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Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic 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 : Completed
First Posted : July 25, 2014
Results First Posted : October 29, 2019
Last Update Posted : June 28, 2022
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Bayer

Study Description
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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 (Nubeqa, BAY1841788) Drug: Placebo Phase 3

Study Design
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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
Actual Study Completion Date : June 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Placebo
Matching placebo 2 tablets twice daily with food.


Outcome Measures
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Primary Outcome Measures :
  1. 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 (cut-off date 15 Nov 2019)


Secondary Outcome Measures :
  1. Overall Survival - Primary Analysis [ 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.

  2. Time to Pain Progression - Primary Analysis [ 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.

  3. Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis [ 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.

  4. Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis [ 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.

  5. Overall Survival - Final Analysis [ Time Frame: From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months) ]
    Overall Survival (OS) was defined as the time from randomization to death due to any cause. The final analysis was done at the time of the data cut-off (15 NOV 2019).

  6. Time to Pain Progression - Final Analysis [ Time Frame: From randomization until last study treatment (assessed every 4 months) (approximately 48 months) ]
    For time to pain progression, the analysis performed using the primary completion cut-off data (03 SEP 2018) was considered final and no new analysis was performed for time to pain progression.

  7. Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis [ Time Frame: From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months) ]
    The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle. The final analysis was done at the time of the data cut-off (15 NOV 2019).

  8. Time to First Symptomatic Skeletal Event (SSE) - Final Analysis [ Time Frame: From randomization until occurrence of first SSE event (approximately 59 months) ]
    The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE. The final analysis was done at the time of the data cut-off (15 NOV 2019).


Eligibility Criteria
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Information from the National Library of Medicine

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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 (PSA) 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.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Bayer
Orion Corporation, Orion Pharma
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] July 6, 2019
Statistical Analysis Plan  [PDF] March 12, 2021

More Information
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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    
Other Study ID Numbers: 17712
2013-003820-36 ( EudraCT Number )
First Posted: July 25, 2014    Key Record Dates
Results First Posted: October 29, 2019
Last Update Posted: June 28, 2022
Last Verified: June 2022

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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
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases