Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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: December 20, 2016
Last verified: December 2016
Results First Received: February 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer
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
No text entered.

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
  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, 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  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: 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: December 20, 2016