ospedale Civile degli Infe
🇮🇹Faenza (RA), Italy
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
🇮🇹Meldola (FC), Italy
AOU "S. Luigi", SCDU Oncologia Medica
🇮🇹Orbassano (Torino), Italy
University of Turin
🇮🇹Torino, Italy
Santa Chiara Hospital
🇮🇹Trento, Italy
Az. Ospedaliera San Camillo-Forlanini
🇮🇹Roma, Italy
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
CR-UK Institute for Cancer Studies
🇬🇧Birmingham, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
University of Surrey Post Graduate Medical Hospital
🇬🇧Surrey, England, United Kingdom
The Royal Cornwall Hospital
🇬🇧Truro, England, United Kingdom
University College of London Hospitals
🇬🇧London, England, United Kingdom
The Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Service de Médecine Interne Onco-Hématologie
🇫🇷La Roche Sur Yon Cedex 9, France
Clinique Victor Hugo Centre Jean Bernard
🇫🇷Le Mans, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
University of Colorado Cancer Center Anschultz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Urology Cancer Center and GU Research Network
🇺🇸Omaha, Nebraska, United States
Royal Marsden Hospital
🇬🇧Surrey, England, United Kingdom
Sussex Cancer Centre
🇬🇧Brighton, England, United Kingdom