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Trial record 1 of 1 for:    P12-2
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A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer

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.
 
ClinicalTrials.gov Identifier: NCT01981122
Recruitment Status : Completed
First Posted : November 11, 2013
Results First Posted : September 25, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Dendreon

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Metastatic Prostate Cancer
Interventions Biological: sipuleucel-T
Drug: enzalutamide
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Concurrent Arm Sequential Arm
Hide Arm/Group Description

Subjects will receive sipuleucel-T concurrently with enzalutamide (160 mg orally once daily). Enzalutamide treatment will start 2 weeks prior to the first leukapheresis and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.

sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.

Subjects will receive sipuleucel-T followed by enzalutamide (160 mg orally once daily). Enzalutamide treatment will start approximately 10 weeks after the first infusion of sipuleucel-T and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.

sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.

Period Title: Overall Study
Started 25 27
Completed 11 7
Not Completed 14 20
Reason Not Completed
Withdrawal by Subject             0             2
Protocol Violation             0             1
Lost to Follow-up             0             1
Investigator Or Dendreon Discretion             0             1
Death             14             15
Arm/Group Title Concurrent Arm Sequential Arm Total
Hide Arm/Group Description

Subjects will receive sipuleucel-T concurrently with enzalutamide (160 mg orally once daily). Enzalutamide treatment will start 2 weeks prior to the first leukapheresis and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.

sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.

Subjects will receive sipuleucel-T followed by enzalutamide (160 mg orally once daily). Enzalutamide treatment will start approximately 10 weeks after the first infusion of sipuleucel-T and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.

sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.

Total of all reporting groups
Overall Number of Baseline Participants 25 27 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  40.0%
4
  14.8%
14
  26.9%
>=65 years
15
  60.0%
23
  85.2%
38
  73.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 52 participants
66.4  (10.6) 73.3  (9.0) 70.0  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
25
 100.0%
27
 100.0%
52
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   7.4%
2
   3.8%
White
25
 100.0%
25
  92.6%
50
  96.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 27 participants 52 participants
25
 100.0%
27
 100.0%
52
 100.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 25 participants 27 participants 52 participants
177.0  (8.0) 177.2  (6.0) 177.1  (6.9)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 25 participants 27 participants 52 participants
94.6  (19.4) 91.2  (13.9) 92.8  (16.6)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 25 participants 27 participants 52 participants
30.3  (5.1) 29.0  (4.2) 29.6  (4.6)
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
ECOG 0=Fully Active; No restrictions
22
  88.0%
19
  70.4%
41
  78.8%
ECOG 1=Restricted Strenuous Activity
3
  12.0%
8
  29.6%
11
  21.2%
[1]
Measure Description: ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about >50% of waking hour; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead
Gleason Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
Gleason Score ≤6
1
   4.0%
2
   7.4%
3
   5.8%
Gleason Score 7
4
  16.0%
8
  29.6%
12
  23.1%
Gleason Score ≥8
19
  76.0%
16
  59.3%
35
  67.3%
Missing
1
   4.0%
1
   3.7%
2
   3.8%
[1]
Measure Description: Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread.
Time from Diagnosis to Randomization  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 52 participants
5.1  (5.3) 6.5  (5.6) 5.8  (5.5)
Time in Years   [1] 
Measure Type: Number
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 52 participants
0-5 16 14 30
6-10 5 5 10
11-15 3 6 9
16-20 0 1 1
21-25 1 1 2
[1]
Measure Description: Categorical presentation of participants based on time from diagnosis to randomization in this study
1.Primary Outcome
Title To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).
Hide Description PA2024-specific T cell proliferation responses over time will be compared between the concurrent arm and sequential arm using a repeated measurement mixed model analysis. The unit of analysis for the T cell proliferation data is the stimulation index, defined as the median 3H uptake of 3 wells exposed to antigen divided by the median 3H thymidine uptake of 3 wells exposed to media. The stimulation index will be log-transformed prior to analysis.
Time Frame Each patient was followed for up to 52 weeks after the first dose of sipuleucel-T. Immune sample draws during the treatment period (Week 0 through Week 4) were to be performed at the patient's pre-leukapheresis visits (Pre-Leuk 2 and Pre-Leuk 3).
Hide Outcome Measure Data
Hide Analysis Population Description
Summary of Cellular Proliferation Data Through Week 52. All patients with reported data at a specified time-point were analyzed. Number of patients at each time-point differed across the time-points resulting in patient numbers at each time-point that are not equal to the total number of patients analyzed.
Arm/Group Title Concurrent Arm Sequential Arm
Hide Arm/Group Description:

Subjects will receive sipuleucel-T concurrently with enzalutamide (160 mg orally once daily). Enzalutamide treatment will start 2 weeks prior to the first leukapheresis and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.

sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.

