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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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Krasnoyarsk
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Moscow
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Nizhny Novgorod
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Orenburg
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Pyatigorsk
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Rostov-on-Don
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Saratov
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St. Petersburg
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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
Country [208] 0 0
Slovakia
State/province [208] 0 0
Trencin
Country [209] 0 0
South Africa
State/province [209] 0 0
Eastern Cape
Country [210] 0 0
South Africa
State/province [210] 0 0
Gauteng
Country [211] 0 0
South Africa
State/province [211] 0 0
Western Cape
Country [212] 0 0
South Africa
State/province [212] 0 0
Cape Town
Country [213] 0 0
Spain
State/province [213] 0 0
Alicante
Country [214] 0 0
Spain
State/province [214] 0 0
Andalucía
Country [215] 0 0
Spain
State/province [215] 0 0
Barcelona
Country [216] 0 0
Spain
State/province [216] 0 0
Cádiz
Country [217] 0 0
Spain
State/province [217] 0 0
Illes Baleares
Country [218] 0 0
Spain
State/province [218] 0 0
Madrid
Country [219] 0 0
Spain
State/province [219] 0 0
Vizcaya
Country [220] 0 0
Spain
State/province [220] 0 0
Córdoba
Country [221] 0 0
Spain
State/province [221] 0 0
Granada
Country [222] 0 0
Spain
State/province [222] 0 0
Lugo
Country [223] 0 0
Spain
State/province [223] 0 0
Málaga
Country [224] 0 0
Spain
State/province [224] 0 0
Salamanca
Country [225] 0 0
Spain
State/province [225] 0 0
Sevilla
Country [226] 0 0
Spain
State/province [226] 0 0
Valencia
Country [227] 0 0
Sweden
State/province [227] 0 0
Göteborg
Country [228] 0 0
Sweden
State/province [228] 0 0
Stockholm
Country [229] 0 0
Sweden
State/province [229] 0 0
Uppsala
Country [230] 0 0
Sweden
State/province [230] 0 0
Örebro
Country [231] 0 0
Taiwan
State/province [231] 0 0
Kaohsiung City ,
Country [232] 0 0
Taiwan
State/province [232] 0 0
Kaoshiung
Country [233] 0 0
Taiwan
State/province [233] 0 0
Taichung
Country [234] 0 0
Taiwan
State/province [234] 0 0
Taipei
Country [235] 0 0
Taiwan
State/province [235] 0 0
Taoyuan
Country [236] 0 0
Turkey
State/province [236] 0 0
Ankara
Country [237] 0 0
Turkey
State/province [237] 0 0
Istanbul
Country [238] 0 0
Turkey
State/province [238] 0 0
Izmir
Country [239] 0 0
Turkey
State/province [239] 0 0
Manisa
Country [240] 0 0
Turkey
State/province [240] 0 0
Sivas
Country [241] 0 0
Ukraine
State/province [241] 0 0
Chernivtsi
Country [242] 0 0
Ukraine
State/province [242] 0 0
Dnipro
Country [243] 0 0
Ukraine
State/province [243] 0 0
Kharkiv
Country [244] 0 0
Ukraine
State/province [244] 0 0
Kryvyi Rih
Country [245] 0 0
Ukraine
State/province [245] 0 0
Kyiv
Country [246] 0 0
Ukraine
State/province [246] 0 0
Uzhgorod
Country [247] 0 0
Ukraine
State/province [247] 0 0
Zaporozhye
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Berkshire
Country [249] 0 0
United Kingdom
State/province [249] 0 0
Carmarthenshire
Country [250] 0 0
United Kingdom
State/province [250] 0 0
Essex
Country [251] 0 0
United Kingdom
State/province [251] 0 0
Hertfordshire
Country [252] 0 0
United Kingdom
State/province [252] 0 0
Kent
Country [253] 0 0
United Kingdom
State/province [253] 0 0
Lancashire
Country [254] 0 0
United Kingdom
State/province [254] 0 0
Merseyside
Country [255] 0 0
United Kingdom
State/province [255] 0 0
North East Lincolnshire
Country [256] 0 0
United Kingdom
State/province [256] 0 0
Somerset
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Staffordshire
Country [258] 0 0
United Kingdom
State/province [258] 0 0
West Midlands
Country [259] 0 0
United Kingdom
State/province [259] 0 0
West Yorkshire
Country [260] 0 0
United Kingdom
State/province [260] 0 0
Cardiff
Country [261] 0 0
United Kingdom
State/province [261] 0 0
Glasgow
Country [262] 0 0
United Kingdom
State/province [262] 0 0
London

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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02200614