A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
ARMOR3-SV
ARMOR3-SV: A Phase 3, Randomized, Open Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC)
1 other identifier
interventional
953
8 countries
117
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Jun 2015
Shorter than P25 for phase_3 prostate-cancer
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMarch 15, 2023
September 1, 2017
1.1 years
March 19, 2015
March 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Radiographic Progression-free survival
≥ 8 months
Secondary Outcomes (2)
Overall Survival
≥ 8 months
Time to Initiation of Cytotoxic Chemotherapy
≥ 8 months
Other Outcomes (6)
Skeletal-related Events
≥ 8 months
Safety measured by clinical safety laboratories and adverse events
≥ 8 months
Prostate Specific Antigen (PSA) Response ≥ 50%
≥ 8 months
- +3 more other outcomes
Study Arms (2)
Galeterone
EXPERIMENTALEnzalutamide
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Progressive metastatic (M1) disease on androgen deprivation therapy
- Detectable AR-V7 from circulating tumors (CTCs)
- ECOG performance status 0 or 1
You may not qualify if:
- Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
- Prior treatment with chemotherapy for CRPC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (117)
Pinnacle Oncology Hematology
Scottsdale, Arizona, 85258, United States
University Of Arizona Cancer Center
Tucson, Arizona, 85724, United States
City of Hope
Duarte, California, 91010, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Prostate Oncology Specialists, Inc.
Marina del Rey, California, 90292, United States
UC Davis Cancer Center
Sacramento, California, 95817, United States
San Bernardino Urological Associates
San Bernardino, California, 92404, United States
Urology Speciality Group
Torrance, California, 90505, United States
University of Colorado Cancer Center Anschultz Cancer Pavilion
Aurora, Colorado, 80045, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Boca Raton Community Hospital, Inc.
Boca Raton, Florida, 33486, United States
University of Florida Health Cancer Center
Orlando, Florida, 32806, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
First Urology
Jeffersonville, Indiana, 47130, United States
Tulane Medical Center
New Orleans, Louisiana, 70115, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
University of Maryland Greenenbaum Cancer Center
Baltimore, Maryland, 21201, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21205, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20307, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Urology Cancer Center and GU Research Network
Omaha, Nebraska, 68130, United States
Coastal Urology Associates
Brick, New Jersey, 08724, United States
Brooklyn Urology Research Group
Brooklyn, New York, 11215, United States
Advanced Urology Centers of New York
Plainview, New York, 11803, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601, United States
Associated Medical Professionals of NY
Syracuse, New York, 13210, United States
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, 27599, United States
Carolina Urology Partners, PLLC
Charlotte, North Carolina, 28277, United States
Carolina Urology Partners
Concord, North Carolina, 28025, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Clinical Research Solutions
Middleburg Heights, Ohio, 44130, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
Lancaster Urology
Lancaster, Pennsylvania, 17604, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology Associates Clinical Research
Nashville, Tennessee, 37209, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Texas Oncology/Baylor University Medical Center
Dallas, Texas, 75246, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Virginia Urology
Richmond, Virginia, 23235, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
The University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
St. George Private Hospital, Oncology Day Care Centre
Kogarah, New South Wales, 2217, Australia
Ashford Cancer Centre/Adelaide Cancer Centre Research
Kurralta Park, New South Wales, 5037, Australia
North Coast Cancer Institute
Port Macquarie, New South Wales, 2444, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Macquarie University
Sydney, New South Wales, 2109, Australia
Peninsula Specialist Centre
Kippa-Ring, Queensland, 4102, Australia
ICON Cancer Care
Southport, Queensland, 4215, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Ashford Cancer Centre/Adelaide Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
East Bentleigh, Victoria, 3165, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002, Australia
Cabrini Hospital
Malvern, Victoria, 3144, Australia
Jules Bordet Institute Clinique d'Oncologie Medicale
Brussels, B-1000, Belgium
Universitair Ziekenhuis Gent
Ghent, B-9000, Belgium
Jessa Ziekenhuis
Hasselt, B-3500, Belgium
CHU Sart Tilman
Liège, 4000, Belgium
British Columbia Cancer
Kelowna, British Columbia, V1Y 5L3, Canada
British Columbia Cancer
Vancouver, British Columbia, V5Z 4E6, Canada
London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier De I'Universite de Montreal
Montreal, Quebec, H2L 4M1, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 3S1, Canada
Centre Paul Papin
Angers, 49055, France
Institut Sainte Catherine
Avignon, 84918, France
Institut Bergonié
Bordeaux, 33076, France
Centre François Baclesse
Caen, 14076, France
Service de Médecine Interne Onco-Hématologie
La Roche-sur-Yon, 85925, France
Clinique Victor Hugo Centre Jean Bernard
Le Mans, 72000, France
Centre Léon Bérard
Lyon, 69008, France
Hôpital Edouard Herriot
Lyon, Cedex 03, France
Centre Antoine Lacassagne
Nice, 06189, France
Centre René Gauducheau
Saint-Herblain, 44805, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805, France
Institut de Cancerlogie de la Loire
Saint-Priest-en-Jarez, 42271, France
Institut Gustave-Roussy
Villejuif, 94805, France
Centro Oncologico c/o Presidio Ospedaliero San Donato - Arezzo
Arezzo, 52100, Italy
Unità Operativa di Oncologia Ospedale Civile degli Infe
Faenza (RA), 48018, Italy
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
Meldola (FC), 47014, Italy
AOU "S. Luigi", SCDU Oncologia Medica
Orbassano (Torino), 10043, Italy
Az. Ospedaliera San Camillo-Forlanini
Roma, 00152, Italy
University of Turin
Torino, 10126, Italy
Santa Chiara Hospital
Trento, 38122, Italy
Hospital Clínic i Provincial de Barcelona-Oncology
Barcelona, 08036, Spain
Instituto Catalan de Oncologia (Hospital Durans i Reynals)
Barcelona, 08908, Spain
Hospital General Universitario de Elche
Elche, 3203, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28009, Spain
Spanish National Cancer Research Centre
Madrid, 28050, Spain
Fundación Althaia Manresa
Manresa, 08243, Spain
Unidad Cnio Ibima de Investigacion en Prostata
Málaga, Spain
Hospital Son Espases - Oncología
Palma de Mallorca, 07010, Spain
Hospital Clinico Universitario de Navarra
Pamplona, 31008, Spain
Consorci Hospitalari de Parc Taulí
Sabadell, 08208, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
IVO-Oncología Médica
Valencia, 46009, Spain
CR-UK Institute for Cancer Studies
Birmingham, England, B15 2PR, United Kingdom
Sussex Cancer Centre
Brighton, England, BN2 5BE, United Kingdom
University College of London Hospitals
London, England, NWI 2PG, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
London, England, SE1 9RT, United Kingdom
Southampton General Hospital
Southampton, England, SO16 6YD, United Kingdom
University of Surrey Post Graduate Medical Hospital
Surrey, England, GU2 7WG, United Kingdom
Royal Marsden Hospital
Surrey, England, SM2 5PT, United Kingdom
The Royal Cornwall Hospital
Truro, England, TR1 3LJ, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN, United Kingdom
Velindre Hospital
Cardiff, Wales, CF14 2TL, United Kingdom
Related Publications (1)
Aragon-Ching JB. The promising role of poly(ADP-ribose) polymerase inhibitors in prostate cancer. Asian J Androl. 2016 Jul-Aug;18(4):592-3. doi: 10.4103/1008-682X.172821.
PMID: 26908063DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2015
First Posted
May 8, 2015
Study Start
June 1, 2015
Primary Completion
July 1, 2016
Study Completion
November 1, 2016
Last Updated
March 15, 2023
Record last verified: 2017-09