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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02799602




Registration number
NCT02799602
Ethics application status
Date submitted
6/06/2016
Date registered
15/06/2016
Date last updated
27/05/2021

Titles & IDs
Public title
ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
Scientific title
A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer
Secondary ID [1] 0 0
2015-002590-38
Secondary ID [2] 0 0
17777
Universal Trial Number (UTN)
Trial acronym
ARASENS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAY1841788 / darolutamide (ODM-201)
Treatment: Drugs - Standard ADT (androgen deprivation therapy)
Treatment: Drugs - Docetaxel
Treatment: Drugs - Placebo

Experimental: BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel - Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel

Placebo Comparator: Placebo + standard ADT + Docetaxel - Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel


Treatment: Drugs: BAY1841788 / darolutamide (ODM-201)
600mg (2 tablets of 300 mg) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total a daily dose of 1200 mg in addition to standard ADT (luteinizing hormone releasing hormone (LHRH) agonist/antagonist or orchiectomy) and 6 cycles of docetaxel

Treatment: Drugs: Standard ADT (androgen deprivation therapy)
As prescribed by the treating physician.

Treatment: Drugs: Docetaxel
As prescribed by the treating physician.

Treatment: Drugs: Placebo
Placebo matching darolutamide (ODM-201) tablets in appearance, bid orally with food, in addition to standard ADT (luteinizing hormone releasing hormone [LHRH] agonist/antagonist or orchiectomy) and 6 cycles of docetaxel.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival - From date of randomization until death from any cause, during treatment and during active and long term follow-up
Timepoint [1] 0 0
approximately 70 months
Secondary outcome [1] 0 0
Time to castration resistant prostate cancer - Approximately every 12 weeks (according to standards of care) up to the time of PSA progression by soft tissue/visceral lesions or progression by bone lesions, whatever come first.
Timepoint [1] 0 0
approximately 70 months
Secondary outcome [2] 0 0
Time to initiation of subsequent antineoplastic therapy - Every 12 weeks up to the date of first subsequent antineoplastic therapy for prostate cancer.
Timepoint [2] 0 0
approximately 70 months
Secondary outcome [3] 0 0
Symptomatic skeletal event free survival (SSE-FS) - Every 12 weeks up to the first occurrence of SSE or death from any cause, whatever comes first SSE is defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first.
Timepoint [3] 0 0
approximately 70 months
Secondary outcome [4] 0 0
Time to first symptomatic skeletal event (SSE) - Every 12 weeks up to the first occurrence of SSE. SSE is defined as EBRT to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first.
Timepoint [4] 0 0
approximately 70 months
Secondary outcome [5] 0 0
Time to initiation of opioid use - Every 12 weeks up to the opiod use.
Timepoint [5] 0 0
approximately 70 months
Secondary outcome [6] 0 0
Time to pain progression - Every 12 weeks up to the first date a subject experiences a pain progression. Pain to be assessed with a patient reported questionaire.
Timepoint [6] 0 0
approximately 70 months
Secondary outcome [7] 0 0
Time to worsening of physical symptoms of disease - Every 12 weeks up to the first date a subject experiences an increase in physical symptoms.
Physical symptoms of disease to be assessed with a patient reported questionaire.
Timepoint [7] 0 0
approximately 70 months
Secondary outcome [8] 0 0
Number of participants with adverse events as a measure of safety and tolerability
Timepoint [8] 0 0
approximately 70 months

Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed adenocarcinoma of prostate.

- Metastatic disease

- Candidates for ADT and docetaxel.

- Started ADT with or without first generation anti androgen, but no longer than 12
weeks before randomization

- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate bone marrow, liver and renal function
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor
(AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), other
investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or
oral ketoconazole as antineoplastic treatment for prostate cancer; chemotherapy or
immunotherapy for prostate cancer prior to randomization.

- Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.

- Had any of the following within 6 months before randomization: stroke, myocardial
infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
congestive heart failure (New York Heart Association Class III or IV)

- Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of
skin or superficial bladder cancer that has not spread behind the connective tissue
layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which
treatment has been completed 5 years before randomization and from which the subject
has been disease-free

- Gastrointestinal disorder or procedure which is expected to interfere significantly
with absorption of study treatment.

- Inability to swallow oral medications

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,SA,VIC
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- Randwick
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- Sydney
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- Adelaide
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- Melbourne
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- Kurralta Park
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3065 - Melbourne
Recruitment postcode(s) [5] 0 0
5037 - Kurralta Park
Recruitment outside Australia
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Taoyuan
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United Kingdom
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Essex
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United Kingdom
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North Yorkshire
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Belfast
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Glasgow
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United Kingdom
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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
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide
(ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in
patients with metastatic hormone sensitive prostate cancer.
Trial website
https://clinicaltrials.gov/show/NCT02799602
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