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Trial record 1 of 1 for:    ARASENS
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ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS)

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ClinicalTrials.gov Identifier: NCT02799602
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE June 6, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE November 30, 2016
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
Overall survival [ Time Frame: approximately 70 months ]
From date of randomization until death from any cause, during treatment and during active and long term follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02799602 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
  • Time to castration resistant prostate cancer [ Time Frame: approximately 70 months ]
    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.
  • Time to initiation of subsequent antineoplastic therapy [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the date of first subsequent antineoplastic therapy for prostate cancer.
  • Symptomatic skeletal event free survival (SSE-FS) [ Time Frame: approximately 70 months ]
    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.
  • Time to first symptomatic skeletal event (SSE) [ Time Frame: approximately 70 months ]
    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.
  • Time to initiation of opioid use [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the opiod use.
  • Time to pain progression [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the first date a subject experiences a pain progression. Pain to be assessed with a patient reported questionaire.
  • Time to worsening of physical symptoms of disease [ Time Frame: approximately 70 months ]
    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.
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: approximately 70 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
  • Time to castration resistant prostate cancer [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the time of PSA progression or progression by soft tissue lesions or progression by bone lesions, whatever comes first.
  • Time to initiation of subsequent antineoplastic therapy [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the date of first subsequent antineoplastic therapy for prostate cancer.
  • Symptomatic skeletal event free survival (SSE-FS) [ Time Frame: approximately 70 months ]
    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.
  • Time to first symptomatic skeletal event (SSE) [ Time Frame: approximately 70 months ]
    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.
  • Time to initiation of opioid use [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the opiod use.
  • Time to pain progression [ Time Frame: approximately 70 months ]
    Every 12 weeks up to the first date a subject experiences a pain progression. Pain to be assessed with a patient reported questionaire.
  • Time to worsening of physical symptoms of disease [ Time Frame: approximately 70 months ]
    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.
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: approximately 70 months ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
Official Title  ICMJE 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
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.
Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter phase III study. The study population will consist of approximately 1300 subjects with metastatic hormone sensitive prostate cancer (mHSPC), who will be randomized (1:1 ratio) to receive 600 mg (2 x 300 mg tablets) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total daily dose of 1200 mg, in addition to standard androgen deprivation therapy (ADT) and docetaxel. Subjects will be stratified at randomization for the extent of disease and for Alkaline Phosphatase levels. All subjects will be treated with ADT as standard therapy. Six cycles of docetaxel will be administered after randomization.

The subjects considered for inclusion in the study will have metastatic prostate cancer and will be candidates for ADT and docetaxel.

Treatment with darolutamide (ODM-201)/placebo will be administered until symptomatic progressive disease, change of antineoplastic therapy, unacceptable toxicity, until subject withdraws consent, withdrawal from the study at the discretion of the Investigator or his/her designated associate(s), death, non-compliance, or if Sponsor terminates the study.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE
  • Drug: 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
  • Drug: Standard ADT (androgen deprivation therapy)
    As prescribed by the treating physician.
  • Drug: Docetaxel
    As prescribed by the treating physician.
  • Drug: 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.
Study Arms
  • Experimental: BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel
    Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel
    Interventions:
    • Drug: BAY1841788 / darolutamide (ODM-201)
    • Drug: Standard ADT (androgen deprivation therapy)
    • Drug: Docetaxel
  • Placebo Comparator: Placebo + standard ADT + Docetaxel
    Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel
    Interventions:
    • Drug: Standard ADT (androgen deprivation therapy)
    • Drug: Docetaxel
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 20, 2018)
1303
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2016)
1300
Estimated Study Completion Date August 1, 2022
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czechia,   Finland,   France,   Germany,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT02799602
Other Study ID Numbers  ICMJE 17777
2015-002590-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Orion Corporation, Orion Pharma
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP