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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. Identifier: NCT02799602
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : September 26, 2019
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):

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

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.

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

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 identifier (NCT number): NCT02799602

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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
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Washington, District of Columbia, United States, 20007-2197
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Boca Raton, Florida, United States, 33486
Gainesville, Florida, United States, 32608
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Atlanta, Georgia, United States, 30322
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Chicago, Illinois, United States, 60611
Peoria, Illinois, United States, 61615-7828
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Louisville, Kentucky, United States, 40202
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New Orleans, Louisiana, United States, 70112
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Baltimore, Maryland, United States, 21287
Towson, Maryland, United States, 21204
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Boston, Massachusetts, United States, 02111
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Detroit, Michigan, United States, 48202
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Billings, Montana, United States, 59102
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Omaha, Nebraska, United States, 68130-5606
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Englewood, New Jersey, United States, 07361
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Albuquerque, New Mexico, United States, 87109
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Bronx, New York, United States, 10467-2490
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Winston-Salem, North Carolina, United States, 27157
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Cleveland, Ohio, United States, 44106-2602
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Melbourne, Victoria, Australia, 3065
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Donggu,, Gwangju Gwang''yeogsi, Korea, Republic of, 61469
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
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Busan, Korea, Republic of, 47392
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Gyeonggi-do, Korea, Republic of, 11923
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México, D. F., Distrito Federal, Mexico, 06700
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Querétaro, Mexico, 76000
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Amsterdam, Netherlands, 1105 AZ
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Rybnik, Poland, 44-200
Siedlce, Poland, 08-110
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Warszawa, Poland, 02-781
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Chelyabinsk, Russian Federation, 454087
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 125284
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St. Petersburg, Russian Federation, 197136
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Madrid, Spain, 28041
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Valencia, Spain, 46009
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Stockholm, Sweden, 171 76
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Taichung, Taiwan, 40447
Taipei, Taiwan, 10002
Taipei, Taiwan, 11217
Taoyuan, Taiwan, 333
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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
Orion Corporation, Orion Pharma
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer 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: September 26, 2019
Last Verified: September 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
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Immune System Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs