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: October 8, 2014
Last verified: October 2014
Results First Received: October 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[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: Teresa Parli, MD, Director, Clinical Development
Organization: Medivation, Inc.
phone: 415-983-3005
e-mail: teresa.parli@medivation.com


No publications provided by Medivation, Inc.

Publications automatically indexed to this study:

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: October 8, 2014
Health Authority: United States: Food and Drug Administration