An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02531516
Recruitment Status : Recruiting
First Posted : August 24, 2015
Last Update Posted : April 6, 2018
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Apalutamide Drug: Bicalutamide Drug: Bicalutamide Placebo Drug: Apalutamide Placebo Drug: GnRH (agonist) Radiation: 74-80 Grays (units of radiation) Phase 3

Detailed Description:
This is a randomized, double-blind, placebo-controlled, multicenter study of apalutamide plus GnRH agonist compared with GnRH agonist among participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT). The study will include a Screening Phase, Treatment Phase, a Posttreatment Phase, and a Long-term Follow-up Phase. Participants will either receive either apalutamide (experimental) or bicalutamide 50 milligram (mg) capsule plus placebo as control group. Safety will be monitored throughout the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy
Actual Study Start Date : November 19, 2015
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : October 6, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Apalutamide
Participants will receive apalutamide (240 mg), by mouth, once daily for overall 30 months, plus bicalutamide placebo, by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
Drug: Apalutamide Drug: Bicalutamide Placebo Drug: GnRH (agonist) Radiation: 74-80 Grays (units of radiation)
Active Comparator: Control group
Participants will receive apalutamide placebo, by mouth, once daily for overall 30 months, plus bicalutamide (50 mg), by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
Drug: Bicalutamide Drug: Apalutamide Placebo Drug: GnRH (agonist) Radiation: 74-80 Grays (units of radiation)

Primary Outcome Measures :
  1. Metastasis-free survival [ Time Frame: 84 Months ]

Secondary Outcome Measures :
  1. Time to Local-regional Recurrence [ Time Frame: 84 Months ]
  2. Time to Castration-resistant Prostate Cancer (CRPC) [ Time Frame: 84 Months ]
  3. Time to Distant Metastasis [ Time Frame: 84 Months ]
  4. Overall Survival (OS) [ Time Frame: 84 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >= 18 years
  • Indicated and planned to receive primary radiation therapy for prostate cancer
  • Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score >=8 and >=cT2c, 2) Gleason score >=7, PSA >=20 nanogram per milliliters (ng/mL), and >=cT2c
  • Charlson index (CCI) <=3
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
  • Adequate organ function: (1) aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (<) 1.5 milligram/deciliter (mg/dL) (<133 micromoles/Liter [mcmol/L]), (3) platelets greater than or equal to (>=)140,000/microLiter (mcL), independent of transfusion and/or growth factors within 3 months prior to randomization, (4) Hemoglobin >= 12.0 gram/deciliter (g/dL) (7.4 millimloes [mmol], independent of transfusion and/or growth factors within 3 months prior to randomization
  • Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
  • Signed, written, informed consent
  • Be able to swallow whole study drug tablets

Exclusion Criteria: -

  • Presence of distant metastasis, (clinical stage M1). Isolated pelvic nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0.
  • Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for >3 months prior to randomization
  • Bilateral orchiectomy
  • History of pelvic radiation
  • Prior systemic (example [e.g.], chemotherapy) or local (e.g. radical prostatectomy, cryotherapy) treatment for prostate cancer
  • History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness <= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
  • Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer
  • Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., sipuleucel-T) for prostate cancer
  • Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study
  • Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) <=4 weeks prior to randomization
  • Use of any investigational agent <=4 weeks prior to randomization
  • Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for non-oral formulations
  • Major surgery <=4 weeks prior to randomization
  • Current or prior treatment with anti-epileptic medications for the treatment of seizures
  • Gastrointestinal conditions affecting absorption
  • Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide or GnRH agonists or any of the components of the formulations
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02531516

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

  Hide Study Locations
United States, Alabama
Urology Centers Of Alabama Completed
Homewood, Alabama, United States, 35209
United States, Arizona
Ironwood Cancer and Research Center Recruiting
Chandler, Arizona, United States, 85224
21st Century Oncology Completed
Scottsdale, Arizona, United States, 85251
Arizona Institute of Urology Completed
Tucson, Arizona, United States, 85704
El Dorado Urology & Prostate Center Withdrawn
Tucson, Arizona, United States, 85715
Urological Associates of Southern Arizona, P.C. Recruiting
Tucson, Arizona, United States, 85741
United States, California
CBCC Global Research Completed
Bakersfield, California, United States, 93309
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Tower Urology Recruiting
Los Angeles, California, United States, 90048
VA West Los Angeles Medical Center Completed
Los Angeles, California, United States, 90073
University of California, Irvine Recruiting
Orange, California, United States, 92868
San Bernardino Urological Associates Recruiting
San Bernardino, California, United States, 92404
Genesis Research Completed
San Diego, California, United States, 92123
California Pacific Medical Center Completed
San Francisco, California, United States, 94115
Department of Radiation Oncology UCSF Not yet recruiting
San Francisco, California, United States, 98115
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
The Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
United States, Connecticut
CT Clinical Research Center Recruiting
Middlebury, Connecticut, United States, 6762
United States, Florida
Manatee Medical Research Center Recruiting
Bradenton, Florida, United States, 34205
Atlantic Urology Associates Recruiting
Daytona Beach, Florida, United States, 32114
21st Century Oncology Completed
Fort Myers, Florida, United States, 33908
Urology Specialists LLC Recruiting
Hialeah, Florida, United States, 33002
21st Century Oncology Recruiting
Lakewood Ranch, Florida, United States, 34202
21st Century Oncology Recruiting
Naples, Florida, United States, 34102
21st Century Oncology Recruiting
Plantation, Florida, United States, 33324
United States, Idaho
Saint Alphonsus Regional Medical Center- Cancer Care Center Withdrawn
Boise, Idaho, United States, 83706
Idaho Urologic Institute Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
Research by Design, LLC Completed
Evergreen Park, Illinois, United States, 60805
Monroe Medical Associates Ingalls Recruiting
Harvey, Illinois, United States, 60426
United States, Indiana
First Urology Recruiting
Jeffersonville, Indiana, United States, 47130
United States, Kansas
Wichita Urology Group Recruiting
Wichita, Kansas, United States, 67226
United States, Kentucky
Ashland-Bellfonte Cancer Center Recruiting
Ashland, Kentucky, United States, 41101
University of Kentucky Medical Center Withdrawn
Lexington, Kentucky, United States, 40536
United States, Louisiana
Tulane University, Office of Clinical Research Recruiting
New Orleans, Louisiana, United States, 70112
Regional Urology Recruiting
Shreveport, Louisiana, United States, 71106
United States, Maine
New England Cancer Specialists Completed
Scarborough, Maine, United States, 4074
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Chesapeake Urology Research Associates Recruiting
Owings Mills, Maryland, United States, 21117
United States, Massachusetts
Massachusetts General Recruiting
Boston, Massachusetts, United States, 2114
United States, Michigan
21st Century Oncology Withdrawn
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Washington University of St Louis- Alvin J Siteman Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 7960
United States, New York
The Urological Institute of Northeastern New York Recruiting
Albany, New York, United States, 12208
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Brooklyn Urology Research Group Recruiting
Brooklyn, New York, United States, 11201
AccuMed Research Associates Withdrawn
Garden City, New York, United States, 11530
NYU University Urology Completed
New York, New York, United States, 100016
Premier Medical Group Recruiting
Poughkeepsie, New York, United States, 12601
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Associated Medical Professionals Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Cary Urology PA Completed
Cary, North Carolina, United States, 27511
University of North Carolina Withdrawn
Chapel Hill, North Carolina, United States, 27599
Alliance Urology Specialists Withdrawn
Greensboro, North Carolina, United States, 27403
Associated Urologists of North Carolina Completed
Raleigh, North Carolina, United States, 27612
Coastal Carolina Radiation Oncology Withdrawn
Wilmington, North Carolina, United States, 28401
United States, Ohio
TriState Urologic Services PSC Inc. DBA The Urology Group Withdrawn
Cincinnati, Ohio, United States, 45212
University Hospitals Case Medical Center Withdrawn
Cleveland, Ohio, United States, 44106
Signal Point Hematology Oncology Withdrawn
Middletown, Ohio, United States, 45042
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239-3098
Oregon Urology Institute Recruiting
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Urologic Consultants of SE PA Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
Urology Health Specialists, LLC Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Lancaster Urology Recruiting
Lancaster, Pennsylvania, United States, 17604
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Omega Medical Research Recruiting
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Charleston Hematology Oncology Completed
Charleston, South Carolina, United States, 29414
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Urology Associates Recruiting
Nashville, Tennessee, United States, 37209
Vanderbilt University Withdrawn
Nashville, Tennessee, United States, 37235
United States, Texas
Urology Clinics of North Texas Completed
Dallas, Texas, United States, 75231
Texas Oncology P.A. Completed
Houston, Texas, United States, 77024
Houston Metro Urology Recruiting
Houston, Texas, United States, 77027
Houston Methodist Cancer Center Recruiting
Houston, Texas, United States, 77030
Urology San Antonio Research Completed
San Antonio, Texas, United States, 78229
United States, Virginia
INOVA Dwiight &Martha Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22031
Sentara Rockingham Memorial Hospital Hahn Cancer Center Withdrawn
Harrisonburg, Virginia, United States, 22801
Urology of Virginia, PLCC Recruiting
Virginia Beach, Virginia, United States, 23462
United States, Washington
Seattle Urology Research Center Recruiting
Burien, Washington, United States, 98166
Medical Oncology Associates, PS Completed
Spokane, Washington, United States, 99208-1129
United States, West Virginia
West Virginia University Medical Center Completed
Morgantown, West Virginia, United States, 26506
Fundación Investigar Recruiting
C.a.b.a., Argentina, C1025ABI
Instituto Medico Alexander Fleming Recruiting
C.a.b.a., Argentina, C1426ANZ
Hospital Militar Cosme Argerich Recruiting
C.a.b.a., Argentina, C1426BOR
Centro de Urologia (CDU) Recruiting
Caba, Argentina, C1120AAT
Fundacion Favaloro Not yet recruiting
Ciudad Autonoma De Buenos Aires, Argentina, C1093AAS
Centro de Investigacion Pergamino SA Recruiting
Pergamino, Argentina, B2700CPM
Sanatorio Britanico de Rosario Recruiting
Rosario, Argentina, 2000
Instituto de Oncologia de Rosario (IOR) Recruiting
Rosario, Argentina, S2000KZE
ARS Médica Recruiting
San Salvador De Jujuy, Argentina, Y4600AFW
Clínica Viedma Withdrawn
Viedma, Argentina, R8500ACE
OLV Ziekenhuis Aalst Recruiting
Aalst, Belgium, 9300
Imelda Bonheiden Completed
Bonheiden, Belgium, 2820
UCL St Luc Recruiting
Brussel, Belgium, B-1200
Jolimont Recruiting
Haine-St-Paul, Belgium, 7100
UZ Leuven Recruiting
Leuven, Belgium, 3000
Sart Tilman Recruiting
Liège, Belgium, 4000
Clinique et Maternité Sainte Elisabeth Completed
Namur, Belgium, 5000
Algemeen Ziekenhuis Delta Recruiting
Roeselare, Belgium, 8800
AZ Nikolaas Completed
Sint-Niklaas, Belgium, 9100
AZ Turnhout Recruiting
Turnhout, Belgium, 2300
GZA Ziekenhuis Recruiting
Wilrijk, Belgium, 2610
Fundacao Pio Xii - Hospital De Cancer De Barretos Recruiting
Barretos, Brazil, 14784-400
Cetus Oncologia Recruiting
Belo Horizonte, Brazil, 30150-270
Instituto Mario Penna Recruiting
