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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02799602
Ethics application status
Date submitted
6/06/2016
Date registered
15/06/2016

Titles & IDs
Public title
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-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:
Metastatic Hormone-sensitive Prostate Cancer 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
OS From Date of Randomization Until Death From Any Cause - Number of Events
Timepoint [1] 0 0
From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)
Primary outcome [2] 0 0
OS From Date of Randomization Until Death From Any Cause - Month
Timepoint [2] 0 0
From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)
Secondary outcome [1] 0 0
Number of Participants With TEAEs
Timepoint [1] 0 0
From the first dose of darolutamide or placebo until 30 days after the last dose of darolutamide or placebo administration up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)
Secondary outcome [2] 0 0
Time to Castration-Resistant Prostate Cancer (CRPC) - Number of Events
Timepoint [2] 0 0
From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [3] 0 0
Time to Castration-Resistant Prostate Cancer (CRPC) - Month
Timepoint [3] 0 0
From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [4] 0 0
Time to Pain Progression - Number of Events
Timepoint [4] 0 0
From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [5] 0 0
Time to Pain Progression - Month
Timepoint [5] 0 0
From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [6] 0 0
Symptomatic Skeletal Event Free Survival (SSE-FS) - Number of Events
Timepoint [6] 0 0
From randomization of the first participant to the first occurrence of an SSE event or death from any cause, whichever occurred first up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [7] 0 0
Symptomatic Skeletal Event Free Survival (SSE-FS) - Month
Timepoint [7] 0 0
From randomization of the first participant to the first occurrence of an SSE event or death from any cause, whichever occurred first up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [8] 0 0
Time to First Symptomatic Skeletal Event (SSE) - Number of Events
Timepoint [8] 0 0
From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [9] 0 0
Time to First Symptomatic Skeletal Event (SSE) - Month
Timepoint [9] 0 0
From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [10] 0 0
Time to Initiation of Subsequent Antineoplastic Therapy - Number of Events
Timepoint [10] 0 0
From randomization of the first participant to the initiation of first subsequent systemic antineoplastic therapy up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [11] 0 0
Time to Initiation of Subsequent Antineoplastic Therapy - Month
Timepoint [11] 0 0
From randomization of the first participant to the initiation of first subsequent systemic antineoplastic therapy up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [12] 0 0
Time to Worsening of Disease-Related Physical Symptoms - Number of Events
Timepoint [12] 0 0
From randomization of the first participant to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [13] 0 0
Time to Worsening of Disease-Related Physical Symptoms - Month
Timepoint [13] 0 0
From randomization of the first participant to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [14] 0 0
Time to Initiation of Opioid Use for =7 Consecutive Days - Number of Events
Timepoint [14] 0 0
From randomization of the first participant to the first opioid use for =7 consecutive days up to 25 OCT 2021 cut-off date approximately 59 months
Secondary outcome [15] 0 0
Time to Initiation of Opioid Use for =7 Consecutive Days - Month
Timepoint [15] 0 0
From randomization of the first participant to the first opioid use for =7 consecutive days up to 25 OCT 2021 cut-off date approximately 59 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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/04/2023
Sample size
Target
Accrual to date
Final
1306
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- Randwick
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- Kurralta Park
Recruitment hospital [5] 0 0
- Fitzroy
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
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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Illinois
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Montana
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Nebraska
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Utah
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Virginia
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Washington
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United States of America
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Wisconsin
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Bruxelles - Brussel
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Belgium
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Charleroi
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Belgium
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Gent
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Belgium
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Namur
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Bahia
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Espírito Santo
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Parana
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Rio Grande Do Norte
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Rio Grande Do Sul
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Sao Paulo
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Rio de Janeiro
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Bulgaria
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Gabrovo
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Varna
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Bulgaria
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Vratsa
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Canada
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Alberta
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Ontario
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Quebec
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Anhui
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China
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Hubei
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China
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Jilin
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Liaoning
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Shandong
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Zhejiang
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Beijing
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Chongqing
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Tianjin
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Czechia
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Brno
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Czechia
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Praha 10
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Czechia
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Praha 2
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Czechia
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Praha 5
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Czechia
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Praha 8
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Finland
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Helsinki
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Finland
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Jyväskylä
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Finland
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Kuopio
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Mikkeli
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Finland
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Oulu
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Finland
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Tampere
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Finland
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Turku
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Angers Cedex
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Besancon
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Bordeaux Cedex
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France
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Brest
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France
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Cergy Pontoise
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France
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Clermont-ferrand
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France
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Creteil
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France
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Marseille
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France
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Montpellier Cedex
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France
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Nancy
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France
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Pierre Benite
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France
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Poitiers
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France
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Reims
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France
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Saint Herblain Cedex
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France
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Saint-gregoire
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France
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Strasbourg
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France
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Villejuif Cedex
Country [96] 0 0
Germany
State/province [96] 0 0
Baden-Württemberg
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Germany
State/province [97] 0 0
Bayern
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Germany
State/province [98] 0 0
Mecklenburg-Vorpommern
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Germany
State/province [99] 0 0
Niedersachsen
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Germany
State/province [100] 0 0
Nordrhein-Westfalen
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Germany
State/province [101] 0 0
Sachsen-Anhalt
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Germany
State/province [102] 0 0
Thüringen
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Germany
State/province [103] 0 0
Berlin
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
State/province [106] 0 0
Holon
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Israel
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Israel
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Zefat
Country [111] 0 0
Israel
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Zrifin
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Italy
State/province [112] 0 0
Emilia-Romagna
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Italy
State/province [113] 0 0
Lazio
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Italy
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Lombardia
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Italy
State/province [115] 0 0
Piemonte
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Italy
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Trentino-Alto Adige
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Italy
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Veneto
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Japan
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Aichi
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kagawa
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Japan
State/province [126] 0 0
Kanagawa
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Japan
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Mie
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Japan
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Miyagi
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Japan
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Nara
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tochigi
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Japan
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Tokyo
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Japan
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Tottori
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Japan
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Yamaguchi
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Kumamoto
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Japan
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Miyazaki
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Japan
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Nagasaki
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Japan
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Okayama
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Japan
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Tokushima
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Japan
State/province [143] 0 0
Wakayama
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Korea, Republic of
State/province [144] 0 0
Gwangju Gwang''yeogsi
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Korea, Republic of
State/province [145] 0 0
Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
State/province [147] 0 0
Busan
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Korea, Republic of
State/province [148] 0 0
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Gyeonggi-do
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Korea, Republic of
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Nuevo Leon
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Querétaro
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Hilversum
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Hoofddorp
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Netherlands
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Tilburg
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Lodz
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Lublin
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Rybnik
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Siedlce
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Waliszew
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Poland
State/province [168] 0 0
Warszawa
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Russian Federation
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Barnaul
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Russian Federation
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Chelyabinsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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St. Petersburg
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Spain
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Barcelona
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Spain
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Illes Baleares
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Spain
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Málaga
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Spain
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Cáceres
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Córdoba
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Spain
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Lugo
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Spain
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Madrid
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Valencia
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Göteborg
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Lund
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Stockholm
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Sweden
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Umea
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Sweden
State/province [187] 0 0
Uppsala
Country [188] 0 0
Taiwan
State/province [188] 0 0
Kaohsiung
Country [189] 0 0
Taiwan
State/province [189] 0 0
Taichung
Country [190] 0 0
Taiwan
State/province [190] 0 0
Taipei
Country [191] 0 0
Taiwan
State/province [191] 0 0
Taoyuan
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Essex
Country [193] 0 0
United Kingdom
State/province [193] 0 0
North Yorkshire
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Belfast
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Glasgow
Country [196] 0 0
United Kingdom
State/province [196] 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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.


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/NCT02799602