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 posted.   Anticipated Posting 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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


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

Serious Adverse Events
    Enzalutamide     Placebo  
Total, serious adverse events      
# participants affected / at risk     268/800 (33.50%)     154/399 (38.60%)  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     21/800 (2.63%)     12/399 (3.01%)  
Anaemia of malignant disease † 1    
# participants affected / at risk     2/800 (0.25%)     1/399 (0.25%)  
Disseminated intravascular coagulation † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Pancytopenia † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Thrombocytopenia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Leukocytosis † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Cardiac disorders      
Cardiac failure † 1    
# participants affected / at risk     2/800 (0.25%)     2/399 (0.50%)  
Angina pectoris † 1    
# participants affected / at risk     2/800 (0.25%)     1/399 (0.25%)  
Acute myocardial infarction † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Cardiac failure congestive † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Atrial flutter † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Bradycardia † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Cardiogenic shock † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Left ventricular failure † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Mitral valve incompetance † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Ventricular fibrillation † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Arrhythmia supraventricular † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Atrial fibrillation † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Atrioventricular block complete † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Myocardial ischaemia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Myocardial infarction † 1    
# participants affected / at risk     0/800 (0.00%)     2/399 (0.50%)  
Congenital, familial and genetic disorders      
Adenomatous polyposis coli † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Ear and labyrinth disorders      
Ear pain † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Vertigo † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Endocrine disorders      
Adrenal insufficiency † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Eye disorders      
Retinal detachment † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Papilloedema † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Visual acuity reduced † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Visual impairment † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Gastrointestinal disorders      
Vomiting † 1    
# participants affected / at risk     2/800 (0.25%)     8/399 (2.01%)  
Nausea † 1    
# participants affected / at risk     5/800 (0.63%)     3/399 (0.75%)  
Constipation † 1    
# participants affected / at risk     5/800 (0.63%)     3/399 (0.75%)  
Rectal haemorrhage † 1    
# participants affected / at risk     2/800 (0.25%)     3/399 (0.75%)  
Abdominal pain † 1    
# participants affected / at risk     1/800 (0.13%)     2/399 (0.50%)  
Diarrhoea † 1    
# participants affected / at risk     3/800 (0.38%)     0/399 (0.00%)  
Small intestinal obstruction † 1    
# participants affected / at risk     3/800 (0.38%)     0/399 (0.00%)  
Colonic obstruction † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Faecaloma † 1    
# participants affected / at risk     0/800 (0.00%)     2/399 (0.50%)  
Gastrointestinal haemorrhage † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Intestinal obstruction † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Abdominal pain lower † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Colitis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Gastric ulcer haemorrhage † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Gastrointestinal obstruction † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Haematochezia † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Intestinal perforation † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Large intestine perforation † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Pancreatitis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Proctalgia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Retroperitoneal haemorrhage † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Intestinal mass † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Pancreatitis acute † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Peptic ulcer † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
General disorders      
General physical health deterioration † 1    
# participants affected / at risk     17/800 (2.13%)     8/399 (2.01%)  
Asthenia † 1    
# participants affected / at risk     3/800 (0.38%)     3/399 (0.75%)  
Pain † 1    
# participants affected / at risk     5/800 (0.63%)     1/399 (0.25%)  
Fatigue † 1    
# participants affected / at risk     2/800 (0.25%)     3/399 (0.75%)  
Pyrexia † 1    
# participants affected / at risk     2/800 (0.25%)     5/399 (1.25%)  
Oedema peripheral † 1    
# participants affected / at risk     1/800 (0.13%)     3/399 (0.75%)  
Malaise † 1    
# participants affected / at risk     2/800 (0.25%)     2/399 (0.50%)  
Chest pain † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Death † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Euthanasia † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
General symptom † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Immune system disorders      
Anaphylactic reaction † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Infections and infestations      
Pneumonia † 1    
# participants affected / at risk     12/800 (1.50%)     5/399 (1.25%)  
Urinary tract infection † 1    
# participants affected / at risk     7/800 (0.88%)     5/399 (1.25%)  
Urosepsis † 1    
# participants affected / at risk     4/800 (0.50%)     1/399 (0.25%)  
Sepsis † 1    
# participants affected / at risk     3/800 (0.38%)     1/399 (0.25%)  
Gastroenteritis † 1    
# participants affected / at risk     1/800 (0.13%)     2/399 (0.50%)  
Bronchitis † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Device related infection † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Escherichia sepsis † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Lobar pneumonia † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Staphylococcal sepsis † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Cellulitis † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Erysipelas † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Lower respiratory tract infection † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Abdominal abscess † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Catheter bacteraemia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Chest wall abscess † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Clostridium difficile colitis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Cystitis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Extradural abscess † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Infection † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Infective exacerbation of chronic obstructive airways disease † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Kidney infection † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Klebsiella bacteraemia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Parotitis † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Pneumonia bacterial † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Rectal abscess † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Respiratory tract infection † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Septic Shock † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Tooth Infection † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Upper respiratory tract infection † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Herpes zoster † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Viral pericarditis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Injury, poisoning and procedural complications      
Subdural haematoma † 1    
# participants affected / at risk     2/800 (0.25%)     1/399 (0.25%)  
Femur fracture † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Fall † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Femoral neck fracture † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Fracture † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Hip fracture † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Lumbar vertebral fracture † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Medical device complication † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Patella fracture † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Post procedural haematuria † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Post-traumatic pain † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Radiation oesophagitis † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Soft tissue injury † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Spinal compression fracture † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Hand fracture † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Thoracic vertebral fracture † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Investigations      
Liver function test abnormal † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Weight decreased † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     3/800 (0.38%)     3/399 (0.75%)  
Hyponatraemia † 1    
# participants affected / at risk     2/800 (0.25%)     3/399 (0.75%)  
Hypoglycaemia † 1    
# participants affected / at risk     1/800 (0.13%)     2/399 (0.50%)  
Hypercalcaemia † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Anorexia † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Hyperuricaemia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Hypocalcaemia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Hypokalaemia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Hypophosphataemia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Hypovolaemia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Cachexia † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Musculoskeletal and connective tissue disorders      
Back pain † 1    
# participants affected / at risk     11/800 (1.38%)     7/399 (1.75%)  
Bone pain † 1    
# participants affected / at risk     12/800 (1.50%)     4/399 (1.00%)  
Pathological fracture † 1    
# participants affected / at risk     12/800 (1.50%)     2/399 (0.50%)  
Pain in extremity † 1    
# participants affected / at risk     3/800 (0.38%)     2/399 (0.50%)  
Arthralgia † 1    
# participants affected / at risk     3/800 (0.38%)     1/399 (0.25%)  
Muscular weakness † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Myalgia † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Osteonecrosis † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Musculoskeletal chest pain † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Chondrocalcinosis pyrophosphate † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Flank pain † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Intervertebral disc protrusion † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Muscle haemorrhage † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Osteoarthritis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Rhabdomyolysis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Spinal column stenosis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Osteitis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Metastatic pain † 1    
# participants affected / at risk     12/800 (1.50%)     3/399 (0.75%)  
Cancer pain † 1    
# participants affected / at risk     8/800 (1.00%)     5/399 (1.25%)  
Metastases to central nervous system † 1    
# participants affected / at risk     4/800 (0.50%)     1/399 (0.25%)  
Metastases to Bone † 1    
# participants affected / at risk     1/800 (0.13%)     5/399 (1.25%)  
Malignant pleural effusion † 1    
# participants affected / at risk     2/800 (0.25%)     1/399 (0.25%)  
Tumour pain † 1    
# participants affected / at risk     0/800 (0.00%)     3/399 (0.75%)  
Acute leukaemia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Acute monocytic leukaemia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Bone marrow tumour cell infiltration † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Metastases to liver † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Metastases to meninges † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Neoplasm progression † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Small cell lung cancer stage unspecified † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Transitional cell carcinoma † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Bronchial carcinoma † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Gastrointestinal tract adenoma † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Metastases to lung † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Nervous system disorders      
Spinal cord compression † 1    
# participants affected / at risk     48/800 (6.00%)     15/399 (3.76%)  
Cauda equina syndrome † 1    
# participants affected / at risk     6/800 (0.75%)     0/399 (0.00%)  
Nerve root compression † 1    
# participants affected / at risk     1/800 (0.13%)     4/399 (1.00%)  
Syncope † 1    
# participants affected / at risk     3/800 (0.38%)     2/399 (0.50%)  
Cerebrovascular accident † 1    
# participants affected / at risk     3/800 (0.38%)     1/399 (0.25%)  
Hepatic encephalopathy † 1    
# participants affected / at risk     1/800 (0.13%)     2/399 (0.50%)  
Dizziness † 1    
# participants affected / at risk     2/800 (0.25%)     1/399 (0.25%)  
Transient ischemic attack † 1    
# participants affected / at risk     3/800 (0.38%)     1/399 (0.25%)  
Cerebral haemorrhage † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Convulsion † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Cranial neuropathy † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Epiduritis † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Nerve compression † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Partial seizures † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Lethargy † 1    
# participants affected / at risk     3/800 (0.38%)     0/399 (0.00%)  
Headache † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Akathisia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Central nervous system lesion † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Cranial nerve palsies multiple † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Embolic stroke † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Facial palsy † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Haemorrhage intracranial † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Haemorrhagic stroke † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Ischaemic stroke † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Lacunar infarction † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Loss of consciousness † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Lumbar radiculopathy † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Motor dysfunction † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Pachymeningitis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Presyncope † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Status epilepticus † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Hypoglossal nerve paresis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Normal pressure hydrocephalus † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Tremor † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Trigeminal neuralgia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Visual field defect † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Psychiatric disorders      
Confusional state † 1    
# participants affected / at risk     2/800 (0.25%)     2/399 (0.50%)  
Depressed mood † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Hallucination † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Mental status changes † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Depression † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Disorientation † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Renal and urinary disorders      
Haematuria † 1    
# participants affected / at risk     12/800 (1.50%)     5/399 (1.25%)  
Urinary retention † 1    
# participants affected / at risk     3/800 (0.38%)     8/399 (2.01%)  
Urinary tract obstruction † 1    
# participants affected / at risk     7/800 (0.88%)     1/399 (0.25%)  
Post renal failure † 1    
# participants affected / at risk     3/800 (0.38%)     3/399 (0.75%)  
Renal failure † 1    
# participants affected / at risk     3/800 (0.38%)     3/399 (0.75%)  
Renal failure acute † 1    
# participants affected / at risk     2/800 (0.25%)     3/399 (0.75%)  
Bladder perforation † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Hydronephrosis † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Nephrolithiasis † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Cystitis haemorrhagic † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Renal colic † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Bladder obstruction † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Dysuria † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Obstructive uropathy † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Ureteric obstruction † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Urethral obstruction † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Urethral stenosis † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Reproductive system and breast disorders      
Pelvic pain † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Respiratory, thoracic and mediastinal disorders      
Pulmonary embolism † 1    
# participants affected / at risk     3/800 (0.38%)     4/399 (1.00%)  
Pleural effusion † 1    
# participants affected / at risk     2/800 (0.25%)     3/399 (0.75%)  
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     3/800 (0.38%)     0/399 (0.00%)  
Pneumothorax † 1    
# participants affected / at risk     2/800 (0.25%)     1/399 (0.25%)  
Epistaxis † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Pulmonary oedema † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Dyspnoea † 1    
# participants affected / at risk     1/800 (0.13%)     1/399 (0.25%)  
Acute pulmonary oedema † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Haemoptysis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Respiratory arrest † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Hydropneumothorax † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Pleuritic pain † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Skin and subcutaneous tissue disorders      
Hyperhidrosis † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Vascular purpura † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Surgical and medical procedures      
Bladder catheter removal † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Limb operation † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Pain management † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Cataract operation † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Colon polypectomy † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Oesophageal dilation procedure † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Pleurodesis † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Ureteral stent insertion † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Vascular disorders      
Deep vein thrombosis † 1    
# participants affected / at risk     3/800 (0.38%)     3/399 (0.75%)  
Haematoma † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Lymphoedema † 1    
# participants affected / at risk     2/800 (0.25%)     0/399 (0.00%)  
Hypertensive crisis † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Hypotension † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Peripheral ischaemia † 1    
# participants affected / at risk     1/800 (0.13%)     0/399 (0.00%)  
Orthostatic hypotension † 1    
# participants affected / at risk     0/800 (0.00%)     1/399 (0.25%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)




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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.


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
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Results Point of Contact:  
Name/Title: Lynn Seely, MD, Chief Medical Officer
Organization: Medivation, Inc.
phone: 415-829-4106
e-mail: lynn.seely@medivation.com


No publications provided by Medivation, Inc.

Publications automatically indexed to this study:

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00974311     History of Changes
Other Study ID Numbers: CRPC2
Study First Received: September 9, 2009
Results First Received: September 28, 2012
Last Updated: February 22, 2014
Health Authority: United States: Food and Drug Administration