Belo Horizonte, Brazil, 30380-472
Instituto do Radium de Campinas Ltda. Recruiting
Campinas, Brazil, 13075-460
Hospital Erasto Gaertner Recruiting
Curitiba, Brazil, 81520-060
Centro de Pesquisas Oncológicas - CEPON Recruiting
Florianópolis, Brazil, 88034-000
Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás Recruiting
Goiânia, Brazil, 74605-070
Hospital de Caridade de Ijui - CACON Recruiting
Ijui, Brazil, 98700-000
Liga Norte Riograndense Contra O Cancer Recruiting
Natal, Brazil, 59075-740
Irmandade Santa Casa de Misericordia de Porto Alegre Recruiting
Porto Alegre, Brazil, 90020-090
IRPCC - Instituto Ribeiraopretano de Combate ao Cancer Recruiting
Ribeirao Preto, Brazil, 14015-130
Instituto Nacional do Cancer - INCA Recruiting
Rio De Janeiro, Brazil, 20231-050
Hospital Universitário Pedro Ernesto Recruiting
Rio De Janeiro, Brazil, 20551-030
Instituto COI de Pesquisa, Educação e Gestão Recruiting
Rio De Janeiro, Brazil, 22793-080
Hospital Santa Isabel Recruiting
Salvador, Brazil, 40050-410
Núcleo de Oncologia da Bahia Recruiting
Salvador, Brazil, 42700-000
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia Recruiting
Santo André, Brazil, 09060-650
Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto Recruiting
Sao Jose Do Rio Preto, Brazil, 15090-000
Centro de Pesquisa do Instituto do Cancer Arnaldo Vieira de Carvalho Recruiting
Sao Paulo, Brazil, 01221-020
Santa Casa de Misericordia de São Paulo Recruiting
Sao Paulo, Brazil, 01221-020
IBCC Instituto Brasileiro de Controle do Cancer Recruiting
Sao Paulo, Brazil, 03102-002
Hospital Santa Marcelina Recruiting
Sao Paulo, Brazil, 08270-070
Centro de Estudos e Pesquisas Oncologicas de Sorocaba (Instituto de Oncologia de Sorocaba) Recruiting
Sorocaba, Brazil, 18030-075
Sociedade Hospital Samaritano Recruiting
São Paulo, Brazil, 01232-010
Instituto de Estudo e Pesquisa Sao Lucas Recruiting
São Paulo, Brazil, 01236-030
ICESP - Instituto do Câncer do Estado de São Paulo Recruiting
São Paulo, Brazil, 01246-000
Hospital Sirio Libanes Recruiting
São Paulo, Brazil, 01308-050
Fundação Antônio Prudente - A.C. Camargo Cancer Center Recruiting
São Paulo, Brazil, 01509-900
Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO Recruiting
São Paulo, Brazil, 04039-004
Hospital Israelita Albert Einstein Recruiting
São Paulo, Brazil, 05651-900
Canada, Alberta
Tom Baker Cancer Center, University of Calgary Completed
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BC Cancer Agency, Fraser Valley Cancer Centre (FVCC) Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency (BCCA) - Vancouver Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer Agency - Vancouver Island Centre Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre Withdrawn
St. John'S, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre) Withdrawn
Kingston, Ontario, Canada, K7L 5P9
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Center Recruiting
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CISSS de l'Outaouais Recruiting
Gatineau, Quebec, Canada, J8P 7H2
Hopital de la Cite de la Sante - Centre integre de cancerologie de Laval (CICL) Recruiting
Laval, Quebec, Canada, H7M 3L9
McGill University - Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Hopital Maisonneuve-Rosemont Recruiting
Montréal, Quebec, Canada, H1T 2M4
CHUM - Centre hospitalier universitaire de Montreal Recruiting
Montréal, Quebec, Canada, H2X 3E4
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Allan Blair Cancer Centre, Paqua Hospital Withdrawn
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan Withdrawn
Saskatoon, Saskatchewan, Canada, S7N 4H4
CHUQ - CHU de Quebec Recruiting
Quebec, Canada, G1R 2J6
Peking University First Hospital Recruiting
Beijing, China, 100034
Beijing Friendship Hospital Recruiting
Beijing, China, 100050
Peking University Third Hospital Recruiting
Beijing, China, 100083
Beijing Cancer Hospital of Peking University Recruiting
Beijing, China, 100142
Beijing Hospital Recruiting
Beijing, China, 100730
Peking Union Medical College Hospital Withdrawn
Beijing, China, 100730
Hunan Cancer hospital Withdrawn
Changsha, China, 410013
The people's Hospital of Sichuan Province Recruiting
Chengdu, China, 610072
Chongqing Cancer hospital Recruiting
Chongqing, China, 400030
Sun Yat-Sen University Cancer Center Withdrawn
Guangzhou, China, 430030
Guangzhou First Municipal People's Hospital Recruiting
Guangzhou, China, 510180
The Second Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, China, 310009
Zhejiang Cancer Hospital Recruiting
Hangzhou, China, 310015
The First Affliated Hospital Of Nanchang University Recruiting
Nanchang, China, 330006
Jiangsu Cancer Hospital Recruiting
Nanjing, China, 210000
Nanjing Drum Tower Hospital Recruiting
Nanjing, China, 210008
Drug clinical trial ethics committee of Ningbo First Hospital Recruiting
Ningbo, China, 315010
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Shanghai Zhongshan Hospital Withdrawn
Shanghai, China, 200032
ShangHai Huadong Hospital Recruiting
Shanghai, China, 200040
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200092
ShangHai Changhai Hospital Withdrawn
Shanghai, China, 200433
Shanghai No. 1 Hospital Recruiting
Shanghai, China, 201620
First Hospital of Shanxi Medical University Withdrawn
Taiyuan, China, 030001
Wuhan Tongji Hospital, Tongji Medical College Recruiting
Wuhan, China, 430030
First Affiliated Hospital, Xi'an Jiaotong University Recruiting
Xi'An, China, 710004
Fakultní nemocnici Brno Withdrawn
Brno, Czechia, 625 00
Fakultni nemocnice Hradec Kralove Recruiting
Hradec Králove, Czechia, 500 05
Krajská nemocnice Liberec Recruiting
Liberec, Czechia, 460 63
Nemocnice Novy Jicin a.s., oddeleni radioterapie a onkologie Recruiting
Nový Jicin, Czechia, 741 01
Uromedical Center s.r.o. Recruiting
Olomouc, Czechia, 77900
Slezska nemocnice v Opave Recruiting
Opava, Czechia, 746 01
Onkologicke Centrum Multiscan Recruiting
Pardubice, Czechia, 532 03
Fakultni nemocnice Kralovske Vinohrady Recruiting
Praha 10, Czechia, 100 34
Urocentrum Praha Recruiting
Praha 2, Czechia, 120 00
Urologicka klinika 1.LF UK a VFN Recruiting
Praha 2, Czechia, 120 00
Thomayerova nemocnice Recruiting
Praha 4, Czechia, 140 59
Urologicka klinika 2.LF UK a FN Motol Recruiting
Praha 5, Czechia, 150 00
Nemocnice Na Bulovce Recruiting
Praha 8, Czechia, 180 00
Krajska Nemocnice T. Bati a.s. (KNTB) - Ambulance Urologicka Completed
Zlin, Czechia, 762 75
Clinique de l'Europe Recruiting
Amiens, France, 80090
Institut de Cancerologie de Ouest (ICO) Site Paul Papin Completed
Angers Cedex 02, France, 49055
Institut Sainte Catherine Recruiting
Avignon Cedex 9, France, 84918
Centre d'Oncologie et de Radiothérapie du Pays Basque Recruiting
Bayonne, France, 64100
CHRU De Besancon Recruiting
Besancon, France, 25030
Institut Bergonié Recruiting
Bordeaux, France, 33000
CHU Brest Recruiting
Brest, France, 29200
Centre d'oncologie et de radiothérapie du Parc Recruiting
Dijon, France, 21000
Centre Georges François Leclerc Recruiting
Dijon, France, 21000
Clinique Sainte Marguerite Recruiting
Hyères, France, 83400
Clinique Universitaire de cancérologie-Radiothérapie Recruiting
La Tronche, France, 38700
Centre Jean Bernard - Clinique Victor Hugo Recruiting
Le Mans, France, 72000
Centre Oscar Lambret Recruiting
Lille, France, 59020
Hopital La Timone Recruiting
Marseille Cedex 05, France, 13385
Hôpital Privé Clairval Recruiting
Marseilli, France, 13009
Institut Regional du Cancer de Montpellier Val d'Aurelle Recruiting
Montpellier, France, 34298
Hôpital Américain de Paris Recruiting
Neuilly-Sur-Seine, France, 92200
Hopital Privé des Peupliers Completed
Paris, France, 75013
Hopital Saint-Louis Recruiting
Paris, France, 75475
Institut du cancer courlancy Withdrawn
Reims, France, 51100
Centre de radiothérapie et d'Oncologie médicale de l'Essonne Recruiting
Ris Orangis, France, 91130
Institut de Cancérologie de l'Ouest (ICO) Recruiting
Saint Herblain, France, 44800
Clinique Armoricaine de Radiologie Completed
Saint-Brieuc, France, 22015
Hôpital d'Instruction des Armées BEGIN Recruiting
Saint-Mandé, France, 94160
Institut de Cancerologie Lucien Neuwirth Recruiting
Saint-Priest-En-Jarez, France, 42270
Strasbourg Oncologie Libérale Recruiting
Strasbourg, France, 67000
Clinique Pasteur Recruiting
Toulouse, France, 31300
CHRU Tours Hôpital Bretonneau Recruiting
Tours, France, 37000
Institut de Cancérologie de Lorraine Completed
Vandoeuvre-Les-Nancy, France, 54500
Hôpital Privé Océane Withdrawn
Vannes, France, 56000
Gustave Roussy Recruiting
Villejuif Cedex, France, 94800
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer Recruiting
Braunschweig, Germany, 38126
Zeisigwaldkliniken Bethanien Chemnitz Recruiting
Chemnitz, Germany, 9130
Diakonissenkrankenhaus Dessau Recruiting
Dessau, Germany, 6846
Universitatsklinikum Frankfurt Recruiting
Frankfurt, Germany, 60590
St. Antonius-Hospital Gronau GmbH Recruiting
Gronau, Germany, 48599
Universitätsklinikum Jena Recruiting
Jena, Germany, 7743
Klinik und Poliklinik für Urologie Withdrawn
Köln, Germany, 50937
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Studienpraxis Urologie Nürtingen Recruiting
Nürtingen, Germany, 72622
Gemeinschaftspraxis für Urologie in Traunstein Withdrawn
Traunstein, Germany, 83278
Universitaetsklinikum Ulm Recruiting
Ulm, Germany, 89081
Klinikum Weiden Recruiting
Weiden, Germany, 92637
Assaf Harofeh Medical Center Recruiting
Beer Yaakov, Israel, 73100
Soroka Medical Center Completed
Beer-Sheva, Israel, 84101
Rambam Medical Center Recruiting
Haifa, Israel, 35254
Hadassah Medical Organization Ein Kerem Recruiting
Jerusalem, Israel, 91120
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Rabin Medical Center Recruiting
Petach-Tikva, Israel, 49100
Sheba Medical Center Recruiting
Ramat-Gan, Israel, 52621
Sourasky (Ichilov) Medical Center Recruiting
Tel-Aviv, Israel, 64239
Reparto di Radioterapia Centro di Riferimento Oncologico Recruiting
Aviano, Italy, 33081
Radioterapia Oncologica, A.O.U. San'T Orsola Recruiting
Bologna, Italy, 40138
Istituto del Radio Olindo Alberti Spedali Civili Brescia Recruiting
Brescia, Italy, 25123
Istituto Ricerca Contro il Cancro Recruiting
Candiolo, Italy, 10060
Humanitas Centro Catanese di Oncologia Recruiting
Catania, Italy, 95126
Azienda Ospedaliero Universitaria Careggi Recruiting
Firenze, Italy, 50134
Ospedale San Raffaele Completed
Milano, Italy, 20132
Istituto Europeo di Oncologia Servizio Radioterapia Recruiting
Milano, Italy, 20141
Fondazione IRCCS Istituto Nazionale dei Tumori Completed
Napoli, Italy, 80131
Ospedale Sacro Cuore Negrar-Verona Recruiting
Negrar, Italy, 37024
U.O.Radioterapia Oncologica, Azienda Ospedaliera Di Perugia Recruiting
Perugia, Italy, 06156
Irccs Crob Completed
Rionero In Vulture, Italy, 85028
Università Campus Biomedico di Roma Recruiting
Roma, Italy, 00128
Fondazione Policlinico Tor Vergata Recruiting
Roma, Italy, 00133
Istituto Regina Elena, Roma Recruiting
Roma, Italy, 00144
Gemelli Art ,Università Cattolica S.Cuore Recruiting
Roma, Italy, 00168
Azienda Ospedaliera Sant Andrea Recruiting
Roma, Italy, 00189
Istituto Clinico Humanitas Recruiting
Rozzano, Italy, 20089
Korea, Republic of
Kyungpook National University Chilgok Hospital Recruiting
Daegu, Korea, Republic of, 41404
Chonnam National University Hwasun Hospital Recruiting
Hwasun-Gun, Korea, Republic of, 519-809
Seoul National University Bundang Hospital Recruiting
Seongnam-Si, Gyeonggi-Do, Korea, Republic of, 13620
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135 710
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 443-721
University Kebangsaan Malaysia Medical Centre Withdrawn
Cheras, Malaysia, 56000
Pulau Pinang Hospital Recruiting
Georgetown, Malaysia, 10990
Hospital University Sains Malaysia Withdrawn
Kota Bharu, Malaysia, 15600
Hospital Kuala Lumpur Recruiting
Kuala Lumpur, Malaysia, 50586
University Malaya Medical Centre Withdrawn
Kuala Lumpur, Malaysia, 59100
Sarawak General Hospital Recruiting
Kuching, Malaysia, 93586
National Cancer Institute Recruiting
Putrajaya, Malaysia, 62250
Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C. 'SINACOR' Recruiting
Culiacan, Mexico, 80230
Hospital Civil Fray Antonio Alcalde Recruiting
Guadalajara, Mexico, 44280
Hospital Aranda de la Parra S.A. de C.V. Recruiting
Leon, Mexico, 37000
Centro Medico Nacional Siglo XXI IMSS Recruiting
Mexico, Mexico, 06720
Clinica Lomas Altas Withdrawn
Mexico, Mexico, 11950
Instituto Nacional de Cancerologia Withdrawn
Mexico, Mexico, 14080
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán Not yet recruiting
Mexico, Mexico, 14080
Centro de Investigacion Clinica Chapultepec Recruiting
Morelia, Mexico, 58260
Centro Oncologico Estatal ISSEMYM Withdrawn
Toluca, Mexico, 50180
Consultorio Medico Recruiting
Zapopan, Mexico, 45040
Mc Alkmaar Completed
Alkmaar, Netherlands, 1815 JD
NKI-AVL, Amsterdam Completed
Amsterdam, Netherlands, 1066 CX
VUMC Amsterdam Recruiting
Amsterdam, Netherlands, 1081 HV
Rijnstate Ziekenhuis Withdrawn
Arnhem, Netherlands, 6815 AD
MC Haaglanden Completed
Den Haag, Netherlands, 2512 VA
Catharinaziekenhuis Withdrawn
Eindhoven, Netherlands, 5623 EJ
Spaarne Gasthuis Withdrawn
Hoofddorp, Netherlands, 2134 TM
UMC St. Radboud Completed
Nijmegen, Netherlands, 6525 GA
Canisius-Wilhelminaziekenhuis Completed
Nijmegen, Netherlands, 6532 SZ
Erasmus MC Recruiting
Rotterdam, Netherlands, 3075 EA
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku Recruiting
Bialystok, Poland, 15-027
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy Recruiting
Bydgoszcz, Poland, 85-796
Szpitale Pomorskie Sp. z o.o. Recruiting
Gdynia, Poland, 81-519
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Gliwicach Recruiting
Gliwice, Poland, 44-101
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Completed
Kielce, Poland, 25-734
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Recruiting
Lodz, Poland, 93-513
SPZOZ Ministerstwa Spraw Wewnętrznych z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Recruiting
Olsztyn, Poland, 10-228
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie w Poznaniu Recruiting
Poznan, Poland, 61-866
Affidea Onkoterapia Sp z o.o.- Miedzynarodowe Centrum Onkologii Recruiting
Walbrzych, Poland, 58-309
Institutul Oncologic Prof.Dr.Al.Trestioreanu Bucuresti Recruiting
Bucuresti, Romania, 022328
Institut Clinic Fundeni Withdrawn
Bucuresti, Romania, 22328
Institut Clinic Fundeni Recruiting
Bucuresti, Romania, 22328
Prof. Dr. Theodor Burghele Clinical Hospital Recruiting
Bucuresti, Romania, 50659
Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca Recruiting
Cluj-Napoca, Romania, 400015
Medisprof SRL Withdrawn
Cluj-Napoca, Romania, 400058
Radiotherapy Center Cluj Recruiting
Floresti, Romania, 407280
Institutul Regional de Oncologie Iasi Recruiting
Iasi, Romania, 700483
RTC Radiology Therapeutic Center Recruiting
Otopeni, Romania, 75100
Spital Municipal Ploiesti Recruiting
Ploiesti, Romania, 100337
Spitalul Clinic Judetean Sibiu Completed
Sibiu, Romania, 550245
SC. Clinica Polisano SRL Withdrawn
Sibiu, Romania, 550253
Spitalul Clinic Judetean Mures Recruiting
Targu Mures, Romania, 540141
Spitalul Clinic Municipal de Urgenta Timisoara Completed
Timisoara, Romania, 300594
Russian Federation
Altai Regional Oncology Dispensary Recruiting
Barnaul, Russian Federation, 656049
Ivanovo Regional Oncology Dispensary Recruiting
Ivanovo, Russian Federation, 153040
FSBSI 'N. N. Blokhin Russian Cancer Research Center' Recruiting
Moscow, Russian Federation, 115478
Russian Scientific Center of Roentgenoradiology Recruiting
Moscow, Russian Federation, 117997
Moscow City Clinical Hospital # 62 Recruiting
Moscow, Russian Federation, 125130
Hertzen Oncology Research Institute Recruiting
Moscow, Russian Federation, 125284
Semashko Regional Clinical Hospital Recruiting
Nizhny Novgorod, Russian Federation, 603126
National Medical Radiological Research Center Recruiting
Obninsk, Russian Federation, 249036
Clinical Oncology Dispansary Recruiting
Omsk, Russian Federation, 644013
LLC Novaya Clinica Recruiting
Pyatigorsk, Russian Federation, 357500
Hospital for War Veterans Completed
Rostov-On-Don, Russian Federation, 344037
Regional Clinical Oncology Dispensary Recruiting
Ryazan, Russian Federation, 390011
Leningrad Regional Oncology Dispensary Recruiting
Saint-Petersburg, Russian Federation, 191104
City Oncology Dispensary Recruiting
Saint-Petersburg, Russian Federation, 197022
Republican Oncology Dispensary Recruiting
Saransk, Russian Federation, 430032
Regional Oncology Dispansary #2 Withdrawn
Saratov, Russian Federation, 410053
Oncologic Dispensary No.2 Withdrawn
Sochi, Russian Federation, 354057
Russian Scientific Center of Radiology and Surgical Technologies Recruiting
St Petersburg, Russian Federation, 197758
Tambov Regional Oncology Clinical Dispansary Recruiting
Tambov, Russian Federation, 392013
Multifunctional clinical medical center 'Medical city' Recruiting
Tyumen, Russian Federation, 625041
Bashkiria State Medical University Recruiting
Ufa, Russian Federation, 450000
Vologda Regional Oncological Dispensary Recruiting
Vologda, Russian Federation, 160012
Hosp. Univ. de Cruces Recruiting
Barakaldo, Spain, 48903
Hosp. Univ. Vall D Hebron Recruiting
Barcelona, Spain, 08035
Hosp. de La Santa Creu I Sant Pau Recruiting
Barcelona, Spain, 08041
Fund. Hosp. Prov De Castellon Recruiting
Castellon, Spain, 12002
Ico Hospitalet (catalan Institute Of Oncology) Recruiting
Hospitalet De Llobregat, Spain, 8907
Hosp. Univ. de Gran Canaria Dr. Negrin Recruiting
Las Palmas De Gran Canaria, Spain, 35010
Hosp. Univ. de La Princesa Recruiting
Madrid, Spain, 28006
Hosp. Univ. Ramon Y Cajal Recruiting
Madrid, Spain, 28034
Hosp. Univ. 12 de Octubre Recruiting
Madrid, Spain, 28041
Centro Integral Oncológico Clara Campal Recruiting
Madrid, Spain, 28050
Hosp. Virgen de La Victoria Recruiting
Málaga, Spain, 29010
Hosp. Univ. Sant Joan De Reus Recruiting
Reus, Spain, 43204
Hosp. Clinico Univ. de Santiago Recruiting
Santiago De Compostela, Spain, 15706
Hosp. Virgen Del Rocio Recruiting
Sevilla, Spain, 41013
Onkologiska kliniken Radiumhemmet Recruiting
Stockholm, Sweden, 17176
Urologiska kliniken Recruiting
Umeå, Sweden, 90185
Urologiska kliniken Örebro Recruiting
Örebro, Sweden, 70185
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 81362
Chang Gung Memorial Hospital Completed
Kaohsiung, Taiwan, 83301
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70403
National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 10002
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 33305
Başkent University Medical Faculty Adana Application and Research Center Recruiting
Adana, Turkey, 01250
Hacettepe University Medical Faculty Recruiting
Ankara, Turkey, 06100
Gazi University Medical Faculty Recruiting
Ankara, Turkey, 06560
Ataturk Training and Research Hospital Recruiting
Ankara, Turkey, 06800
Trakya University Medical Faculty Recruiting
Edirne, Turkey, 22030
Istanbul University Cerrahpasa Medical Faculty Recruiting
Istanbul, Turkey, 34098
Ege Universitesi Tip Fakultesi Recruiting
İzmir, Turkey, 35040
Izmır Medical Park Hospital Recruiting
İzmir, Turkey, 35580
Erciyes University Medical Faculty Recruiting
Kayseri, Turkey, 38039
Kocaeli University Medical Faculty Recruiting
Kocaeli, Turkey, 41380
Dnipropetrovsk State Medical Academy, Dnipropetrovk State Clinical Hospital NA Mechnikov I.I. Recruiting
Dnipro, Ukraine, 49005
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4 Recruiting
Dnipro, Ukraine, 49102
Municipal non-profit enterprise 'Regional Center of Oncology' Recruiting
Khakhiv, Ukraine, 61070
State Institution National Cancer Institute Recruiting
Kyiv, Ukraine, 03022
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center Recruiting
Kyiv, Ukraine, 03115
Lviv Clinical Regional Hospital Recruiting
Lviv, Ukraine, 79031
United Kingdom
Aberdeen Royal Infirmary Recruiting
Aberdeen, United Kingdom, AB25 2ZB
University Hospitals Birmingham NHS Trust, Recruiting
Birmingham, United Kingdom, B15 2PR
Royal Blackburn Hospital Withdrawn
Blackburn, United Kingdom, BB2 3HH
Bristol Haematology and Oncology Centre Recruiting
Bristol, United Kingdom, BS2 8ED
Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Beatson West Of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom, G84 7SSE
Churchill Hospital Recruiting
Oxford, United Kingdom, OX3 7LE
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8qh
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital Recruiting
Preston, United Kingdom, PR2 9HT
The University Of Sheffield, Weston Park Hospital Recruiting
Sheffield, United Kingdom, S10 2SJ
Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM2 5PT
New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Aragon Pharmaceuticals, Inc.
Study Director: Aragon Pharmaceuticals, Inc. Clinical Trial Aragon Pharmaceuticals, Inc.

Additional Information:
Responsible Party: Aragon Pharmaceuticals, Inc. Identifier: NCT02531516     History of Changes
Other Study ID Numbers: CR106935
56021927PCR3003 ( Other Identifier: Aragon Pharmaceuticals, Inc. )
2015-003007-38 ( EudraCT Number )
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aragon Pharmaceuticals, Inc.:
Prostatic neoplasms
Prostate Cancer
High-Risk prostate cancer
Long-term hormone therapy
Localized or locally advanced prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Diseases, Male
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents