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A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer (PREVAIL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01212991
First received: September 29, 2010
Last updated: February 12, 2016
Last verified: February 2016
Results First Received: October 8, 2014  
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: Placebo

  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
Multicenter, global clinical trial

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized 1:1 to receive either enzalutamide or placebo

Reporting Groups
  Description
Enzalutamide Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Placebo Participants received placebo, administered as four capsules, once per day by mouth.

Participant Flow:   Overall Study
    Enzalutamide   Placebo
STARTED   872   845 
COMPLETED   259 [1]   471 [1] 
NOT COMPLETED   613   374 
Lost to Follow-up                1                0 
Death                241                299 
Withdrawal by Subject                4                14 
Continuing Treatment                367                61 
[1] Indicates participants continuing in long-term follow-up as of 16SEP2013.



  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, administered as four 40-mg capsules, once per day by mouth.
Placebo Participants received placebo, administered as four capsules, once per day by mouth.
Total Total of all reporting groups

Baseline Measures
   Enzalutamide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 872   845   1717 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.3  (8.51)   71.2  (8.42)   71.3  (8.47) 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   179   179   358 
>=65 years   693   666   1359 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   872   845   1717 
Region of Enrollment 
[Units: Participants]
     
United States   127   120   247 
Slovakia   13   14   27 
Finland   18   15   33 
Spain   44   37   81 
Lithuania   8   6   14 
Austria   9   9   18 
Russian Federation   12   10   22 
Israel   14   11   25 
United Kingdom   78   75   153 
Italy   15   15   30 
France   85   90   175 
Canada   91   88   179 
Poland   21   18   39 
Belgium   28   29   57 
Singapore   5   4   9 
Australia   116   116   232 
Denmark   43   44   87 
Netherlands   15   13   28 
Germany   41   42   83 
Japan   28   33   61 
Sweden   21   18   39 
Korea, Republic of   40   38   78 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: During study period (up to 3 years) ]

2.  Primary:   Radiographic Progression-free Survival   [ Time Frame: During study period (up to 20 months) ]

3.  Secondary:   Time to First Skeletal-related Event   [ Time Frame: During study period (up to 3 years) ]

4.  Secondary:   Time to Initiation of Cytotoxic Chemotherapy   [ Time Frame: During study period (up to 3 years) ]

5.  Secondary:   Time to Prostate-specific Antigen (PSA) Progression   [ Time Frame: During study period (up to 3 years) ]

6.  Secondary:   Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%   [ Time Frame: During study period (up to 3 years) ]

7.  Secondary:   Best Overall Soft Tissue Response   [ Time Frame: During study period (up to 3 years) ]


  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: Phillip Cole, MD
Organization: Medivation, Inc.
e-mail: phillip.cole@medivation.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01212991     History of Changes
Other Study ID Numbers: MDV3100-03
Study First Received: September 29, 2010
Results First Received: October 8, 2014
Last Updated: February 12, 2016