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Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Nonmetastatic Castration-resistant Prostate Cancer (ARAMIS)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02200614
Recruitment Status : Active, not recruiting
First Posted : July 25, 2014
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Bayer

Brief Summary:
The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Non-Metastatic Castration-Resistant Drug: Darolutamide (BAY1841788) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1509 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Actual Study Start Date : September 12, 2014
Actual Primary Completion Date : September 3, 2018
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Darolutamide (BAY1841788)
Metastasis-free survival (MFS) in patients with high-risk non-metastatic castration-resistant prostate cancer
Drug: Darolutamide (BAY1841788)
Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.

Placebo Comparator: Placebo
Metastasis-free survival (MFS) in patients with high-risk non-metastatic castration-resistant prostate cancer
Drug: Placebo
Matching placebo 2 tablets twice daily with food.




Primary Outcome Measures :
  1. Metastasis-Free Survival [ Time Frame: Up to 72 months ]
    Time from randomisation to evidence of metastasis or death from any cause, whichever occurs first


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 72 months ]
    Date of death and primary cause of death will be recorded

  2. Time to first symptomatic skeletal event (SSE) [ Time Frame: Up to 72 months ]
    Date of first SSE will be recorded

  3. Time to initiation of first cytotoxic chemotherapy for prostate cancer [ Time Frame: Up to 72 months ]
    Name and start date of cytotoxic chemotherapy treatment will be recorded

  4. Time to pain progression [ Time Frame: Up to 72 months ]
    Date of pain progression will be recorded

  5. Safety and tolerability of ODM-201 [ Time Frame: Up to 72 months ]
    Summaries of AEs, the frequency of discontinuation of study treatment due to AEs, laboratory evaluations, vital signs, ECGs and physical examination.



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

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
  • Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
  • Prostate-specific antigen doubling time of ≤ 10 months and PSA > 2ng/ml.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.
  • Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
  • Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.

Exclusion Criteria:

  • History of metastatic disease at any time or presence of detectable metastases.
  • Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
  • Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.
  • Use of estrogens or 5-α reductase inhibitors or AR inhibitors.
  • Prior chemotherapy or immunotherapy for prostate cancer.
  • Use of systemic corticosteroid.
  • Radiation therapy within 12 weeks before randomisation.
  • Severe or uncontrolled concurrent disease, infection or co-morbidity.
  • Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.
  • Known hypersensitivity to the study treatment or any of its ingredients.
  • Major surgery within 28 days before randomisation.
  • Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
  • Uncontrolled hypertension.
  • Prior malignancy.
  • Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
  • Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
  • Treatment with any investigational drug within 28 days before randomisation.
  • Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.

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 ClinicalTrials.gov identifier (NCT number): NCT02200614


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Locations
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United States, Alabama
Homewood, Alabama, United States, 35209
United States, Alaska
Anchorage, Alaska, United States, 99503
United States, Arizona
Tucson, Arizona, United States, 85704
United States, California
Fountain Valley, California, United States, 92708
La Jolla, California, United States, 92093
Laguna Hills, California, United States, 92653
Los Angeles, California, United States, 90048
Los Angeles, California, United States, 90073-1003
San Diego, California, United States, 92120
Whittier, California, United States, 90603
United States, Colorado
Denver, Colorado, United States, 80211
Denver, Colorado, United States, 80220
Parker, Colorado, United States, 80134
United States, Florida
Boca Raton, Florida, United States, 33486
Orlando, Florida, United States, 32803
Port Saint Lucie, Florida, United States, 34952
United States, Idaho
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Chicago, Illinois, United States, 60612
Evanston, Illinois, United States, 60201-1613
Springfield, Illinois, United States, 62702
United States, Indiana
Greenwood, Indiana, United States, 46143
Indianapolis, Indiana, United States, 46202
Jeffersonville, Indiana, United States, 47130
United States, Iowa
West Des Moines, Iowa, United States, 50266
United States, Kansas
Wichita, Kansas, United States, 67226
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Maryland
Annapolis, Maryland, United States, 21401
Baltimore, Maryland, United States, 21204
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Michigan
Grand Rapids, Michigan, United States, 49546
Royal Oak, Michigan, United States, 48073
United States, Nebraska
Omaha, Nebraska, United States, 68114
Omaha, Nebraska, United States, 68130
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756-0001
United States, New Jersey
Voorhees, New Jersey, United States, 08043
United States, New York
Bronx, New York, United States, 10461
Bronx, New York, United States, 10469
Syracuse, New York, United States, 13210
United States, North Carolina
Asheboro, North Carolina, United States, 27203
Charlotte, North Carolina, United States, 28277
United States, Ohio
Canton, Ohio, United States, 44718
Cincinnati, Ohio, United States, 45212
Cleveland, Ohio, United States, 44195
Gahanna, Ohio, United States, 43230
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Bala-Cynwyd, Pennsylvania, United States, 19004
Bryn Mawr, Pennsylvania, United States, 19010
United States, South Carolina
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Nashville, Tennessee, United States, 37209
United States, Texas
Dallas, Texas, United States, 75231
United States, Virginia
Fairfax, Virginia, United States, 22031
Richmond, Virginia, United States, 23235
Virginia Beach, Virginia, United States, 23462
United States, West Virginia
Wheeling, West Virginia, United States, 26003
Argentina
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1120AAT
Santa Fé, Santa Fe, Argentina, S3000FFV
San Miguel de Tucumán, Tucuman, Argentina, T4000HXU
Córdoba, Argentina, X5000HXL
Córdoba, Argentina, X5004FHP
Córdoba, Argentina, X5016KEH
La Rioja, Argentina, F5300COE
Australia, New South Wales
Randwick, New South Wales, Australia, 2031
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Douglas, Queensland, Australia, 4814
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Fitzroy, Victoria, Australia, 3065
Australia
Kurralta Park, Australia, 5037
Austria
Wien, Austria, 1020
Wien, Austria, 1090
Belarus
Lesnoy, Belarus, 223040
Minsk, Belarus, 220013
Belgium
Bonheiden, Belgium, 2820
Kortrijk, Belgium, 8500
Libramont, Belgium, 6800
Liege, Belgium, 4000
Sint-truiden, Belgium, 3800
Brazil
Salvador-Bahia, Bahia, Brazil, 40050-410
Fortaleza, Ceará, Brazil, 60430-230
Goiânia, Goiás, Brazil, 74605-070
Belo Horizonte, Minas Gerais, Brazil, 30150-320
Juiz de Fora, Minas Gerais, Brazil, 36010-510
Uberlandia, Minas Gerais, Brazil, 38408-150
Curitiba, Parana, Brazil, 81520-060
Recife, Pernambuco, Brazil, 50070-550
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-260
Porto Alegre, Rio Grande Do Sul, Brazil, 90050 170
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Itajaí, Santa Catarina, Brazil, 88301-220
Barretos, Sao Paulo, Brazil, 14784-400
Jau, Sao Paulo, Brazil, 17210-080
Ribeirao Preto - SP, Sao Paulo, Brazil, 14048-900
Sorocaba, Sao Paulo, Brazil, 18035-300
São Paulo, Sao Paulo, Brazil, 01209-000
São Paulo, Sao Paulo, Brazil, 01236-030
São Paulo, Sao Paulo, Brazil, 01246-000
São Paulo, Sao Paulo, Brazil, 03102 002
São Paulo, Sao Paulo, Brazil, 04039-004
Bulgaria
Sofia, Bulgaria, 1680
Varna, Bulgaria, 9000
Canada, Alberta
Calgary, Alberta, Canada, T2V 1P9
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Burlington, Ontario, Canada, L7N 3V2
Hamilton, Ontario, Canada, L8N 4A6
Kingston, Ontario, Canada, K7L 3J7
London, Ontario, Canada, N6A 5W9
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Granby, Quebec, Canada, J2G 8Z9
Pointe-Claire, Quebec, Canada, H9R 4S3
Colombia
Medellín, Antioquia, Colombia, 050034
Montería, Córdoba, Colombia, 230002
Floridablanca, Santander, Colombia, 681004
Czechia
Jablonec nad Nisou, Czechia, 466 60
Kolin, Czechia, 280 00
Olomouc, Czechia, 775 20
Opava, Czechia, 746 01
Praha 2, Czechia, 120 00
Praha 2, Czechia, 128 08
Praha 6, Czechia, 160 00
Praha 8, Czechia, 180 81
Estonia
Tallinn, Estonia, 13419
Finland
Helsinki, Finland, 00290
Kuopio, Finland, 70210
Seinäjoki, Finland, 60220
Tampere, Finland, 33521
Turku, Finland, FIN-20521
France
Angers, France, 49100
Bayonne, France, 64100
Besancon, France, 25030
Bordeaux Cedex, France, 33076
CAEN cedex 05, France, 14076
Cergy Pontoise, France, 95303
Clermont Ferrand Cedex 1, France, 63011
Creteil, France, 94010
Dijon, France, 21000
LA ROCHE SUR YON cedex, France, 85925
Limoges Cedex, France, 87042
Montpellier Cedex, France, 34295
Montpellier Cedex, France, 34298
Nancy, France, 54100
Nantes Cedex, France, 44093
Paris, France, 75010
Paris, France, 75014
Pierre Benite, France, 69310
POITIERS cedex, France, 86021
REIMS cedex, France, 51726
Rennes Cedex, France, 35033
Rouen Cedex, France, 76031
Saint Mande, France, 94160
Strasbourg, France, 67000
Suresnes, France, 92151
Tours, France, 37044
Villejuif Cedex, France, 94805
Germany
Emmendingen, Baden-Württemberg, Germany, 79312
Kirchheim unter Teck, Baden-Württemberg, Germany, 73230
Mühlacker, Baden-Württemberg, Germany, 75417
Nürtingen, Baden-Württemberg, Germany, 72622
Reutlingen, Baden-Württemberg, Germany, 72764
Tübingen, Baden-Württemberg, Germany, 72076
Zirndorf, Bayern, Germany, 90513
Frankfurt, Hessen, Germany, 60590
Marburg, Hessen, Germany, 35039
Hagenow, Mecklenburg-Vorpommern, Germany, 19230
Herzberg Am Harz, Niedersachsen, Germany, 37412
Holzminden, Niedersachsen, Germany, 37603
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Köln, Nordrhein-Westfalen, Germany, 50937
Mülheim, Nordrhein-Westfalen, Germany, 45468
Münster, Nordrhein-Westfalen, Germany, 48149
Wuppertal, Nordrhein-Westfalen, Germany, 42103
Mainz, Rheinland-Pfalz, Germany, 55131
Magdeburg, Sachsen-Anhalt, Germany, 39120
Dresden, Sachsen, Germany, 01307
Berlin, Germany, 12200
Hamburg, Germany, 20246
Hamburg, Germany, 22081
Hungary
Budapest, Hungary, 1086
Budapest, Hungary, 1145
Budapest, Hungary, 1204
Debrecen, Hungary, 4032
Gyor, Hungary, 9023
Nyiregyhaza, Hungary, 4400
Szeged, Hungary, 6725
Szekszard, Hungary, 7100
Szolnok, Hungary, 5000
Zalaegerszeg, Hungary, 8900
Israel
Haifa, Israel, 35152
Italy
Chieti, Abruzzo, Italy, 66100
Catanzaro, Calabria, Italy, 88100
A.O.R.N. Antonio Cardarelli
Napoli, Campania, Italy, 80131
IRCCS INT Fondazione Pascale
Napoli, Campania, Italy, 80131
Forlì-Cesena, Emilia-Romagna, Italy, 47014
Modena, Emilia-Romagna, Italy, 41124
Parma, Emilia-Romagna, Italy, 43126
Roma, Lazio, Italy, 00144
Roma, Lazio, Italy, 00189
Torino, Piemonte, Italy, 10043
Torino, Piemonte, Italy, 10060
Lecce, Puglia, Italy, 73100
Messina, Sicilia, Italy, 98125
Palermo, Sicilia, Italy, 90127
Arezzo, Toscana, Italy, 52100
Japan
Nagoya, Aichi, Japan, 466-8560
Kashiwa, Chiba, Japan, 277-8577
Kurume, Fukuoka, Japan, 839-0863
Koriyama, Fukushima, Japan, 963-8052
Maebashi, Gunma, Japan, 371-8511
Otake, Hiroshima, Japan, 739-0696
Sapporo, Hokkaido, Japan, 060-8543
Kobe, Hyogo, Japan, 650-0047
Higashiibaraki, Ibaraki, Japan, 311-3193
Kanazawa, Ishikawa, Japan, 920-8530
Sagamihara, Kanagawa, Japan, 252-0375
Yokohama, Kanagawa, Japan, 232-0024
Yokosuka, Kanagawa, Japan, 238-8558
Sendai, Miyagi, Japan, 981-8563
Ueda, Nagano, Japan, 386-8610
Kashihara, Nara, Japan, 634-8522
Yufu, Oita, Japan, 879-5593
Osakasayama, Osaka, Japan, 589-8511
Wako, Saitama, Japan, 351-0102
Hamamatsu, Shizuoka, Japan, 431-3192
Utsunomiya, Tochigi, Japan, 321-0974
Bunkyo-ku, Tokyo, Japan, 113-8431
Bunkyo-ku, Tokyo, Japan, 113-8603
Itabashi-ku, Tokyo, Japan, 173-0015
Minato-ku, Tokyo, Japan, 105-8471
Mitaka, Tokyo, Japan, 181-8611
Nakano-ku, Tokyo, Japan, 164-8541
Shinjuku-ku, Tokyo, Japan, 160-8582
Sumida-ku, Tokyo, Japan, 130-8587
Ube, Yamaguchi, Japan, 755-8505
Chiba, Japan, 260-8717
Fukui, Japan, 910-8526
Hiroshima, Japan, 730-8518
Kyoto, Japan, 602-8566
Nagasaki, Japan, 852-8501
Nagasaki, Japan, 852-8511
Okayama, Japan, 700-8558
Osaka, Japan, 541-8567
Osaka, Japan, 545-8586
Osaka, Japan, 558-8558
Toyama, Japan, 930-0194
Korea, Republic of
Donggu,, Gwangju Gwang''yeogsi, Korea, Republic of, 61469
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06273
Chungchungbuk-do, Korea, Republic of, 28644
Daegu, Korea, Republic of, 41404
Daegu, Korea, Republic of, 41931
Incheon, Korea, Republic of, 21565
Seoul, Korea, Republic of, 03080
Seoul, Korea, Republic of, 03722
Seoul, Korea, Republic of, 05505
Seoul, Korea, Republic of, 06351
Seoul, Korea, Republic of, 06591
Latvia
Daugavpils, Latvia, LV5401
Jelgava, Latvia, LV-3001
Leipaja, Latvia, LV-3401
Riga, Latvia, LV-1001
Riga, Latvia, LV-1002
Riga, Latvia, LV-1038
Lithuania
Kaunas, Lithuania, LT-45434
Kaunas, Lithuania, LT-50009
Klaipeda, Lithuania, LT-92288
Vilnius, Lithuania, LT-08660
Vilnius, Lithuania, LT-08661
Peru
La Victoria, Arequipa, Peru, 4001
Lima, Peru, 15046
Lima, Peru, 15073
San Isidro, Peru, 15036
Poland
Elblag, Poland, 82-300
Gdansk, Poland, 80-952
Lodz, Poland, 90-302
Lublin, Poland, 20-718
Otwock, Poland, 05-400
Rzeszow, Poland, 35-021
Siedlce, Poland, 08-110
Warszawa, Poland, 02-616
Warszawa, Poland, 02-781
Warszawa, Poland, 04-125
Wroclaw, Poland, 54-144
Portugal
Guimaraes, Braga, Portugal, 4835-044
Almada, Lisboa, Portugal, 2801-951
Matosinhos, Porto, Portugal, 4464-513
Braga, Portugal, 4710-243
Lisboa, Portugal, 1099-023
Lisboa, Portugal, 1150-199
Lisboa, Portugal, 1400-038
Lisboa, Portugal, 1500-650
Porto, Portugal, 4200-072
Porto, Portugal, 4200-319
Romania
Bucuresti, Romania, 22328
Bucuresti, Romania, 41345
Bucuresti, Romania, 50659
Bucuresti, Romania, 75000
Cluj-Napoca, Romania, 400015
Craiova, Romania, 200385
Craiova, Romania, 200642
Oradea, Romania, 410159
Ploiesti, Romania, 100337
Targu-Mures, Romania, 540103
Russian Federation
Chelyabinsk, Russian Federation, 454087
Ivanovo, Russian Federation, 153040
Kazan, Russian Federation, 420029
Krasnoyarsk, Russian Federation, 660133
Moscow, Russian Federation, 105425
Moscow, Russian Federation, 117997
Moscow, Russian Federation, 125284
Moscow, Russian Federation, 129301
Nizhny Novgorod, Russian Federation, 603006
Novosibirsk, Russian Federation, 630099
Obninsk, Russian Federation, 249036
Omsk, Russian Federation, 644013
Orenburg, Russian Federation, 460021
Pyatigorsk, Russian Federation, 357502
Rostov-on-Don, Russian Federation, 344022
Saratov, Russian Federation, 410012
St. Petersburg, Russian Federation, 191014
St. Petersburg, Russian Federation, 194017
St. Petersburg, Russian Federation, 194354
St. Petersburg, Russian Federation, 197022
Tyumen, Russian Federation, 625041
Ufa, Russian Federation, 450008
Vladimir, Russian Federation, 600020
Serbia
Belgrade, Serbia, 11000
Clin.Hosp.Cen. Bezanijska kosa
Belgrade, Serbia, 11080
Clinical Hospital Center Zemun
Belgrade, Serbia, 11080
Nis, Serbia, 18000
Slovakia
Bratislava, Slovakia, 851 01
Bratislava, Slovakia, 851 05
Martin, Slovakia, 036 59
Trencin, Slovakia, 91101
South Africa
Outeniqua Cancercare Oncology
George, Eastern Cape, South Africa, 6530
George, Eastern Cape, South Africa, 6530
Port Elizabeth, Eastern Cape, South Africa, 6045
Pretoria, Gauteng, South Africa, 0002
Pretoria, Gauteng, South Africa, 0083
Paarl, Western Cape, South Africa, 7646
Rondebosch, Western Cape, South Africa, 7700
Cape Town, South Africa, 7505
Cape Town, South Africa, 7925
Spain
Elche, Alicante, Spain, 03203
Cádiz, Andalucía, Spain, 11009
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Sabadell, Barcelona, Spain, 08208
Terrassa, Barcelona, Spain, 08221
Jerez de la Frontera, Cádiz, Spain, 11407
Manacor, Illes Baleares, Spain, 07500
Palma de Mallorca, Illes Baleares, Spain, 07120
Alcorcón, Madrid, Spain, 28922
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Bilbao, Spain, 48013
Córdoba, Spain, 14004
Granada, Spain, 18012
Lugo, Spain, 27003
Madrid, Spain, 28007
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Clínico San Carlos
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28046
Málaga, Spain, 29010
Salamanca, Spain, 37007
Sevilla, Spain, 41009
Sevilla, Spain, 41013
Valencia, Spain, 46009
Valencia, Spain, 46015
Valencia, Spain, 46026
Sweden
Göteborg, Sweden, 413 45
Stockholm, Sweden, 171 76
Uppsala, Sweden, 751 85
Örebro, Sweden, 701 85
Taiwan
Kaohsiung City ,, Taiwan, 807
Kaoshiung, Taiwan, 81362
Taichung, Taiwan, 40705
Taipei, Taiwan, 10002
Taoyuan, Taiwan, 333
Turkey
Ankara, Turkey, 06500
Istanbul, Turkey, 34730
Izmir, Turkey, 35100
Izmir, Turkey, 35340
Manisa, Turkey, 45030
Sivas, Turkey, 58140
Ukraine
Chernivtsi, Ukraine, 58002
Dnipro, Ukraine, 49102
Kharkiv, Ukraine, 61037
Kryvyi Rih, Ukraine, 50048
Kyiv, Ukraine, 04053
Kyiv, Ukraine, 2660
Uzhgorod, Ukraine, 88014
Zaporozhye, Ukraine, 69600
United Kingdom
Reading, Berkshire, United Kingdom, RG1 5AN
Llanelli, Carmarthenshire, United Kingdom, SA14 8QF
Romford, Essex, United Kingdom, RM7 0AG
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Dartford, Kent, United Kingdom, DA2 8DA
Maidstone, Kent, United Kingdom, ME16 9QQ
Preston, Lancashire, United Kingdom, PR2 4HT
Bebington, Merseyside, United Kingdom, CH63 4JY
Scunthorpe, North East Lincolnshire, United Kingdom, DN15 7BH
Bath, Somerset, United Kingdom, BA1 3NG
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Dudley, West Midlands, United Kingdom, DY1 2HQ
Huddersfield, West Yorkshire, United Kingdom, HD3 3EA
Wakefield, West Yorkshire, United Kingdom, WF1 4DG
Cardiff, United Kingdom, CF14 4XN
Glasgow, United Kingdom, G12 0YN
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
Bayer
Orion Corporation, Orion Pharma
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02200614     History of Changes
Other Study ID Numbers: 17712
2013-003820-36 ( EudraCT Number )
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases