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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04736199




Registration number
NCT04736199
Ethics application status
Date submitted
29/01/2021
Date registered
3/02/2021

Titles & IDs
Public title
Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
Scientific title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Secondary ID [1] 0 0
2022-502244-12-00
Secondary ID [2] 0 0
21140
Universal Trial Number (UTN)
Trial acronym
ARANOTE
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 - Darolutamide (Nubeqa, BAY1841788)
Treatment: Drugs - Placebo
Other interventions - Androgen deprivation therapy (ADT)

Experimental: Darolutamide+ADT - Participants will receive darolutamide 600 mg (2 tablets of 300 mg) twice daily with food and ADT of investigator's choice as standard therapy

Placebo comparator: Placebo+ADT - Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy


Treatment: Drugs: Darolutamide (Nubeqa, BAY1841788)
Coated tablet, oral administration

Treatment: Drugs: Placebo
Coated tablet matching Darolutamide in appearance, oral administration

Other interventions: Androgen deprivation therapy (ADT)
Luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or orchiectomy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiological progression-free survival (rPFS)
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to 55 months
Secondary outcome [2] 0 0
Time to castration-resistant prostate cancer (CRPC)
Timepoint [2] 0 0
Up to 55 months
Secondary outcome [3] 0 0
Time to initiation of subsequent anti-cancer therapy
Timepoint [3] 0 0
Up to 55 months
Secondary outcome [4] 0 0
Time to PSA progression
Timepoint [4] 0 0
Up to 55 months
Secondary outcome [5] 0 0
PSA undetectable rates (<0.2 ng/mL)
Timepoint [5] 0 0
Up to 55 months
Secondary outcome [6] 0 0
Time to pain progression
Timepoint [6] 0 0
Up to 55 months
Secondary outcome [7] 0 0
Number of participants with adverse events as a measure of safety
Timepoint [7] 0 0
Up to 55 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of prostate
* Metastatic disease
* Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but not earlier than 12 weeks before randomization
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
* 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 except neoadjuvant and /or adjuvant therapy; Second-generation androgen receptor (AR) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational AR inhibitors; Cytochrome P17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as anti-cancer treatment for prostate cancer; Chemotherapy including docetaxel or immunotherapy for prostate cancer; Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization; Radiopharmaceuticals; Any other anti-cancer treatment for prostate cancer, excluding local therapies and ADT.
* Treatment with radiotherapy within 2 weeks before randomization
* Contraindication to iodinated CT and gadolinium chelate MRI intravenous contrast agent(s)
* 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)
* Uncontrolled hypertension as indicated by a resting systolic BP = 160 mmHg or diastolic BP = 100 mmHg despite medical management
* A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
* Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
* 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
23/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/09/2025
Actual
Sample size
Target
Accrual to date
Final
669
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
Northern Cancer Institute - St Leonards
Recruitment hospital [3] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [4] 0 0
Cancer Research South Australia - Adelaide
Recruitment hospital [5] 0 0
Peninsula Oncology Centre - Frankston
Recruitment hospital [6] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2109 - Sydney
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Bahia
Country [2] 0 0
Brazil
State/province [2] 0 0
Goiás
Country [3] 0 0
Brazil
State/province [3] 0 0
Minas Gerais
Country [4] 0 0
Brazil
State/province [4] 0 0
Parana
Country [5] 0 0
Brazil
State/province [5] 0 0
Rio Grande Do Norte
Country [6] 0 0
Brazil
State/province [6] 0 0
Rio Grande Do Sul
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
Brazil
State/province [8] 0 0
Rio de Janeiro
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Chile
State/province [11] 0 0
Araucanía
Country [12] 0 0
Chile
State/province [12] 0 0
Santiago
Country [13] 0 0
Chile
State/province [13] 0 0
Valparaíso
Country [14] 0 0
China
State/province [14] 0 0
Anhui
Country [15] 0 0
China
State/province [15] 0 0
Guangdong
Country [16] 0 0
China
State/province [16] 0 0
Hubei
Country [17] 0 0
China
State/province [17] 0 0
Hunan
Country [18] 0 0
China
State/province [18] 0 0
Jiangsu
Country [19] 0 0
China
State/province [19] 0 0
Jilin
Country [20] 0 0
China
State/province [20] 0 0
Liaoning
Country [21] 0 0
China
State/province [21] 0 0
Shandong
Country [22] 0 0
China
State/province [22] 0 0
Shanxi
Country [23] 0 0
China
State/province [23] 0 0
Sichuan
Country [24] 0 0
China
State/province [24] 0 0
Zhejiang
Country [25] 0 0
China
State/province [25] 0 0
Beijing
Country [26] 0 0
India
State/province [26] 0 0
Andhra Pradesh
Country [27] 0 0
India
State/province [27] 0 0
Gujarat
Country [28] 0 0
India
State/province [28] 0 0
Karnataka
Country [29] 0 0
India
State/province [29] 0 0
Kerala
Country [30] 0 0
India
State/province [30] 0 0
Maharashtra
Country [31] 0 0
India
State/province [31] 0 0
Odisha
Country [32] 0 0
India
State/province [32] 0 0
Orissa
Country [33] 0 0
India
State/province [33] 0 0
Pondicherry
Country [34] 0 0
India
State/province [34] 0 0
Punjab
Country [35] 0 0
India
State/province [35] 0 0
Rajasthan
Country [36] 0 0
India
State/province [36] 0 0
Tamil Nadu
Country [37] 0 0
India
State/province [37] 0 0
Chandigarh
Country [38] 0 0
India
State/province [38] 0 0
Kolkata
Country [39] 0 0
India
State/province [39] 0 0
Nashik
Country [40] 0 0
India
State/province [40] 0 0
New Delhi
Country [41] 0 0
Latvia
State/province [41] 0 0
Daugavpils
Country [42] 0 0
Latvia
State/province [42] 0 0
Riga
Country [43] 0 0
Latvia
State/province [43] 0 0
Valmiera
Country [44] 0 0
Lithuania
State/province [44] 0 0
Kaunas
Country [45] 0 0
Lithuania
State/province [45] 0 0
Klaipeda
Country [46] 0 0
Lithuania
State/province [46] 0 0
Vilnius
Country [47] 0 0
New Zealand
State/province [47] 0 0
Christchurch
Country [48] 0 0
New Zealand
State/province [48] 0 0
Hamilton
Country [49] 0 0
New Zealand
State/province [49] 0 0
Tauranga
Country [50] 0 0
Peru
State/province [50] 0 0
Lima
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Arkhangelsk
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Chelyabinsk
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Ivanovo
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Kazan
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Moscow
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Nizhny Novgorod
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Novosibirsk
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Omsk
Country [59] 0 0
Russian Federation
State/province [59] 0 0
St. Petersburg
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Tyumen
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Ufa
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Vologda
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Yekaterinburg
Country [64] 0 0
South Africa
State/province [64] 0 0
Eastern Cape
Country [65] 0 0
South Africa
State/province [65] 0 0
Gauteng
Country [66] 0 0
South Africa
State/province [66] 0 0
Cape Town
Country [67] 0 0
Spain
State/province [67] 0 0
Barcelona
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid
Country [69] 0 0
Spain
State/province [69] 0 0
Cáceres
Country [70] 0 0
Spain
State/province [70] 0 0
Málaga
Country [71] 0 0
Spain
State/province [71] 0 0
Sevilla
Country [72] 0 0
Taiwan
State/province [72] 0 0
Kaohsiung
Country [73] 0 0
Taiwan
State/province [73] 0 0
Changhua
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taichung
Country [75] 0 0
Taiwan
State/province [75] 0 0
Tainan
Country [76] 0 0
Taiwan
State/province [76] 0 0
Taipei
Country [77] 0 0
Ukraine
State/province [77] 0 0
Cherkasy
Country [78] 0 0
Ukraine
State/province [78] 0 0
Dnipro
Country [79] 0 0
Ukraine
State/province [79] 0 0
Kyiv

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
Address 0 0
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 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04736199