A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01288911
First received: February 1, 2011
Last updated: January 21, 2016
Last verified: January 2016
Results First Received: October 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostatic Neoplasms
Interventions: Drug: enzalutamide
Drug: Bicalutamide

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Men with metastatic castration-resistant prostate cancer (mCRPC) were enrolled at 84 sites in a total of 8 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were stratified by whether bilateral orchiectomy or receipt of luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy started before or after the diagnosis of metastases and by site.

Reporting Groups
  Description
Enzalutamide Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
Bicalutamide Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Participant Flow:   Overall Study
    Enzalutamide     Bicalutamide  
STARTED     184     191  
Received Treatment     183     189  
COMPLETED     59 [1]   21 [1]
NOT COMPLETED     125     170  
Death                 10                 7  
Lost to Follow-up                 0                 2  
Progressive Disease                 69                 99  
Protocol Violation                 1                 0  
Withdrawal by Subject                 21                 21  
Miscellaneous Reason                 23                 39  
Randomized but never received study drug                 1                 2  
[1] Indicates participants still receiving treatment as of 19 October 2014



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Enzalutamide Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
Bicalutamide Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
Total Total of all reporting groups

Baseline Measures
    Enzalutamide     Bicalutamide     Total  
Number of Participants  
[units: participants]
  184     191     375  
Age  
[units: years]
Mean (Standard Deviation)
  70.3  (9.22)     71.1  (8.89)     70.7  (9.05)  
Age, Customized  
[units: participants]
     
< 65 years     45     47     92  
65-75 years     85     80     165  
> 75 years     54     64     118  
Gender  
[units: participants]
     
Female     0     0     0  
Male     184     191     375  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (PFS) Based on Independent Central Review (ICR) Assessment   [ Time Frame: From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ]

2.  Secondary:   PFS Based on Investigator Assessment   [ Time Frame: From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ]

3.  Secondary:   Prostate-specific Antigen (PSA) Response by Week 13   [ Time Frame: Baseline to Week 13 ]

4.  Secondary:   Best Prostate-specific Antigen (PSA) Response   [ Time Frame: Baseline to the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ]

5.  Secondary:   Time to PSA Progression   [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ]

6.  Secondary:   Time to PSA ≤ 4 ng/mL   [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ]

7.  Secondary:   Time to ≥ 30% PSA Decline From Baseline   [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ]

8.  Secondary:   Time to ≥ 50% PSA Decline From Baseline   [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ]

9.  Secondary:   Time to ≥ 90% PSA Decline From Baseline   [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ]

10.  Secondary:   Radiographic PFS Based on ICR Assessment   [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ]

11.  Secondary:   Percentage of Participants With an Objective Response   [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ]

12.  Secondary:   Percentage of Participants With Adverse Events   [ Time Frame: From initiation of study drug up to 30 days after the last dose of study drug or the 30-day safety follow-up visit, whichever occurred last. Median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Executive Medical Director
Organization: Astellas Pharma Global Development, Inc. (APGD)
e-mail: Astellas.resultsdisclosure@astellas.com


No publications provided


Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01288911     History of Changes
Other Study ID Numbers: 9785-CL-0222
2010-021868-15 ( EudraCT Number )
Study First Received: February 1, 2011
Results First Received: October 15, 2015
Last Updated: January 21, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Romania: National Medicines Agency
Denmark: Danish Health and Medicines Authority