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ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS)

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: NCT02799602
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Bayer

Brief Summary:
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: BAY1841788 / darolutamide (ODM-201) Drug: Standard ADT (androgen deprivation therapy) Drug: Docetaxel Drug: Placebo Phase 3

Detailed Description:

This is a randomized, double-blind, placebo-controlled, multicenter phase III study. The study population will consist of approximately 1300 subjects with metastatic hormone sensitive prostate cancer (mHSPC), who will be randomized (1:1 ratio) to receive 600 mg (2 x 300 mg tablets) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total daily dose of 1200 mg, in addition to standard androgen deprivation therapy (ADT) and docetaxel. Subjects will be stratified at randomization for the extent of disease and for Alkaline Phosphatase levels. All subjects will be treated with ADT as standard therapy. Six cycles of docetaxel will be administered after randomization.

The subjects considered for inclusion in the study will have metastatic prostate cancer and will be candidates for ADT and docetaxel.

Treatment with darolutamide (ODM-201)/placebo will be administered until symptomatic progressive disease, change of antineoplastic therapy, unacceptable toxicity, until subject withdraws consent, withdrawal from the study at the discretion of the Investigator or his/her designated associate(s), death, non-compliance, or if Sponsor terminates the study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer
Actual Study Start Date : November 30, 2016
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel
Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel
Drug: BAY1841788 / darolutamide (ODM-201)
600mg (2 tablets of 300 mg) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total a daily dose of 1200 mg in addition to standard ADT (luteinizing hormone releasing hormone (LHRH) agonist/antagonist or orchiectomy) and 6 cycles of docetaxel

Drug: Standard ADT (androgen deprivation therapy)
As prescribed by the treating physician.

Drug: Docetaxel
As prescribed by the treating physician.

Placebo Comparator: Placebo + standard ADT + Docetaxel
Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel
Drug: Standard ADT (androgen deprivation therapy)
As prescribed by the treating physician.

Drug: Docetaxel
As prescribed by the treating physician.

Drug: Placebo
Placebo matching darolutamide (ODM-201) tablets in appearance, bid orally with food, in addition to standard ADT (luteinizing hormone releasing hormone [LHRH] agonist/antagonist or orchiectomy) and 6 cycles of docetaxel.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: approximately 70 months ]
    From date of randomization until death from any cause, during treatment and during active and long term follow-up


Secondary Outcome Measures :
  1. Time to castration resistant prostate cancer [ Time Frame: approximately 70 months ]
    Approximately every 12 weeks (according to standards of care) up to the time of PSA progression by soft tissue/visceral lesions or progression by bone lesions, whatever come first.

  2. Time to initiation of subsequent antineoplastic therapy [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the date of first subsequent antineoplastic therapy for prostate cancer.

  3. Symptomatic skeletal event free survival (SSE-FS) [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the first occurrence of SSE or death from any cause, whatever comes first SSE is defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first.

  4. Time to first symptomatic skeletal event (SSE) [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the first occurrence of SSE. SSE is defined as EBRT to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first.

  5. Time to initiation of opioid use [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the opiod use.

  6. Time to pain progression [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the first date a subject experiences a pain progression. Pain to be assessed with a patient reported questionaire.

  7. Time to worsening of physical symptoms of disease [ Time Frame: approximately 70 months ]

    Every 12 weeks up to the first date a subject experiences an increase in physical symptoms.

    Physical symptoms of disease to be assessed with a patient reported questionaire.


  8. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: approximately 70 months ]


Information from the National Library of Medicine

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Layout table for eligibility information
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.
  • Metastatic disease
  • Candidates for ADT and docetaxel. Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201); other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer, chemotherapy or immunotherapy for prostate cancer prior to randomization.
  • Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
  • Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
  • Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 5 years before randomization and from which the subject has been disease-free
  • Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment.
  • Inability to swallow oral medications

