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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
Date last updated
14/06/2024
Titles & IDs
Public title
Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
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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)
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Secondary ID [1]
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2022-502244-12-00
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Secondary ID [2]
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21140
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Universal Trial Number (UTN)
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Trial acronym
ARANOTE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
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Condition category
Condition code
Cancer
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Prostate
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Inflammatory and Immune System
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0
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Allergies
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Radiological progression-free survival (rPFS)
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Assessment method [1]
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Time from the date of randomization to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first.
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Timepoint [1]
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36 months
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Secondary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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Time from the date of randomization to the date of death from any cause.
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Timepoint [1]
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Up to 55 months
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Secondary outcome [2]
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Time to castration-resistant prostate cancer (CRPC)
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Assessment method [2]
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Time from the date of randomization to the date of first castration resistant event (radiological progression, PSA progression or symptomatic skeletal events, whichever occurs first).
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Timepoint [2]
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Up to 55 months
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Secondary outcome [3]
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Time to initiation of subsequent anti-cancer therapy
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Assessment method [3]
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Time from the date of randomization to initiation of first subsequent anti-cancer therapy for prostate cancer.
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Timepoint [3]
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Up to 55 months
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Secondary outcome [4]
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Time to PSA progression
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Assessment method [4]
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Time from the date of randomization to the date of first prostate-specific antigen (PSA) progression. PSA progression is defined as a =25% increase above the nadir (lowest Screening or baseline) value, which is confirmed by a second value 3 or more weeks later, and an increase in absolute value of = 2 ng/mL above nadir, at least 12 weeks from baseline.
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Timepoint [4]
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Up to 55 months
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Secondary outcome [5]
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PSA undetectable rates (<0.2 ng/mL)
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Assessment method [5]
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The percentage of participants with detectable PSA values (=0.2 ng/mL) at baseline which become undetectable (\<0.2 ng/mL) during the study treatment.
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Timepoint [5]
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Up to 55 months
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Secondary outcome [6]
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Time to pain progression
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Assessment method [6]
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Time from the date of randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline. Pain to be assessed with a patient reported questionaire.
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Timepoint [6]
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Up to 55 months
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Secondary outcome [7]
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Number of participants with adverse events as a measure of safety
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Assessment method [7]
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Timepoint [7]
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Up to 55 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/02/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/09/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
662
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Northern Cancer Institute - St Leonards
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Macquarie University Hospital - Sydney
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Nepean Hospital - Sydney
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Cancer Research South Australia - South Terrace
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Recruitment hospital [5]
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Peninsula Oncology Centre - Frankston
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Recruitment hospital [6]
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Austin Health - Heidelberg
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2065 - St Leonards
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Recruitment postcode(s) [2]
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2109 - Sydney
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Recruitment postcode(s) [3]
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2751 - Sydney
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Recruitment postcode(s) [4]
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5000 - South Terrace
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Recruitment postcode(s) [5]
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3199 - Frankston
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Recruitment postcode(s) [6]
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- Heidelberg
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Recruitment outside Australia
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Brazil
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Bahia
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Zaporizhia
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Funding & Sponsors
Primary sponsor type
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Name
Bayer
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Name [1]
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Orion Corporation, Orion Pharma
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.
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Trial website
https://clinicaltrials.gov/study/NCT04736199
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT04736199
Download to PDF