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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02200614




Registration number
NCT02200614
Ethics application status
Date submitted
22/07/2014
Date registered
25/07/2014
Date last updated
17/06/2020

Titles & IDs
Public title
Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Nonmetastatic 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 - Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first
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 - Overall Survival (OS) was defined as the time from randomization to death due to any cause.
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 - 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.
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 - The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.
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) - The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.
Timepoint [4] 0 0
From randomization until last study treatment (assessed every 4 months) (approximately 48 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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Randwick
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- St Leonards
Recruitment hospital [3] 0 0
- Douglas
Recruitment hospital [4] 0 0
- South Brisbane
Recruitment hospital [5] 0 0
- Fitzroy
Recruitment hospital [6] 0 0
- Kurralta Park
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
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment outside Australia
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Ishikawa
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Miyagi
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Nara
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Oita
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Osaka
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Saitama
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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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Tyumen
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Ufa
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Russian Federation
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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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Slovakia
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Trencin
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South Africa
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Eastern Cape
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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/show/NCT02200614
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

Summary results
Other publications