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Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer (STRIVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01664923
First received: August 10, 2012
Last updated: May 9, 2016
Last verified: May 2016
Results First Received: February 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Enzalutamide
Drug: Bicalutamide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Enzalutamide Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
Bicalutamide Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.

Participant Flow:   Overall Study
    Enzalutamide     Bicalutamide  
STARTED     198     198  
Received Study Treatment     197     198  
COMPLETED     105 [1]   40 [1]
NOT COMPLETED     93     158  
Death                 1                 0  
Lost to Follow-up                 0                 1  
Protocol Violation                 2                 0  
Withdrawal by Subject                 11                 5  
Disease Progression                 58                 139  
Adverse Event                 16                 12  
Miscellaneous                 5                 1  
[1] Indicates participants continuing to receive treatment as of 09 February 2015.



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Enzalutamide Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
Bicalutamide Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
Total Total of all reporting groups

Baseline Measures
    Enzalutamide     Bicalutamide     Total  
Number of Participants  
[units: participants]
  198     198     396  
Age, Customized  
[units: participants]
     
< 65 years     39     25     64  
65-74 years     82     76     158  
≥ 75 years     77     97     174  
Gender, Customized  
[units: participants]
     
Male     198     198     396  
Region of Enrollment  
[units: participants]
     
United States     198     198     396  



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. ]

2.  Secondary:   Time to PSA Progression   [ Time Frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. ]

3.  Secondary:   Percentage of Participants With a PSA Response ≥ 50%   [ Time Frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. ]

4.  Secondary:   Duration of Radiographic PFS   [ Time Frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. ]

5.  Secondary:   Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)   [ Time Frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. ]

6.  Secondary:   Best Overall Soft Tissue Response   [ Time Frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm. ]

7.  Secondary:   Percentage of Participants With Adverse Event (AE)   [ Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Median duration of the AE reporting period was 15.2 months in the enzalutamide arm and 9.4 months in the bicalutamide arm. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Medical Director, Clinical Development
Organization: Medivation, Inc.
e-mail: TrialDisclosure@medivation.com



Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01664923     History of Changes
Other Study ID Numbers: MDV3100-09
Study First Received: August 10, 2012
Results First Received: February 22, 2016
Last Updated: May 9, 2016
Health Authority: United States: Food and Drug Administration