ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS)
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ClinicalTrials.gov Identifier: NCT02799602 |
Recruitment Status :
Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : September 29, 2022
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Tracking Information | |||||||
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First Submitted Date ICMJE | June 6, 2016 | ||||||
First Posted Date ICMJE | June 15, 2016 | ||||||
Last Update Posted Date | September 29, 2022 | ||||||
Actual Study Start Date ICMJE | November 30, 2016 | ||||||
Actual Primary Completion Date | October 25, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer | ||||||
Official Title ICMJE | 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 | ||||||
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. | ||||||
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 ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Hormone-sensitive Prostate Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
1303 | ||||||
Original Estimated Enrollment ICMJE |
1300 | ||||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||||
Actual Primary Completion Date | October 25, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Finland, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Spain, Sweden, Taiwan, United Kingdom, United States | ||||||
Removed Location Countries | Czech Republic, Switzerland | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02799602 | ||||||
Other Study ID Numbers ICMJE | 17777 2015-002590-38 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Bayer | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Bayer | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Orion Corporation, Orion Pharma | ||||||
Investigators ICMJE |
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PRS Account | Bayer | ||||||
Verification Date | September 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |