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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
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
Secondary ID [1] 0 0
2013-003820-36
Secondary ID [2] 0 0
17712
Universal Trial Number (UTN)
Trial acronym
ARAMIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer Non-Metastatic 0 0
Castration-Resistant 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Metastasis-Free Survival
Timepoint [1] 0 0
From randomization to the time approximately 385 MFS events were observed (approximately 48 months)
Secondary outcome [1] 0 0
Overall Survival - Primary Analysis
Timepoint [1] 0 0
From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)
Secondary outcome [2] 0 0
Time to Pain Progression - Primary Analysis
Timepoint [2] 0 0
From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
Secondary outcome [3] 0 0
Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis
Timepoint [3] 0 0
From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
Secondary outcome [4] 0 0
Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis
Timepoint [4] 0 0
From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
Secondary outcome [5] 0 0
Overall Survival - Final Analysis
Timepoint [5] 0 0
From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months)
Secondary outcome [6] 0 0
Time to Pain Progression - Final Analysis
Timepoint [6] 0 0
From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
Secondary outcome [7] 0 0
Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis
Timepoint [7] 0 0
From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months)
Secondary outcome [8] 0 0
Time to First Symptomatic Skeletal Event (SSE) - Final Analysis
Timepoint [8] 0 0
From randomization until occurrence of first SSE event (approximately 59 months)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/06/2021
Sample size
Target
Accrual to date
Final
1509
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Randwick
Recruitment hospital [2] 0 0
- St Leonards
Recruitment hospital [3] 0 0
- Douglas
Recruitment hospital [4] 0 0
- South Brisbane
Recruitment hospital [5] 0 0
- Kurralta Park
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment outside Australia
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Nizhny Novgorod
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Orenburg
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Rostov-on-Don
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Saratov
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Tyumen
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Ufa
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Vladimir
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Serbia
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Belgrade
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Serbia
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Nis
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Slovakia
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Bratislava
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Slovakia
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Martin
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Trencin
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South Africa
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Orion Corporation, Orion Pharma
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02200614
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02200614