Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00974311
First received: September 9, 2009
Last updated: February 22, 2014
Last verified: February 2014
Results First Received: September 28, 2012  
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: Castration-Resistant 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 2:1 to receive either Enzalutamide or placebo

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.

Participant Flow:   Overall Study
    Enzalutamide     Placebo  
STARTED     800     399  
COMPLETED     254 [1]   163 [1]
NOT COMPLETED     546     236  
Lost to Follow-up                 1                 1  
Death                 305                 211  
Withdrawal of consent                 9                 5  
Continuing Treatment                 231                 19  
[1] Indicates participants continuing long-term follow-up as of 25 September 2011.



  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.
No text entered.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
Total Total of all reporting groups

Baseline Measures
    Enzalutamide     Placebo     Total  
Number of Participants  
[units: participants]
  800     399     1199  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     232     130     362  
>=65 years     568     269     837  
Age  
[units: years]
Mean ± Standard Deviation
  68.8  ± 7.96     68.6  ± 8.39     68.7  ± 8.11  
Gender  
[units: participants]
     
Female     0     0     0  
Male     800     399     1199  
Region of Enrollment  
[units: participants]
     
United States     181     107     288  
Spain     23     13     36  
Austria     15     10     25  
Chile     6     5     11  
United Kingdom     82     50     132  
Italy     20     10     30  
France     193     80     273  
Canada     82     25     107  
Argentina     7     3     10  
Belgium     27     18     45  
Poland     7     4     11  
Australia     60     33     93  
South Africa     3     3     6  
Germany     62     24     86  
Netherlands     32     14     46  



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

2.  Secondary:   Radiographic Progression-free Survival   [ Time Frame: During study period (up to 3 years) ]

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

4.  Secondary:   Functional Assessment of Cancer Therapy - Prostate (FACT-P)   [ Time Frame: During study period (up to 3 years) ]

5.  Secondary:   Time to Prostate-specific Antigen (PSA) Progression   [ Time Frame: Baseline and at every study visit from week 13 while on study drug (up to 3 years) ]

6.  Secondary:   Percentage of Patients With Pain Palliation   [ Time Frame: During study period (up to 3 years) ]

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

8.  Secondary:   Percentage of Patients With Soft-tissue Objective Response   [ Time Frame: During study period (up to 3 years) ]

9.  Secondary:   European Quality of Life Five-Domain Scale (EQ-5D)   [ Time Frame: At Week 13 visit ]
Results not yet reported.   Anticipated Reporting Date:   12/2013   Safety Issue:   No

10.  Secondary:   Circulating Tumor Cell (CTC) Conversion Rate   [ Time Frame: During study period (up to 3 years) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


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