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Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

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: NCT00005947
Recruitment Status : Completed
First Posted : March 5, 2004
Results First Posted : November 1, 2010
Last Update Posted : November 1, 2010
Sponsor:
Information provided by:
Dendreon

Study Type Interventional
Study Design Allocation: Randomized;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Biological: sipuleucel-T
Biological: Placebo
Enrollment 127
Recruitment Details Participants were randomized between January 2000 and September 2004 across 16 clinical trial sites.
Pre-assignment Details Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
Arm/Group Title Sipuleucel-T Placebo
Hide Arm/Group Description

All subjects randomized to receive sipuleucel-T.

Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.

All subjects randomized to receive placebo.

Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

Period Title: Overall Study
Started 82 45
Completed 25 4
Not Completed 57 41
Reason Not Completed
Death             54             40
Patient Refused to Continue             2             1
Site Closure             1             0
Arm/Group Title Sipuleucel-T Placebo Total
Hide Arm/Group Description All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart. All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Total of all reporting groups
Overall Number of Baseline Participants 82 45 127
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 45 participants 127 participants
72.1  (8.1) 71.1  (8.3) 71.7  (8.1)
Age, Customized  
Median (Full Range)
Unit of measure:  Years (Min, Max)
Number Analyzed 82 participants 45 participants 127 participants
73.0
(47 to 85)
71.0
(50 to 86)
73.0
(47 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 45 participants 127 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
82
 100.0%
45
 100.0%
127
 100.0%
1.Primary Outcome
Title Time to Objective Disease Progression
Hide Description The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).
Time Frame 36 months from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized participants
Arm/Group Title Sipuleucel-T Placebo
Hide Arm/Group Description:
All subjects randomized to receive sipuleucel-T.
All subjects randomized to receive placebo
Overall Number of Participants Analyzed 82 45
Median (95% Confidence Interval)
Unit of Measure: Weeks
11.7
(9.1 to 16.6)
10.0
(8.7 to 13.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sipuleucel-T, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.45
Confidence Interval 95%
0.99 to 2.11
Estimation Comments Obtained from a Cox proportional hazards model with treatment group as the independent variable [placebo/sipuleucel-T].
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sipuleucel-T, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.47 to 1.01
Estimation Comments Obtained from a Cox proportional hazards model with treatment group as the independent variable [sipuleucel-T/placebo]
2.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival
Time Frame From randomization to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sipuleucel-T Placebo
Hide Arm/Group Description:
All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
Overall Number of Participants Analyzed 82 45
Median (95% Confidence Interval)
Unit of Measure: Months
25.9
(20.0 to 32.4)
21.4
(12.3 to 25.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sipuleucel-T, Placebo
Comments ITT Population - all randomized participants
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.71
Confidence Interval 95%
1.13 to 2.58
Estimation Comments Cox proportional hazards model with treatment as the independent variable [placebo/sipuleucel-T].
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sipuleucel-T, Placebo
Comments ITT Population - all randomized participants.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.586
Confidence Interval (2-Sided) 95%
0.388 to 0.884
Estimation Comments Cox proportional hazards model with treatment as the independent variable [sipuleucel-T/placebo]
Time Frame 4 years, 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sipuleucel-T Placebo
Hide Arm/Group Description All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart. All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
All-Cause Mortality
Sipuleucel-T Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Sipuleucel-T Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   22/82 (26.83%)   8/45 (17.78%) 
Blood and lymphatic system disorders     
Anaemia  1  1/82 (1.22%)  0/45 (0.00%) 
Cardiac disorders     
Aortic valve incompetence  1  0/82 (0.00%)  1/45 (2.22%) 
Arrhythmia  1  0/82 (0.00%)  1/45 (2.22%) 
Atrial fibrillation  1  1/82 (1.22%)  0/45 (0.00%) 
Atrioventricular block  1  0/82 (0.00%)  1/45 (2.22%) 
Cardiac failure congestive  1  1/82 (1.22%)  0/45 (0.00%) 
Myocardial infarction  1  1/82 (1.22%)  0/45 (0.00%) 
Eye disorders     
Retinal detachment  1  1/82 (1.22%)  0/45 (0.00%) 
Gastrointestinal disorders     
Faecaloma  1  0/82 (0.00%)  1/45 (2.22%) 
General disorders     
Chest pain  1  1/82 (1.22%)  0/45 (0.00%) 
Chills  1  2/82 (2.44%)  0/45 (0.00%) 
Gait disturbance  1  1/82 (1.22%)  0/45 (0.00%) 
Pain  1  0/82 (0.00%)  1/45 (2.22%) 
Pyrexia  1  2/82 (2.44%)  0/45 (0.00%) 
Infections and infestations     
Bacteraemia  1  0/82 (0.00%)  1/45 (2.22%) 
Catheter related infection  1  1/82 (1.22%)  0/45 (0.00%) 
Catheter sepsis  1  1/82 (1.22%)  0/45 (0.00%) 
Sepsis  1  1/82 (1.22%)  0/45 (0.00%) 
Urinary tract infection  1  1/82 (1.22%)  0/45 (0.00%) 
Investigations     
Blood creatinine increased  1  1/82 (1.22%)  0/45 (0.00%) 
Heart rate irregular  1  0/82 (0.00%)  1/45 (2.22%) 
Transaminases increased  1  1/82 (1.22%)  0/45 (0.00%) 
White blood cell count increased  1  1/82 (1.22%)  0/45 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/82 (1.22%)  1/45 (2.22%) 
Hypokalaemia  1  1/82 (1.22%)  0/45 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/82 (1.22%)  0/45 (0.00%) 
Chest wall pain  1  1/82 (1.22%)  0/45 (0.00%) 
Pain in extremity  1  1/82 (1.22%)  0/45 (0.00%) 
Pathological fracture  1  1/82 (1.22%)  0/45 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Glioblastoma  1  1/82 (1.22%)  0/45 (0.00%) 
Nervous system disorders     
Aphasia  1  1/82 (1.22%)  0/45 (0.00%) 
Cerebrovascular accident  1  2/82 (2.44%)  0/45 (0.00%) 
Haemorrhage intracranial  1  1/82 (1.22%)  0/45 (0.00%) 
Lumbar radiculopathy  1  1/82 (1.22%)  0/45 (0.00%) 
Spinal cord compression  1  2/82 (2.44%)  0/45 (0.00%) 
Syncope  1  1/82 (1.22%)  0/45 (0.00%) 
Transient ischaemic attack  1  1/82 (1.22%)  0/45 (0.00%) 
Renal and urinary disorders     
Bladder Obstruction  1  0/82 (0.00%)  1/45 (2.22%) 
Haematuria  1  1/82 (1.22%)  2/45 (4.44%) 
Hydronephrosis  1  0/82 (0.00%)  1/45 (2.22%) 
Renal failure  1  0/82 (0.00%)  1/45 (2.22%) 
Urinary retention  1  2/82 (2.44%)  2/45 (4.44%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  3/82 (3.66%)  1/45 (2.22%) 
Hypoxia  1  1/82 (1.22%)  0/45 (0.00%) 
Pleural effusion  1  1/82 (1.22%)  0/45 (0.00%) 
Pleuritic pain  1  1/82 (1.22%)  0/45 (0.00%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  1/82 (1.22%)  0/45 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sipuleucel-T Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   82/82 (100.00%)   44/45 (97.78%) 
Blood and lymphatic system disorders     
Anaemia  1  7/82 (8.54%)  7/45 (15.56%) 
Gastrointestinal disorders     
Constipation  1  9/82 (10.98%)  7/45 (15.56%) 
Diarrhoea  1  6/82 (7.32%)  5/45 (11.11%) 
Dyspepsia  1  4/82 (4.88%)  3/45 (6.67%) 
Nausea  1  12/82 (14.63%)  5/45 (11.11%) 
Vomiting  1  10/82 (12.20%)  1/45 (2.22%) 
General disorders     
Asthenia  1  9/82 (10.98%)  1/45 (2.22%) 
Chills  1  51/82 (62.20%)  4/45 (8.89%) 
Fatigue  1  36/82 (43.90%)  17/45 (37.78%) 
Feeling cold  1  8/82 (9.76%)  1/45 (2.22%) 
Influenza like illness  1  5/82 (6.10%)  1/45 (2.22%) 
Oedema peripheral  1  6/82 (7.32%)  5/45 (11.11%) 
Pain  1  5/82 (6.10%)  5/45 (11.11%) 
Pyrexia  1  28/82 (34.15%)  2/45 (4.44%) 
Infections and infestations     
Upper respiratory tract infection  1  6/82 (7.32%)  2/45 (4.44%) 
Injury, poisoning and procedural complications     
Contusion  1  1/82 (1.22%)  3/45 (6.67%) 
Investigations     
Weight decreased  1  6/82 (7.32%)  2/45 (4.44%) 
Metabolism and nutrition disorders     
Anorexia  1  7/82 (8.54%)  5/45 (11.11%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  12/82 (14.63%)  5/45 (11.11%) 
Back pain  1  18/82 (21.95%)  10/45 (22.22%) 
Chest wall pain  1  9/82 (10.98%)  4/45 (8.89%) 
Groin pain  1  5/82 (6.10%)  1/45 (2.22%) 
Muscle spasms  1  5/82 (6.10%)  4/45 (8.89%) 
Myalgia  1  7/82 (8.54%)  2/45 (4.44%) 
Neck pain  1  5/82 (6.10%)  1/45 (2.22%) 
Pain in extremity  1  7/82 (8.54%)  5/45 (11.11%) 
Shoulder pain  1  6/82 (7.32%)  2/45 (4.44%) 
Nervous system disorders     
Headache  1  14/82 (17.07%)  1/45 (2.22%) 
Paraesthesia  1  13/82 (15.85%)  2/45 (4.44%) 
Tremor  1  8/82 (9.76%)  0/45 (0.00%) 
Psychiatric disorders     
Insomnia  1  1/82 (1.22%)  4/45 (8.89%) 
Renal and urinary disorders     
Dysuria  1  2/82 (2.44%)  4/45 (8.89%) 
Haematuria  1  5/82 (6.10%)  3/45 (6.67%) 
Pollakiuria  1  1/82 (1.22%)  4/45 (8.89%) 
Urinary retention  1  4/82 (4.88%)  4/45 (8.89%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/82 (4.88%)  5/45 (11.11%) 
Dyspnoea  1  14/82 (17.07%)  2/45 (4.44%) 
Vascular disorders     
Flushing  1  2/82 (2.44%)  3/45 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
A provision provides for sponsor review up to 45 days with the right to request modification based on disclosure of confidential information; extendable by 60 days to file a patent application.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathleen Picha
Organization: Dendreon Corporation
Phone: 206-274-6762
EMail: kpicha@dendreon.com
Layout table for additonal information
Responsible Party: Elizabeth Smith, Dendreon Corporation
ClinicalTrials.gov Identifier: NCT00005947    
Other Study ID Numbers: D9901 CDR0000067868
DEN-D9901
NCI-G00-1789
First Submitted: July 5, 2000
First Posted: March 5, 2004
Results First Submitted: May 28, 2010
Results First Posted: November 1, 2010
Last Update Posted: November 1, 2010