Clinical trial NCT02438007: A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: LTN PHARMACEUTICALS, INC.
Sponsor class: INDUSTRY
First posted: 2015-05-08
Enrollment: 953
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* Progressive metastatic (M1) disease on androgen deprivation therapy
* Detectable AR-V7 from circulating tumors (CTCs)
* ECOG performance status 0 or 1

Exclusion Criteria:

* Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
* Prior treatment with chemotherapy for CRPC

Primary outcomes:
measure: Radiographic Progression-free survival
timeFrame: ≥ 8 months
Secondary outcomes:
measure: Overall Survival
timeFrame: ≥ 8 months
measure: Time to Initiation of Cytotoxic Chemotherapy
timeFrame: ≥ 8 months
Other outcomes:
measure: Skeletal-related Events
timeFrame: ≥ 8 months
measure: Safety measured by clinical safety laboratories and adverse events
timeFrame: ≥ 8 months
measure: Prostate Specific Antigen (PSA) Response ≥ 50%
timeFrame: ≥ 8 months
measure: Time to PSA progression
timeFrame: ≥ 8 months
measure: Time to ECOG deterioration
timeFrame: ≥ 8 months
measure: Best Overall Response by RECIST 1.1
timeFrame: ≥ 8 months
Locations:
city: Scottsdale
country: United States
facility: Pinnacle Oncology Hematology
state: Arizona
city: Tucson
country: United States
facility: University Of Arizona Cancer Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center
state: California
city: Marina Del Rey
country: United States
facility: Prostate Oncology Specialists, Inc.
state: California
city: Sacramento
country: United States
facility: UC Davis Cancer Center
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates
state: California
city: Torrance
country: United States
facility: Urology Speciality Group
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center Anschultz Cancer Pavilion
state: Colorado
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Boca Raton
country: United States
facility: Boca Raton Community Hospital, Inc.
state: Florida
city: Orlando
country: United States
facility: University of Florida Health Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Jeffersonville
country: United States
facility: First Urology
state: Indiana
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Greenenbaum Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Center
state: Michigan
city: Omaha
country: United States
facility: Urology Cancer Center and GU Research Network
state: Nebraska
city: Brick
country: United States
facility: Coastal Urology Associates
state: New Jersey
city: Brooklyn
country: United States
facility: Brooklyn Urology Research Group
state: New York
city: Plainview
country: United States
facility: Advanced Urology Centers of New York
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Lineberger Cancer Center
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Urology Partners, PLLC
state: North Carolina
city: Concord
country: United States
facility: Carolina Urology Partners
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions
state: Ohio
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Lancaster
country: United States
facility: Lancaster Urology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Centers
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates Clinical Research
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology/Baylor University Medical Center
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Madison
country: United States
facility: The University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
state: Wisconsin
city: Kogarah
country: Australia
facility: St. George Private Hospital, Oncology Day Care Centre
state: New South Wales
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre/Adelaide Cancer Centre Research
state: New South Wales
city: Port Macquarie
country: Australia
facility: North Coast Cancer Institute
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie University
state: New South Wales
city: Kippa-Ring
country: Australia
facility: Peninsula Specialist Centre
state: Queensland
city: Southport
country: Australia
facility: ICON Cancer Care
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre/Adelaide Cancer Centre Research
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: East Bentleigh
country: Australia
facility: Monash Medical Centre
state: Victoria
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Brussels
country: Belgium
facility: Jules Bordet Institute Clinique d'Oncologie Medicale
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Liège
country: Belgium
facility: CHU Sart Tilman
city: Kelowna
country: Canada
facility: British Columbia Cancer
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier De I'Universite de Montreal
state: Quebec
city: Quebec City
country: Canada
facility: Centre Hospitalier Universitaire de Quebec
state: Quebec
city: Angers Cedex 9
country: France
facility: Centre Paul Papin
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen Cedex
country: France
facility: Centre François Baclesse
city: La Roche Sur Yon Cedex 9
country: France
facility: Service de Médecine Interne Onco-Hématologie
city: Le Mans
country: France
facility: Clinique Victor Hugo Centre Jean Bernard
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Nice Cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Saint Priest en Jarez
country: France
facility: Institut de Cancerlogie de la Loire
city: Saint-Herblain
country: France
facility: Centre René Gauducheau
city: Villejuif
country: France
facility: Institut Gustave-Roussy
city: Arezzo
country: Italy
facility: Centro Oncologico c/o Presidio Ospedaliero San Donato - Arezzo
city: Faenza (RA)
country: Italy
facility: Unità Operativa di Oncologia Ospedale Civile degli Infe
city: Meldola (FC)
country: Italy
facility: Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
city: Orbassano (Torino)
country: Italy
facility: AOU "S. Luigi", SCDU Oncologia Medica
city: Roma
country: Italy
facility: Az. Ospedaliera San Camillo-Forlanini
city: Torino
country: Italy
facility: University of Turin
city: Trento
country: Italy
facility: Santa Chiara Hospital
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona-Oncology
city: Barcelona
country: Spain
facility: Instituto Catalan de Oncologia (Hospital Durans i Reynals)
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Spanish National Cancer Research Centre
city: Malaga
country: Spain
facility: Unidad Cnio Ibima de Investigacion en Prostata
city: Manresa
country: Spain
facility: Fundación Althaia Manresa
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases - Oncología
city: Pamplona
country: Spain
facility: Hospital Clinico Universitario de Navarra
city: Sabadell
country: Spain
facility: Consorci Hospitalari de Parc Taulí
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: IVO-Oncología Médica
city: Birmingham
country: United Kingdom
facility: CR-UK Institute for Cancer Studies
state: England
city: Brighton
country: United Kingdom
facility: Sussex Cancer Centre
state: England
city: London
country: United Kingdom
facility: University College of London Hospitals
state: England
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Surrey
country: United Kingdom
facility: University of Surrey Post Graduate Medical Hospital
state: England
city: Surrey
country: United Kingdom
facility: Royal Marsden Hospital
state: England
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital
state: England
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
state: Scotland
city: Cardiff
country: United Kingdom
facility: Velindre Hospital
state: Wales
Study officials:
References:
citation: 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.