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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:
ClinicalTrials.gov Identifier:
NCT00974311
First Posted: September 10, 2009
Last Update Posted: March 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
Results First Submitted: September 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, 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 
Overall Participants Analyzed 
[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  

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.  


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    Enzalutamide   Placebo
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   785/800 (98.13%)   390/399 (97.74%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   106/800 (13.25%)   70/399 (17.54%) 
Gastrointestinal disorders     
Nausea † 1     
# participants affected / at risk   263/800 (32.88%)   166/399 (41.60%) 
Constipation † 1     
# participants affected / at risk   187/800 (23.38%)   108/399 (27.07%) 
Diarrhoea † 1     
# participants affected / at risk   168/800 (21.00%)   70/399 (17.54%) 
Vomiting † 1     
# participants affected / at risk   129/800 (16.13%)   84/399 (21.05%) 
Abdominal pain † 1     
# participants affected / at risk   40/800 (5.00%)   21/399 (5.26%) 
General disorders     
Fatigue † 1     
# participants affected / at risk   269/800 (33.63%)   113/399 (28.32%) 
Asthenia † 1     
# participants affected / at risk   138/800 (17.25%)   66/399 (16.54%) 
Oedema peripheral † 1     
# participants affected / at risk   119/800 (14.88%)   50/399 (12.53%) 
Pyrexia † 1     
# participants affected / at risk   53/800 (6.63%)   23/399 (5.76%) 
Infections and infestations     
Urinary tract infection † 1     
# participants affected / at risk   59/800 (7.38%)   24/399 (6.02%) 
Investigations     
Weight decreased † 1     
# participants affected / at risk   94/800 (11.75%)   41/399 (10.28%) 
Metabolism and nutrition disorders     
Anorexia † 1     
# participants affected / at risk   200/800 (25.00%)   104/399 (26.07%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1     
# participants affected / at risk   190/800 (23.75%)   90/399 (22.56%) 
Arthralgia † 1     
# participants affected / at risk   153/800 (19.13%)   71/399 (17.79%) 
Pain in extremity † 1     
# participants affected / at risk   118/800 (14.75%)   62/399 (15.54%) 
Bone pain † 1     
# participants affected / at risk   104/800 (13.00%)   65/399 (16.29%) 
Musculoskeletal pain † 1     
# participants affected / at risk   109/800 (13.63%)   40/399 (10.03%) 
Musculoskeletal chest pain † 1     
# participants affected / at risk   63/800 (7.88%)   34/399 (8.52%) 
Muscular weakness † 1     
# participants affected / at risk   66/800 (8.25%)   27/399 (6.77%) 
Myalgia † 1     
# participants affected / at risk   49/800 (6.13%)   26/399 (6.52%) 
Nervous system disorders     
Headache † 1     
# participants affected / at risk   93/800 (11.63%)   21/399 (5.26%) 
Dizziness † 1     
# participants affected / at risk   54/800 (6.75%)   21/399 (5.26%) 
Paraesthesia † 1     
# participants affected / at risk   52/800 (6.50%)   18/399 (4.51%) 
Psychiatric disorders     
Insomnia † 1     
# participants affected / at risk   69/800 (8.63%)   24/399 (6.02%) 
Anxiety † 1     
# participants affected / at risk   51/800 (6.38%)   16/399 (4.01%) 
Depression † 1     
# participants affected / at risk   43/800 (5.38%)   18/399 (4.51%) 
Renal and urinary disorders     
Haematuria † 1     
# participants affected / at risk   46/800 (5.75%)   14/399 (3.51%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1     
# participants affected / at risk   78/800 (9.75%)   38/399 (9.52%) 
Cough † 1     
# participants affected / at risk   47/800 (5.88%)   25/399 (6.27%) 
Vascular disorders     
Hot flush † 1     
# participants affected / at risk   162/800 (20.25%)   41/399 (10.28%) 
Hypertension † 1     
# participants affected / at risk   49/800 (6.13%)   11/399 (2.76%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)



  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