Subjects will receive sipuleucel-T followed by enzalutamide (160 mg orally once daily). Enzalutamide treatment will start approximately 10 weeks after the first infusion of sipuleucel-T and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.

sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.

Overall Number of Participants Analyzed 23 26
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/mL
PA2024 Baseline Number Analyzed 23 participants 25 participants
2.48  (4.76) 1.48  (.92)
PA2024 Pre-leuk 2 Number Analyzed 21 participants 26 participants
8.76  (13.40) 5.08  (7.07)
PA2024 Pre-leuk 3 Number Analyzed 21 participants 25 participants
23.33  (16.98) 13.96  (11.90)
PA2024 Week 6 Number Analyzed 22 participants 18 participants
17.36  (14.39) 12.72  (11.83)
PA2024 Week 10 Number Analyzed 21 participants 21 participants
15.48  (9.53) 10.90  (9.07)
PA2024 Week 14 Number Analyzed 22 participants 21 participants
17.05  (18.72) 13.05  (13.28)
PA2024 Week 20 Number Analyzed 21 participants 18 participants
22.33  (20.23) 17.83  (13.80)
PA2024 Week 26 Number Analyzed 15 participants 18 participants
27.07  (18.26) 15.39  (10.58)
PA2024 Week 40 Number Analyzed 11 participants 10 participants
18.64  (15.48) 13.70  (11.28)
PA2024 Week 52 Number Analyzed 9 participants 7 participants
16.67  (13.13) 25.43  (18.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Concurrent Arm, Sequential Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .095
Comments [Not Specified]
Method Mixed Models Analysis
Comments Repeated Measures
Time Frame All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Concurrent Arm Sequential Arm
Hide Arm/Group Description

Subjects will receive sipuleucel-T concurrently with enzalutamide (160 mg orally once daily). Enzalutamide treatment will start 2 weeks prior to the first leukapheresis and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.

sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.

Subjects will receive sipuleucel-T followed by enzalutamide (160 mg orally once daily). Enzalutamide treatment will start approximately 10 weeks after the first infusion of sipuleucel-T and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.

sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.

All-Cause Mortality
Concurrent Arm Sequential Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   14/25 (56.00%)      15/27 (55.56%)    
Hide Serious Adverse Events
Concurrent Arm Sequential Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/25 (8.00%)      9/27 (33.33%)    
Blood and lymphatic system disorders     
Anaemia  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Cardiac disorders     
Atrial Flutter  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Cardiac Failure Congestive  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Eye disorders     
Conjunctival Haemorrhage  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Gastrointestinal disorders     
Vomiting  1  1/25 (4.00%)  1 0/27 (0.00%)  0
General disorders     
Thrombosis In Device  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Infections and infestations     
Sepsis  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Urinary Tract Infection  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Injury, poisoning and procedural complications     
Eye Injury  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Face Injury  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Fall  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Femur Fracture  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Laceration  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Road Traffic Accident  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Dysarthria  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Headache  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Loss of Consciousness  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Spinal Cord Compression  1  0/25 (0.00%)  0 2/27 (7.41%)  2
Renal and urinary disorders     
Urinary Incotinence  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Sinus Disorder  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Vascular disorders     
Deep Vein Thrombosis  1  0/25 (0.00%)  0 1/27 (3.70%)  1
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.9%
Concurrent Arm Sequential Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/25 (92.00%)      27/27 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  1  3/25 (12.00%)  4 2/27 (7.41%)  2
Iron Deficiency Anaemia  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Cardiac disorders     
Angina Pectoris  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Aortic Valve Incompetence  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Atrial Fibrillation  1  1/25 (4.00%)  1 1/27 (3.70%)  1
Palpitations  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Tachycardia  1  2/25 (8.00%)  2 2/27 (7.41%)  4
Eye disorders     
Cataract  1  1/25 (4.00%)  1 1/27 (3.70%)  1
Dry Eye  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Macular Degeneration  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Retinal Haemorrhage  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Vitreous Detachment  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Vitreous Floaters  1  0/25 (0.00%)  0 2/27 (7.41%)  2
Gastrointestinal disorders     
Abdominal Distension  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Abdominal Pain  1  1/25 (4.00%)  1 3/27 (11.11%)  3
Constipation  1  0/25 (0.00%)  0 6/27 (22.22%)  6
Dental Caries  1  0/25 (0.00%)  0 2/27 (7.41%)  2
Diarrhoea  1  2/25 (8.00%)  3 1/27 (3.70%)  1
Dry Mouth  1  2/25 (8.00%)  2 0/27 (0.00%)  0
Dyspepsia  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Dysphagia  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Eructation  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Flatulence  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Gastrooesophageal Reflux Disease  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Haemorrhoids  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Nausea  1  7/25 (28.00%)  8 7/27 (25.93%)  10
Paraesthesis Oral  1  3/25 (12.00%)  5 5/27 (18.52%)  5
Vomiting  1  2/25 (8.00%)  2 2/27 (7.41%)  2
General disorders     
Application Site Rash  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Asthenia  1  1/25 (4.00%)  1 3/27 (11.11%)  4
Chest Discomfort  1  0/25 (0.00%)  0 2/27 (7.41%)  3
Chest Pain  1  1/25 (4.00%)  1 3/27 (11.11%)  3
Chills  1  2/25 (8.00%)  4 7/27 (25.93%)  12
Fatigue  1  9/25 (36.00%)  11 17/27 (62.96%)  19
Infusion Site Inflammation  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Injection Site Pain  1  2/25 (8.00%)  2 0/27 (0.00%)  0
Injection Site Reaction  1  1/25 (4.00%)  2 0/27 (0.00%)  0
Malaise  1  1/25 (4.00%)  2 0/27 (0.00%)  0
Oedema Peripheral  1  1/25 (4.00%)  1 4/27 (14.81%)  5
Pain  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Pyrexia  1  0/25 (0.00%)  0 3/27 (11.11%)  4
Immune system disorders     
Seasonal Allergy  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Infections and infestations     
Cellulitis  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Clostridium Difficile Colitis  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Cystitis  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Dysentery  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Herpes Zoster  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Hordeolum  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Nasopharyngitis  1  2/25 (8.00%)  2 1/27 (3.70%)  1
Pneumonia  1  1/25 (4.00%)  1 1/27 (3.70%)  1
Sinusitis  1  2/25 (8.00%)  2 2/27 (7.41%)  2
Upper Respiratory Tract Infection  1  1/25 (4.00%)  1 3/27 (11.11%)  3
Urinary Tract Infection  1  1/25 (4.00%)  1 3/27 (11.11%)  3
Injury, poisoning and procedural complications     
Arthropod Bite  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Contusion  1  3/25 (12.00%)  3 1/27 (3.70%)  1
Excoriation  1  1/25 (4.00%)  1 1/27 (3.70%)  1
Fall  1  2/25 (8.00%)  2 3/27 (11.11%)  3
Infusion Related Reaction  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Laceration  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Tooth Fracture  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Investigations     
Blood Creatinine Increased  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Body Temperature Increased  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Weight Decreased  1  1/25 (4.00%)  1 1/27 (3.70%)  1
Weight Increased  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Decreased Appetite  1  2/25 (8.00%)  2 3/27 (11.11%)  3
Dehydration  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Hypomagnesaemia  1  0/25 (0.00%)  0 2/27 (7.41%)  2
Hyponatraemia  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Hypophosphataemia  1  1/25 (4.00%)  2 0/27 (0.00%)  0
Malnutrition  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Type 2 Diabetes Mellitus  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Vitamin B12 Deficiency  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Vitamin D Deficiency  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/25 (12.00%)  4 5/27 (18.52%)  8
Back Pain  1  7/25 (28.00%)  8 3/27 (11.11%)  4
Bone Pain  1  1/25 (4.00%)  1 1/27 (3.70%)  1
Flank Pain  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Groin Pain  1  1/25 (4.00%)  1 1/27 (3.70%)  1
Joint Crepitation  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Mobility Decreased  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Muscle Spasms  1  0/25 (0.00%)  0 2/27 (7.41%)  2
Muscle Tightness  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Muscular Weakness  1  1/25 (4.00%)  1 2/27 (7.41%)  2
Musculoskeletal Chest Pain  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Musculoskeletal Discomfort  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Musculoskeletal Pain  1  3/25 (12.00%)  4 2/27 (7.41%)  2
Musculoskeletal Stiffness  1  0/25 (0.00%)  0 2/27 (7.41%)  2
Myalgia  1  2/25 (8.00%)  5 3/27 (11.11%)  3
Neck Pain  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Pain in Extremity  1  1/25 (4.00%)  1 3/27 (11.11%)  3
Pain in Jaw  1  2/25 (8.00%)  2 0/27 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal Cell Carcinoma  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Hair Follicle Tumour Benign  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Melanocytic Naevus  1  0/25 (0.00%)  0 2/27 (7.41%)  2
Seborrhoetic Keratosis  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Nervous system disorders     
Ageusia  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Altered State of Consciousness  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Amnesia  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Coordination Abnormal  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Disturbance in Attention  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Dizziness  1  4/25 (16.00%)  5 6/27 (22.22%)  9
Dysaesthesia  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Dysarthria  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Headache  1  3/25 (12.00%)  4 4/27 (14.81%)  4
Hypoaesthesia  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Lethargy  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Neuralgia  1  0/25 (0.00%)  0 2/27 (7.41%)  2
Paraesthesia  1  3/25 (12.00%)  4 5/27 (18.52%)  6
Paralysis  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Presyncope  1  2/25 (8.00%)  2 2/27 (7.41%)  2
Tremor  1  0/25 (0.00%)  0 2/27 (7.41%)  2
Psychiatric disorders     
Anxiety  1  4/25 (16.00%)  4 1/27 (3.70%)  1
Confusional State  1  1/25 (4.00%)  1 1/27 (3.70%)  1
Depression  1  2/25 (8.00%)  2 2/27 (7.41%)  2
Insomnia  1  3/25 (12.00%)  3 2/27 (7.41%)  2
Restlessness  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Sleep Disorder  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Renal and urinary disorders     
Bladder Outlet Obstruction  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Dysuria  1  1/25 (4.00%)  1 1/27 (3.70%)  1
Haematuria  1  1/25 (4.00%)  1 2/27 (7.41%)  2
Nocturia  1  3/25 (12.00%)  3 0/27 (0.00%)  0
Renal Failure Chronic  1  0/25 (0.00%)  0 2/27 (7.41%)  2
Ureteric Obstruction  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Urinary Hesitation  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Urinary Incontinence  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Urinary Retention  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Urinary Tract Obstruction  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Reproductive system and breast disorders     
Gynaecomastia  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic Obstruction Pulmonary  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Cough  1  2/25 (8.00%)  2 6/27 (22.22%)  6
Dyspnoea  1  2/25 (8.00%)  2 1/27 (3.70%)  1
Dyspnoea Exertional  1  2/25 (8.00%)  2 0/27 (0.00%)  0
Epistaxis  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Nasal Congestion  1  0/25 (0.00%)  0 3/27 (11.11%)  3
Oroparyngeal Pain  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Orthopnoea  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Productive Cough  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Pulmonary Congestion  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Sinus Congestion  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Sneezing  1  0/25 (0.00%)  0 2/27 (7.41%)  2
Upper-Airway Cough Syndrome  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Wheezing  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Skin and subcutaneous tissue disorders     
Cold Sweat  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Erythema  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Hyperhidrosis  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Rash  1  2/25 (8.00%)  2 1/27 (3.70%)  1
Rash Maculo-Papular  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Skin Exfoliation  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Skin Lesion  1  2/25 (8.00%)  2 0/27 (0.00%)  0
Surgical and medical procedures     
Cyst Drainage  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Vascular disorders     
Flushing  1  1/25 (4.00%)  1 0/27 (0.00%)  0
Hot Flush  1  3/25 (12.00%)  3 5/27 (18.52%)  5
Hypertension  1  2/25 (8.00%)  2 2/27 (7.41%)  3
Hypotension  1  3/25 (12.00%)  4 1/27 (3.70%)  1
Pallor  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Peripheral Coldness  1  0/25 (0.00%)  0 1/27 (3.70%)  1
Phlebitis  1  1/25 (4.00%)  1 0/27 (0.00%)  0
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
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 results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shabnam Vaziri
Organization: Dendreon
Phone: 206.455.2323
EMail: svaziri@Dendreon.com
Layout table for additonal information
Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01981122    
Other Study ID Numbers: P12-2
First Submitted: October 29, 2013
First Posted: November 11, 2013
Results First Submitted: July 24, 2018
Results First Posted: September 25, 2018
Last Update Posted: October 24, 2018