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Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Nonmetastatic 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. Identifier: NCT02200614
Recruitment Status : Active, not recruiting
First Posted : July 25, 2014
Last Update Posted : June 21, 2019
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):

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 (BAY1841788) Drug: Placebo Phase 3

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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
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Darolutamide (BAY1841788)
Metastasis-free survival (MFS) in patients with high-risk non-metastatic castration-resistant prostate cancer
Drug: Darolutamide (BAY1841788)
Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.

Placebo Comparator: Placebo
Metastasis-free survival (MFS) in patients with high-risk non-metastatic castration-resistant prostate cancer
Drug: Placebo
Matching placebo 2 tablets twice daily with food.

Primary Outcome Measures :
  1. Metastasis-Free Survival [ Time Frame: Up to 72 months ]
    Time from randomisation to evidence of metastasis or death from any cause, whichever occurs first

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 72 months ]
    Date of death and primary cause of death will be recorded

  2. Time to first symptomatic skeletal event (SSE) [ Time Frame: Up to 72 months ]
    Date of first SSE will be recorded

  3. Time to initiation of first cytotoxic chemotherapy for prostate cancer [ Time Frame: Up to 72 months ]
    Name and start date of cytotoxic chemotherapy treatment will be recorded

  4. Time to pain progression [ Time Frame: Up to 72 months ]
    Date of pain progression will be recorded

  5. Safety and tolerability of ODM-201 [ Time Frame: Up to 72 months ]
    Summaries of AEs, the frequency of discontinuation of study treatment due to AEs, laboratory evaluations, vital signs, ECGs and physical examination.

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

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 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.

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): NCT02200614

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Sponsors and Collaborators
Orion Corporation, Orion Pharma
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT02200614     History of Changes
Other Study ID Numbers: 17712
2013-003820-36 ( EudraCT Number )
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019

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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
Genital Diseases, Male
Prostatic Diseases