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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02200614
Registration number
NCT02200614
Ethics application status
Date submitted
22/07/2014
Date registered
25/07/2014
Date last updated
28/06/2022
Titles & IDs
Public title
Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
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Scientific 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
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Secondary ID [1]
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0
2013-003820-36
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Secondary ID [2]
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17712
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Universal Trial Number (UTN)
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Trial acronym
ARAMIS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer Non-Metastatic
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Castration-Resistant
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Darolutamide (Nubeqa, BAY1841788)
Treatment: Drugs - Placebo
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.
Placebo comparator: Placebo - Participants received matching placebo 2 tablets twice daily with food.
Treatment: Drugs: Darolutamide (Nubeqa, BAY1841788)
Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.
Treatment: Drugs: Placebo
Matching placebo 2 tablets twice daily with food.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Metastasis-Free Survival
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Assessment method [1]
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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)
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Timepoint [1]
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From randomization to the time approximately 385 MFS events were observed (approximately 48 months)
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Secondary outcome [1]
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Overall Survival - Primary Analysis
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Assessment method [1]
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Overall Survival (OS) was defined as the time from randomization to death due to any cause.
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Timepoint [1]
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From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)
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Secondary outcome [2]
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Time to Pain Progression - Primary Analysis
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Assessment method [2]
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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.
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Timepoint [2]
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From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
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Secondary outcome [3]
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Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis
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Assessment method [3]
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The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.
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Timepoint [3]
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From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
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Secondary outcome [4]
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Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis
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Assessment method [4]
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The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.
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Timepoint [4]
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From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
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Secondary outcome [5]
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Overall Survival - Final Analysis
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Assessment method [5]
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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).
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Timepoint [5]
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From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months)
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Secondary outcome [6]
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Time to Pain Progression - Final Analysis
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Assessment method [6]
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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.
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Timepoint [6]
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From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
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Secondary outcome [7]
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Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis
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Assessment method [7]
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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).
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Timepoint [7]
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From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months)
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Secondary outcome [8]
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Time to First Symptomatic Skeletal Event (SSE) - Final Analysis
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Assessment method [8]
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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).
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Timepoint [8]
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From randomization until occurrence of first SSE event (approximately 59 months)
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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-a 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/09/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/06/2021
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Sample size
Target
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Accrual to date
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Final
1509
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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- Randwick
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- St Leonards
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- Douglas
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- South Brisbane
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Recruitment hospital [5]
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- Kurralta Park
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Recruitment hospital [6]
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- Fitzroy
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Recruitment postcode(s) [1]
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2031 - Randwick
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2065 - St Leonards
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4814 - Douglas
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4101 - South Brisbane
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5037 - Kurralta Park
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Recruitment postcode(s) [6]
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3065 - Fitzroy
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bayer
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Address
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Other collaborator category [1]
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Orion Corporation, Orion Pharma
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02200614
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Trial related presentations / publications
Chowdhury S, Oudard S, Uemura H, Joniau S, Dearden L, Capone C, Van Sanden S, Diels J, Hadaschik BA. Apalutamide Compared with Darolutamide for the Treatment of Non-metastatic Castration-Resistant Prostate Cancer: Efficacy and Tolerability in a Matching-Adjusted Indirect Comparison. Adv Ther. 2022 Jan;39(1):518-531. doi: 10.1007/s12325-021-01885-6. Epub 2021 Nov 19. Fizazi K, Blue I, Nowak JT. Darolutamide and survival in nonmetastatic, castration-resistant prostate cancer: a patient perspective of the ARAMIS trial. Future Oncol. 2021 May;17(14):1699-1707. doi: 10.2217/fon-2020-1291. Epub 2021 Feb 8. Erratum In: Future Oncol. 2022 Jan;18(2):275. doi: 10.2217/fon-2020-1291c1. Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Le Berre MA, Petrenciuc O, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide. N Engl J Med. 2020 Sep 10;383(11):1040-1049. doi: 10.1056/NEJMoa2001342. Shore N, Zurth C, Fricke R, Gieschen H, Graudenz K, Koskinen M, Ploeger B, Moss J, Prien O, Borghesi G, Petrenciuc O, Tammela TL, Kuss I, Verholen F, Smith MR, Fizazi K. Evaluation of Clinically Relevant Drug-Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial. Target Oncol. 2019 Oct;14(5):527-539. doi: 10.1007/s11523-019-00674-0. Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Kappeler C, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019 Mar 28;380(13):1235-1246. doi: 10.1056/NEJMoa1815671. Epub 2019 Feb 14. Erratum In: N Engl J Med. 2022 Sep 1;387(9):860. doi: 10.1056/NEJMx220007.
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Public notes
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Contacts
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Bayer Study Director
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/14/NCT02200614/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/14/NCT02200614/SAP_003.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02200614
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