Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Nonmetastatic Castration-resistant Prostate Cancer (ARAMIS)
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|ClinicalTrials.gov Identifier: NCT02200614|
Recruitment Status : Active, not recruiting
First Posted : July 25, 2014
Results First Posted : October 29, 2019
Last Update Posted : August 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Non-Metastatic Castration-Resistant||Drug: Darolutamide (Nubeqa, BAY1841788) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1509 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||May 26, 2021|
Experimental: Darolutamide (BAY1841788)
Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
Drug: Darolutamide (Nubeqa, BAY1841788)
Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.
Other Name: ODM-201
Placebo Comparator: Placebo
Participants received matching placebo 2 tablets twice daily with food.
Matching placebo 2 tablets twice daily with food.
- Metastasis-Free Survival [ Time Frame: From randomization to the time approximately 385 MFS events were observed (approximately 48 months) ]Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first
- Overall Survival [ Time Frame: From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months) ]Overall Survival (OS) was defined as the time from randomization to death due to any cause.
- Time to Pain Progression [ Time Frame: From randomization until last study treatment (assessed every 4 months) (approximately 48 months) ]Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.
- Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer [ Time Frame: From randomization until last study treatment (assessed every 4 months) (approximately 48 months) ]The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.
- Time to First Symptomatic Skeletal Event (SSE) [ Time Frame: From randomization until last study treatment (assessed every 4 months) (approximately 48 months) ]The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.
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
|Study Director:||Bayer Study Director||Bayer|