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): NCT02799602


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Locations
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United States, Arizona
Chandler, Arizona, United States, 85224
Tucson, Arizona, United States, 85724
United States, California
Beverly Hills, California, United States, 90211-1850
Duarte, California, United States, 91010
Los Angeles, California, United States, 90073-1003
Stanford, California, United States, 94305-5820
United States, District of Columbia
Washington, District of Columbia, United States, 20007-2197
United States, Florida
Boca Raton, Florida, United States, 33486
Gainesville, Florida, United States, 32608
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60611
Peoria, Illinois, United States, 61615-7828
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Maryland
Baltimore, Maryland, United States, 21287
Towson, Maryland, United States, 21204
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Montana
Billings, Montana, United States, 59102
United States, Nebraska
Omaha, Nebraska, United States, 68130-5606
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756-0001
United States, New Jersey
Englewood, New Jersey, United States, 07361
Hackensack, New Jersey, United States, 07601
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Albuquerque, New Mexico, United States, 87109
United States, New York
Bronx, New York, United States, 10467-2490
Buffalo, New York, United States, 14263-0001
New York, New York, United States, 10032
Poughkeepsie, New York, United States, 12601
Rochester, New York, United States, 14642
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland, Ohio, United States, 44106-2602
Columbus, Ohio, United States, 43210
Columbus, Ohio, United States, 43221-2416
Kettering, Ohio, United States, 45409-1328
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Bala-Cynwyd, Pennsylvania, United States, 19004
Camp Hill, Pennsylvania, United States, 17011
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Charleston, South Carolina, United States, 29401-5799
Charleston, South Carolina, United States, 29414
Greenville, South Carolina, United States, 29607
Myrtle Beach, South Carolina, United States, 29572
North Charleston, South Carolina, United States, 29406
United States, Texas
Dallas, Texas, United States, 75231
Temple, Texas, United States, 76508
United States, Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Charlottesville, Virginia, United States, 22908
Fairfax, Virginia, United States, 22031
Richmond, Virginia, United States, 23219
United States, Washington
Everett, Washington, United States, 98201
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Randwick, New South Wales, Australia, 2031
Sydney, New South Wales, Australia, 2010
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Melbourne, Victoria, Australia, 3065
Australia
Kurralta Park, Australia, 5037
Belgium
Wilrijk, Antwerpen, Belgium, 2610
Bruxelles - Brussel, Belgium, 1000
Bruxelles - Brussel, Belgium, 1070
Bruxelles - Brussel, Belgium, 1200
Charleroi, Belgium, 6000
Gent, Belgium, 9000
Namur, Belgium, 5000
Brazil
Salvador, Bahia, Brazil, 41253-190
Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29308-020
Curitiba, Parana, Brazil, 81520-060
Natal, Rio Grande Do Norte, Brazil, 59062-000
Porto Alegre, Rio Grande Do Sul, Brazil, 90050 170
Santo André, Sao Paulo, Brazil, 09060-650
São Paulo, Sao Paulo, Brazil, 03102 002
Rio de Janeiro, Brazil, 20231-050
Rio de Janeiro, Brazil, 22793-080
Bulgaria
Gabrovo, Bulgaria, 5300
Pleven, Bulgaria, 5800
Sofia, Bulgaria, 1303
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1784
Varna, Bulgaria, 2010
Vratsa, Bulgaria, 3000
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H2L 4M1
China, Anhui
Hefei, Anhui, China, 230001
China, Fujian
Xiamen, Fujian, China, 361003
China, Guangdong
Guangzhou, Guangdong, China, 510120
China, Hebei
Shijiazhuang, Hebei, China, 050000
China, Henan
Zhengzhou, Henan, China, 450008
China, Hubei
Wuhan, Hubei, China, 430030
Wuhan, Hubei, China, 430079
China, Hunan
Changsha, Hunan, China, 410013
China, Jiangsu
Nanjing, Jiangsu, China, 210008
Nanjing, Jiangsu, China, 210009
China, Jiangxi
Nanchang, Jiangxi, China, 330006
China, Jilin
Changchun, Jilin, China, 130021
China, Liaoning
Shengyang, Liaoning, China, 110042
Shenyang, Liaoning, China, 110001
China, Shaanxi
Xi'an, Shaanxi, China, 710061
China, Shandong
Jinan, Shandong, China, 250012
Jinan, Shandong, China, 250021
Yantai, Shandong, China, 264000
China, Zhejiang
Hangzhou, Zhejiang, China, 310009
Hangzhou, Zhejiang, China, 310014
Wenzhou, Zhejiang, China, 325000
China
Beijing, China, 100034
Beijing, China, 100050
Beijing, China, 100142
Beijing, China, 100191
Beijing, China, 100730
Chongqing, China, 400030
Shanghai, China, 200032
Shanghai, China, 200040
Shanghai, China, 200072
Shanghai, China, 200080
Shanghai, China, 200092
Tianjin, China, 300052
Tianjin, China, 300060
Czechia
Brno, Czechia, 656 53
Brno, Czechia, 656 91
Praha 10, Czechia, 10034
Praha 2, Czechia, 120 00
Praha 2, Czechia, 128 08
Praha 5, Czechia, 150 06
Praha 8, Czechia, 180 01
Finland
Helsinki, Finland, 00290
Jyväskylä, Finland, 40620
Kuopio, Finland, 70210
Mikkeli, Finland, FIN-50100
Oulu, Finland, 90220
Tampere, Finland, 33521
Turku, Finland, 20520
France
Angers Cedex, France, 49933
Besancon, France, 25030
Bordeaux Cedex, France, 33076
Brest, France, 29200
Clermont-ferrand, France, 63011
Creteil, France, 94010
Marseille, France, 13273
Montpellier Cedex, France, 34298
Nancy, France, 54100
Pierre Benite, France, 69310
Poitiers, France, 86021
Pontoise, France, 95301
REIMS cedex, France, 51726
Saint Herblain Cedex, France, 44805
Saint-gregoire, France, 35760
Strasbourg, France, 67098
Villejuif Cedex, France, 94805
Germany
Freiburg, Baden-Württemberg, Germany, 79106
Reutlingen, Baden-Württemberg, Germany, 72766
Tübingen, Baden-Württemberg, Germany, 72076
Ulm, Baden-Württemberg, Germany, 89081
Erlangen, Bayern, Germany, 91054
Rostock, Mecklenburg-Vorpommern, Germany, 18107
Braunschweig, Niedersachsen, Germany, 38118
Münster, Nordrhein-Westfalen, Germany, 48149
Jena, Thüringen, Germany, 07740
Berlin, Germany, 12200
Magdeburg, Germany, 39120
Israel
Beer Sheva, Israel, 8410101
Haifa, Israel, 3109601
Holon, Israel, 5810001
Jerusalem, Israel, 9112001
Petah Tikva, Israel, 4941492
Tel Aviv, Israel, 6423906
Zefat, Israel, 1311001
Zerifin, Israel, 6093000
Italy
Bologna, Emilia-Romagna, Italy, 40138
Parma, Emilia-Romagna, Italy, 43126
Roma, Lazio, Italy, 00152
Milano, Lombardia, Italy, 20141
Novara, Piemonte, Italy, 28100
Torino, Piemonte, Italy, 10043
Trento, Trentino-Alto Adige, Italy, 38122
Padova, Veneto, Italy, 35128
Verona, Veneto, Italy, 37134
Japan
Nagoya, Aichi, Japan, 466-8560
Hirosaki, Aomori, Japan, 036-8563
Asahi, Chiba, Japan, 289-2511
Kashiwa, Chiba, Japan, 277-8577
Sakura, Chiba, Japan, 285-8741
Matsuyama, Ehime, Japan, 791-0280
Sapporo, Hokkaido, Japan, 003-0804
Kobe, Hyogo, Japan, 650-0017
Kanazawa, Ishikawa, Japan, 920-8530
Kanazawa, Ishikawa, Japan, 920-8641
Kita, Kagawa, Japan, 761-0793
Yokohama, Kanagawa, Japan, 232-0024
Yokohama, Kanagawa, Japan, 241-8515
Tsu, Mie, Japan, 514-8507
Sendai, Miyagi, Japan, 980-8574
Kashihara, Nara, Japan, 634-8522
Osakasayama, Osaka, Japan, 589-8511
Suita, Osaka, Japan, 565-0871
Hamamatsu, Shizuoka, Japan, 431-3192
Shimotsuke, Tochigi, Japan, 329-0498
Utsunomiya, Tochigi, Japan, 321-0974
Bunkyo-ku, Tokyo, Japan, 113-8431
Bunkyo-ku, Tokyo, Japan, 113-8603
Bunkyo-ku, Tokyo, Japan, 113-8655
Koto-ku, Tokyo, Japan, 135-8550
Meguro-ku, Tokyo, Japan, 152-8902
Minato-ku, Tokyo, Japan, 105-8471
Mitaka, Tokyo, Japan, 181-8611
Nakano-ku, Tokyo, Japan, 164-8541
Shinjuku-ku, Tokyo, Japan, 160-8582
Shinjuku-ku, Tokyo, Japan, 162-8543
Yonago, Tottori, Japan, 683-8504
Ube, Yamaguchi, Japan, 755-8505
Chiba, Japan, 260-8677
Chiba, Japan, 260-8717
Fukuoka, Japan, 811-1395
Gifu, Japan, 500-8717
Kumamoto, Japan, 860-0008
Miyazaki, Japan, 889-1692
Nagasaki, Japan, 852-8501
Okayama, Japan, 700-8558
Osaka, Japan, 541-8567
Osaka, Japan, 545-8586
Tokushima, Japan, 770-8503
Wakayama, Japan, 641-8509
Korea, Republic of
Donggu,, Gwangju Gwang''yeogsi, Korea, Republic of, 61469
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06273
Busan, Korea, Republic of, 614-735
Daegu, Korea, Republic of, 41404
Gyeonggi-do, Korea, Republic of, 471-701
Seoul, Korea, Republic of, 03080
Seoul, Korea, Republic of, 05505
Seoul, Korea, Republic of, 06351
Seoul, Korea, Republic of, 06591
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 136-705
Mexico
Ciudad de Mexico, Distrito Federal, Mexico, 06760
Mexico, Distrito Federal, Mexico, 06700
Cuernavaca, Morelos, Mexico, 62290
Monterrey, Nuevo Leon, Mexico, 64460
Mazatlán, Sinaloa, Mexico, 82110
Querétaro, Mexico, 76000
Netherlands
Amsterdam, Netherlands, 1066 CX
Amsterdam, Netherlands, 1105 AZ
Den Haag, Netherlands, 2545 CH
Dordrecht, Netherlands, 3318 AT
Heerlen, Netherlands, 6401 CX
Hilversum, Netherlands, 1213 XZ
Hoofddorp, Netherlands, 2134 TM
Tilburg, Netherlands, 5042 AD
Poland
Lodz, Poland, 93-513
Lublin, Poland, 20-362
Rybnik, Poland, 44-200
Siedlce, Poland, 08-110
Waliszew, Poland, 05-135
Warszawa, Poland, 02-781
Russian Federation
Barnaul, Russian Federation, 656049
Chelyabinsk, Russian Federation, 454048
Chelyabinsk, Russian Federation, 454087
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 125284
Novosibirsk, Russian Federation, 630099
Omsk, Russian Federation, 644013
St. Petersburg, Russian Federation, 191014
St. Petersburg, Russian Federation, 194017
St. Petersburg, Russian Federation, 197136
Spain
Sabadell, Barcelona, Spain, 08208
Palma de Mallorca, Illes Baleares, Spain, 07120
Barcelona, Spain, 08003
Barcelona, Spain, 08025
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Cáceres, Spain, 10003
Córdoba, Spain, 14004
Lugo, Spain, 27004
Madrid, Spain, 28034
Madrid, Spain, 28041
Málaga, Spain, 29010
Valencia, Spain, 46009
Sweden
Göteborg, Sweden, 413 45
Lund, Sweden, 221 85
Stockholm, Sweden, 171 76
Umeå, Sweden, 901 85
Uppsala, Sweden, 751 85
Taiwan
Kaohsiung, Taiwan, 807
Taichung, Taiwan, 40447
Taipei, Taiwan, 10002
Taipei, Taiwan, 11217
Taoyuan, Taiwan, 333
United Kingdom
Colchester, Essex, United Kingdom, CO4 5JR
Romford, Essex, United Kingdom, RM7 0AG
Middlesborough, North Yorkshire, United Kingdom, TS4 3BW
Belfast, United Kingdom, BT9 7AB
Glasgow, United Kingdom, G12 0YN
London, United Kingdom, NW1 2PG
London, United Kingdom, SW3 6JJ
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Bayer
Orion Corporation, Orion Pharma
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02799602     History of Changes
Other Study ID Numbers: 17777
2015-002590-38 ( EudraCT Number )
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Bayer:
Metastatic hormone sensitive prostate cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Hypersensitivity
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Immune System Diseases
Docetaxel
Hormones
Prolactin Release-Inhibiting Factors
Androgens
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs