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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
Date last updated
16/04/2024

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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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Illinois
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Montana
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United States of America
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Nebraska
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New Hampshire
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
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State/province [16] 0 0
New Mexico
Country [17] 0 0
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State/province [17] 0 0
New York
Country [18] 0 0
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State/province [18] 0 0
North Carolina
Country [19] 0 0
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State/province [19] 0 0
Ohio
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Oklahoma
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Pennsylvania
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United States of America
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South Carolina
Country [23] 0 0
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Texas
Country [24] 0 0
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State/province [24] 0 0
Utah
Country [25] 0 0
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State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Belgium
State/province [28] 0 0
Antwerpen
Country [29] 0 0
Belgium
State/province [29] 0 0
Brussels
Country [30] 0 0
Belgium
State/province [30] 0 0
Bruxelles - Brussel
Country [31] 0 0
Belgium
State/province [31] 0 0
Charleroi
Country [32] 0 0
Belgium
State/province [32] 0 0
Gent
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Belgium
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Namur
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Brazil
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Bahia
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Brazil
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Espírito Santo
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Brazil
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Parana
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Brazil
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Rio Grande Do Norte
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Brazil
State/province [38] 0 0
Rio Grande Do Sul
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Brazil
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Sao Paulo
Country [40] 0 0
Brazil
State/province [40] 0 0
Rio de Janeiro
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Gabrovo
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Pleven
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Sofia
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Varna
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Vratsa
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
Ontario
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Canada
State/province [48] 0 0
Quebec
Country [49] 0 0
China
State/province [49] 0 0
Anhui
Country [50] 0 0
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State/province [50] 0 0
Fujian
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State/province [51] 0 0
Guangdong
Country [52] 0 0
China
State/province [52] 0 0
Hebei
Country [53] 0 0
China
State/province [53] 0 0
Henan
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China
State/province [54] 0 0
Hubei
Country [55] 0 0
China
State/province [55] 0 0
Hunan
Country [56] 0 0
China
State/province [56] 0 0
Jiangsu
Country [57] 0 0
China
State/province [57] 0 0
Jiangxi
Country [58] 0 0
China
State/province [58] 0 0
Jilin
Country [59] 0 0
China
State/province [59] 0 0
Liaoning
Country [60] 0 0
China
State/province [60] 0 0
Shaanxi
Country [61] 0 0
China
State/province [61] 0 0
Shandong
Country [62] 0 0
China
State/province [62] 0 0
Zhejiang
Country [63] 0 0
China
State/province [63] 0 0
Beijing
Country [64] 0 0
China
State/province [64] 0 0
Chongqing
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China
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Shanghai
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China
State/province [66] 0 0
Tianjin
Country [67] 0 0
Czechia
State/province [67] 0 0
Brno
Country [68] 0 0
Czechia
State/province [68] 0 0
Praha 10
Country [69] 0 0
Czechia
State/province [69] 0 0
Praha 2
Country [70] 0 0
Czechia
State/province [70] 0 0
Praha 5
Country [71] 0 0
Czechia
State/province [71] 0 0
Praha 8
Country [72] 0 0
Finland
State/province [72] 0 0
Helsinki
Country [73] 0 0
Finland
State/province [73] 0 0
Jyväskylä
Country [74] 0 0
Finland
State/province [74] 0 0
Kuopio
Country [75] 0 0
Finland
State/province [75] 0 0
Mikkeli
Country [76] 0 0
Finland
State/province [76] 0 0
Oulu
Country [77] 0 0
Finland
State/province [77] 0 0
Tampere
Country [78] 0 0
Finland
State/province [78] 0 0
Turku
Country [79] 0 0
France
State/province [79] 0 0
Angers Cedex
Country [80] 0 0
France
State/province [80] 0 0
Besancon
Country [81] 0 0
France
State/province [81] 0 0
Bordeaux Cedex
Country [82] 0 0
France
State/province [82] 0 0
Brest
Country [83] 0 0
France
State/province [83] 0 0
Cergy Pontoise
Country [84] 0 0
France
State/province [84] 0 0
Clermont-ferrand
Country [85] 0 0
France
State/province [85] 0 0
Creteil
Country [86] 0 0
France
State/province [86] 0 0
Marseille
Country [87] 0 0
France
State/province [87] 0 0
Montpellier Cedex
Country [88] 0 0
France
State/province [88] 0 0
Nancy
Country [89] 0 0
France
State/province [89] 0 0
Pierre Benite
Country [90] 0 0
France
State/province [90] 0 0
Poitiers
Country [91] 0 0
France
State/province [91] 0 0
Reims
Country [92] 0 0
France
State/province [92] 0 0
Saint Herblain Cedex
Country [93] 0 0
France
State/province [93] 0 0
Saint-gregoire
Country [94] 0 0
France
State/province [94] 0 0
Strasbourg
Country [95] 0 0
France
State/province [95] 0 0
Villejuif Cedex
Country [96] 0 0
Germany
State/province [96] 0 0
Baden-Württemberg
Country [97] 0 0
Germany
State/province [97] 0 0
Bayern
Country [98] 0 0
Germany
State/province [98] 0 0
Mecklenburg-Vorpommern
Country [99] 0 0
Germany
State/province [99] 0 0
Niedersachsen
Country [100] 0 0
Germany
State/province [100] 0 0
Nordrhein-Westfalen
Country [101] 0 0
Germany
State/province [101] 0 0
Sachsen-Anhalt
Country [102] 0 0
Germany
State/province [102] 0 0
Thüringen
Country [103] 0 0
Germany
State/province [103] 0 0
Berlin
Country [104] 0 0
Israel
State/province [104] 0 0
Beer Sheva
Country [105] 0 0
Israel
State/province [105] 0 0
Haifa
Country [106] 0 0
Israel
State/province [106] 0 0
Holon
Country [107] 0 0
Israel
State/province [107] 0 0
Jerusalem
Country [108] 0 0
Israel
State/province [108] 0 0
Petach Tikva
Country [109] 0 0
Israel
State/province [109] 0 0
Tel Aviv
Country [110] 0 0
Israel
State/province [110] 0 0
Zefat
Country [111] 0 0
Israel
State/province [111] 0 0
Zrifin
Country [112] 0 0
Italy
State/province [112] 0 0
Emilia-Romagna
Country [113] 0 0
Italy
State/province [113] 0 0
Lazio
Country [114] 0 0
Italy
State/province [114] 0 0
Lombardia
Country [115] 0 0
Italy
State/province [115] 0 0
Piemonte
Country [116] 0 0
Italy
State/province [116] 0 0
Trentino-Alto Adige
Country [117] 0 0
Italy
State/province [117] 0 0
Veneto
Country [118] 0 0
Japan
State/province [118] 0 0
Aichi
Country [119] 0 0
Japan
State/province [119] 0 0
Aomori
Country [120] 0 0
Japan
State/province [120] 0 0
Chiba
Country [121] 0 0
Japan
State/province [121] 0 0
Ehime
Country [122] 0 0
Japan
State/province [122] 0 0
Hokkaido
Country [123] 0 0
Japan
State/province [123] 0 0
Hyogo
Country [124] 0 0
Japan
State/province [124] 0 0
Ishikawa
Country [125] 0 0
Japan
State/province [125] 0 0
Kagawa
Country [126] 0 0
Japan
State/province [126] 0 0
Kanagawa
Country [127] 0 0
Japan
State/province [127] 0 0
Mie
Country [128] 0 0
Japan
State/province [128] 0 0
Miyagi
Country [129] 0 0
Japan
State/province [129] 0 0
Nara
Country [130] 0 0
Japan
State/province [130] 0 0
Osaka
Country [131] 0 0
Japan
State/province [131] 0 0
Shizuoka
Country [132] 0 0
Japan
State/province [132] 0 0
Tochigi
Country [133] 0 0
Japan
State/province [133] 0 0
Tokyo
Country [134] 0 0
Japan
State/province [134] 0 0
Tottori
Country [135] 0 0
Japan
State/province [135] 0 0
Yamaguchi
Country [136] 0 0
Japan
State/province [136] 0 0
Fukuoka
Country [137] 0 0
Japan
State/province [137] 0 0
Gifu
Country [138] 0 0
Japan
State/province [138] 0 0
Kumamoto
Country [139] 0 0
Japan
State/province [139] 0 0
Miyazaki
Country [140] 0 0
Japan
State/province [140] 0 0
Nagasaki
Country [141] 0 0
Japan
State/province [141] 0 0
Okayama
Country [142] 0 0
Japan
State/province [142] 0 0
Tokushima
Country [143] 0 0
Japan
State/province [143] 0 0
Wakayama
Country [144] 0 0
Korea, Republic of
State/province [144] 0 0
Gwangju Gwang''yeogsi
Country [145] 0 0
Korea, Republic of
State/province [145] 0 0
Gyeonggido
Country [146] 0 0
Korea, Republic of
State/province [146] 0 0
Seoul Teugbyeolsi
Country [147] 0 0
Korea, Republic of
State/province [147] 0 0
Busan
Country [148] 0 0
Korea, Republic of
State/province [148] 0 0
Daegu
Country [149] 0 0
Korea, Republic of
State/province [149] 0 0
Gyeonggi-do
Country [150] 0 0
Korea, Republic of
State/province [150] 0 0
Seoul
Country [151] 0 0
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State/province [151] 0 0
Distrito Federal
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Mexico
State/province [152] 0 0
Morelos
Country [153] 0 0
Mexico
State/province [153] 0 0
Nuevo Leon
Country [154] 0 0
Mexico
State/province [154] 0 0
Querétaro
Country [155] 0 0
Mexico
State/province [155] 0 0
Sinaloa
Country [156] 0 0
Netherlands
State/province [156] 0 0
Amsterdam
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Netherlands
State/province [157] 0 0
Den Haag
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Netherlands
State/province [158] 0 0
Dordrecht
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Netherlands
State/province [159] 0 0
Geleen
Country [160] 0 0
Netherlands
State/province [160] 0 0
Hilversum
Country [161] 0 0
Netherlands
State/province [161] 0 0
Hoofddorp
Country [162] 0 0
Netherlands
State/province [162] 0 0
Tilburg
Country [163] 0 0
Poland
State/province [163] 0 0
Lodz
Country [164] 0 0
Poland
State/province [164] 0 0
Lublin
Country [165] 0 0
Poland
State/province [165] 0 0
Rybnik
Country [166] 0 0
Poland
State/province [166] 0 0
Siedlce
Country [167] 0 0
Poland
State/province [167] 0 0
Waliszew
Country [168] 0 0
Poland
State/province [168] 0 0
Warszawa
Country [169] 0 0
Russian Federation
State/province [169] 0 0
Barnaul
Country [170] 0 0
Russian Federation
State/province [170] 0 0
Chelyabinsk
Country [171] 0 0
Russian Federation
State/province [171] 0 0
Moscow
Country [172] 0 0
Russian Federation
State/province [172] 0 0
Novosibirsk
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Russian Federation
State/province [173] 0 0
Omsk
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Russian Federation
State/province [174] 0 0
St. Petersburg
Country [175] 0 0
Spain
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Barcelona
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Spain
State/province [176] 0 0
Illes Baleares
Country [177] 0 0
Spain
State/province [177] 0 0
Málaga
Country [178] 0 0
Spain
State/province [178] 0 0
Cáceres
Country [179] 0 0
Spain
State/province [179] 0 0
Córdoba
Country [180] 0 0
Spain
State/province [180] 0 0
Lugo
Country [181] 0 0
Spain
State/province [181] 0 0
Madrid
Country [182] 0 0
Spain
State/province [182] 0 0
Valencia
Country [183] 0 0
Sweden
State/province [183] 0 0
Göteborg
Country [184] 0 0
Sweden
State/province [184] 0 0
Lund
Country [185] 0 0
Sweden
State/province [185] 0 0
Stockholm
Country [186] 0 0
Sweden
State/province [186] 0 0
Umea
Country [187] 0 0
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
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/study/NCT02799602
Trial related presentations / publications
Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford D, Manarite J, Muslin D, Farrington T, Tombal B. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: a patient and caregiver perspective and plain language summary of the ARASENS trial. Future Oncol. 2022 Jul;18(21):2585-2597. doi: 10.2217/fon-2022-0433. Epub 2022 Jun 3.
Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.
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/NCT02799602