Prostate CancerPhase 3ARMOR3-SVNCT02438007
A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
A Phase 3 study testing Galeterone and Enzalutamide in people with Prostate Cancer, run by LTN PHARMACEUTICALS, INC. at 117 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Galeterone and Enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 953 participants
- Where
- 117 sitesin 8 countries
- Study dates
- Jun 2015to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Progressive metastatic (M1) disease on androgen deprivation therapy
- Detectable AR-V7 from circulating tumors (CTCs)
- ECOG performance status 0 or 1
Who cannot join
- Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
- Prior treatment with chemotherapy for CRPC
Trial locations and contacts
117 sites in 8 countries.
117 sites in 8 countries
United States51 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Colorado Cancer Center Anschultz Cancer Pavilion
Aurora, Colorado, 80045
University of Maryland Greenenbaum Cancer Center
Baltimore, Maryland, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21205
Walter Reed National Military Medical Center
Bethesda, Maryland, 20307
Boca Raton Community Hospital, Inc.
Boca Raton, Florida, 33486
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Coastal Urology Associates
Brick, New Jersey, 08724
Brooklyn Urology Research Group
Brooklyn, New York, 11215
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, 27599
Carolina Urology Partners, PLLC
Charlotte, North Carolina, 28277
The Urology Group
Cincinnati, Ohio, 45212
Carolina Urology Partners
Concord, North Carolina, 28025
Urology Clinics of North Texas
Dallas, Texas, 75231
Texas Oncology/Baylor University Medical Center
Dallas, Texas, 75246
The Urology Center of Colorado
Denver, Colorado, 80211
Karmanos Cancer Center
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
First Urology
Jeffersonville, Indiana, 47130
Lancaster Urology
Lancaster, Pennsylvania, 17604
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
The University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792
Prostate Oncology Specialists, Inc.
Marina del Rey, California, 90292
Clinical Research Solutions
Middleburg Heights, Ohio, 44130
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Urology Associates Clinical Research
Nashville, Tennessee, 37209
Yale University School of Medicine
New Haven, Connecticut, 06510
Tulane Medical Center
New Orleans, Louisiana, 70115
Urology Cancer Center and GU Research Network
Omaha, Nebraska, 68130
University of Florida Health Cancer Center
Orlando, Florida, 32806
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232
Advanced Urology Centers of New York
Plainview, New York, 11803
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
Virginia Urology
Richmond, Virginia, 23235
UC Davis Cancer Center
Sacramento, California, 95817
Urology San Antonio
San Antonio, Texas, 78229
San Bernardino Urological Associates
San Bernardino, California, 92404
Pinnacle Oncology Hematology
Scottsdale, Arizona, 85258
Regional Urology, LLC
Shreveport, Louisiana, 71106
Oregon Urology Institute
Springfield, Oregon, 97477
Associated Medical Professionals of NY
Syracuse, New York, 13210
Moffitt Cancer Center
Tampa, Florida, 33612
Urology Speciality Group
Torrance, California, 90505
University Of Arizona Cancer Center
Tucson, Arizona, 85724
Urology of Virginia
Virginia Beach, Virginia, 23462
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Australia13 sites
Box Hill Hospital
Box Hill, Victoria, 3128
Monash Medical Centre
East Bentleigh, Victoria, 3165
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
Peninsula Specialist Centre
Kippa-Ring, Queensland, 4102
St. George Private Hospital, Oncology Day Care Centre
Kogarah, New South Wales, 2217
Ashford Cancer Centre/Adelaide Cancer Centre Research
Kurralta Park, New South Wales, 5037
Ashford Cancer Centre/Adelaide Cancer Centre Research
Kurralta Park, South Australia, 5037
Cabrini Hospital
Malvern, Victoria, 3144
North Coast Cancer Institute
Port Macquarie, New South Wales, 2444
Prince of Wales Hospital
Randwick, New South Wales, 2031
ICON Cancer Care
Southport, Queensland, 4215
Macquarie University
Sydney, New South Wales, 2109
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
France13 sites
Centre Paul Papin
Angers, 49055
Institut Sainte Catherine
Avignon, 84918
Institut Bergonié
Bordeaux, 33076
Centre François Baclesse
Caen, 14076
Service de Médecine Interne Onco-Hématologie
La Roche-sur-Yon, 85925
Clinique Victor Hugo Centre Jean Bernard
Le Mans, 72000
Centre Léon Bérard
Lyon, 69008
Hôpital Edouard Herriot
Lyon, Cedex 03
Centre Antoine Lacassagne
Nice, 06189
Centre René Gauducheau
Saint-Herblain, 44805
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Institut de Cancerlogie de la Loire
Saint-Priest-en-Jarez, 42271
Institut Gustave-Roussy
Villejuif, 94805
Spain12 sites
Hospital Clínic i Provincial de Barcelona-Oncology
Barcelona, 08036
Instituto Catalan de Oncologia (Hospital Durans i Reynals)
Barcelona, 08908
Hospital General Universitario de Elche
Elche, 3203
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Spanish National Cancer Research Centre
Madrid, 28050
Unidad Cnio Ibima de Investigacion en Prostata
Málaga
Fundación Althaia Manresa
Manresa, 08243
Hospital Son Espases - Oncología
Palma de Mallorca, 07010
Hospital Clinico Universitario de Navarra
Pamplona, 31008
Consorci Hospitalari de Parc Taulí
Sabadell, 08208
Hospital Universitario Virgen del Rocio
Seville, 41013
IVO-Oncología Médica
Valencia, 46009
United Kingdom10 sites
CR-UK Institute for Cancer Studies
Birmingham, England, B15 2PR
Sussex Cancer Centre
Brighton, England, BN2 5BE
Velindre Hospital
Cardiff, Wales, CF14 2TL
The Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
University College of London Hospitals
London, England, NWI 2PG
Guy's and St. Thomas' NHS Foundation Trust
London, England, SE1 9RT
Southampton General Hospital
Southampton, England, SO16 6YD
University of Surrey Post Graduate Medical Hospital
Surrey, England, GU2 7WG
Royal Marsden Hospital
Surrey, England, SM2 5PT
The Royal Cornwall Hospital
Truro, England, TR1 3LJ
Canada7 sites
British Columbia Cancer
Kelowna, British Columbia, V1Y 5L3
London Health Sciences Centre
London, Ontario, N6A 4L6
Centre Hospitalier De I'Universite de Montreal
Montreal, Quebec, H2L 4M1
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 3S1
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
British Columbia Cancer
Vancouver, British Columbia, V5Z 4E6
Italy7 sites
Centro Oncologico c/o Presidio Ospedaliero San Donato - Arezzo
Arezzo, 52100
Unità Operativa di Oncologia Ospedale Civile degli Infe
Faenza (RA), 48018
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
Meldola (FC), 47014
AOU "S. Luigi", SCDU Oncologia Medica
Orbassano (Torino), 10043
Az. Ospedaliera San Camillo-Forlanini
Roma, 00152
University of Turin
Torino, 10126
Santa Chiara Hospital
Trento, 38122
Belgium4 sites
Jules Bordet Institute Clinique d'Oncologie Medicale
Brussels, B-1000
Universitair Ziekenhuis Gent
Ghent, B-9000
Jessa Ziekenhuis
Hasselt, B-3500
CHU Sart Tilman
Liège, 4000
About this study
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)
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).
- Conditions
- Prostate Cancer
- Being tested
- Galeterone, Enzalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GaleteroneDrug
Also called TOK-001
2550 mg galeterone tablets once daily PO
EnzalutamideDrug
Also called Xtandi®
160 mg enzalutamide capsules once daily PO
| Study group | Role | What they receive |
|---|---|---|
| Galeterone | Experimental | Not described Receives: Drug: Galeterone |
| Enzalutamide | Active comparator | Not described Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Progression-free survival
Measured: ≥ 8 months
Secondary outcomes (2)
Overall Survival
Measured: ≥ 8 months
Time to Initiation of Cytotoxic Chemotherapy
Measured: ≥ 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 953 participants (actual)
Sponsor and investigators
- Lead sponsor
- LTN PHARMACEUTICALS, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438007
- Sponsor's protocol ID
- ARMOR3-SV
- Acronym
- ARMOR3-SV
- Status last verified
- Sep 2017
- First submitted
- 19 Mar 2015
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26908063
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02438007
- Acronym / sponsor ID
- ARMOR3-SV / ARMOR3-SV
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 953 participants (actual)
- Lead sponsor
- LTN PHARMACEUTICALS, INC.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galeterone | Experimental | Drug: Galeterone |
| Enzalutamide | Active comparator | Drug: Enzalutamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Progressive metastatic (M1) disease on androgen deprivation therapy
- Detectable AR-V7 from circulating tumors (CTCs)
- ECOG performance status 0 or 1
Key exclusion criteria (2 listed)
- Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
- Prior treatment with chemotherapy for CRPC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GaleteroneAlso: TOK-0012550 mg galeterone tablets once daily PO | Drug | Galeterone |
| EnzalutamideAlso: Xtandi®160 mg enzalutamide capsules once daily PO | Drug | Enzalutamide |
Primary outcome
Radiographic Progression-free survival
Time frame: ≥ 8 months
2 secondary outcomes
Overall Survival
Time frame: ≥ 8 months
Time to Initiation of Cytotoxic Chemotherapy
Time frame: ≥ 8 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 26908063Aragon-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
117 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Galeterone and Enzalutamide in people with Prostate Cancer, run by LTN PHARMACEUTICALS, INC. at 117 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 117 sites in United States, Australia, France, Spain, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Progression-free survival (time frame: ≥ 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02438007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.