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Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory 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: NCT01133704
Recruitment Status : Completed
First Posted : May 31, 2010
Results First Posted : September 2, 2010
Last Update Posted : September 8, 2010
Sponsor:
Information provided by:
Dendreon

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hormone-Refractory Prostate Cancer
Interventions Biological: sipuleucel-T
Biological: APC-Placebo
Enrollment 98
Recruitment Details Participants were randomized between May 2000 and March 2003 across 24 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 (APC8015) 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 65 33
Completed 16 [1] 7 [1]
Not Completed 49 26
Reason Not Completed
Death             44             26
Patient refused to continue             4             0
Study Closure             1             0
[1]
(including 3 year follow-up)
Arm/Group Title Sipuleucel-T (APC8015) 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 autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

Total of all reporting groups
Overall Number of Baseline Participants 65 33 98
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 33 participants 98 participants
69.6  (8.2) 70.6  (7.8) 69.9  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 33 participants 98 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
65
 100.0%
33
 100.0%
98
 100.0%
1.Primary Outcome
Title Overall Time to Disease Progression
Hide Description Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.
Time Frame from randomization to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sipuleucel-T (APC8015) 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.

Overall Number of Participants Analyzed 65 33
Median (95% Confidence Interval)
Unit of Measure: Weeks
10.9
(9.3 to 17.7)
9.9
(8.4 to 18.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sipuleucel-T (APC8015), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.719
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.69 to 1.70
Estimation Comments Obtained from a Cox proportional hazards model with treatment group as the independent variable, stratified by bisphosphonate use (placebo/sipuleucel-T)
2.Secondary Outcome
Title Overall Survival
Hide Description Subjects were followed for 3 years from the time of randomization or until death.
Time Frame Time from randomization until 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Sipuleucel-T (APC8015) 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.

Overall Number of Participants Analyzed 65 33
Median (95% Confidence Interval)
Unit of Measure: Months
19.0
(13.6 to 31.9)
15.7
(12.8 to 25.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sipuleucel-T (APC8015), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.331
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.78 to 2.07
Estimation Comments Obtained from a Cox proportional hazards model with treatment as the independent variable, and stratified by bisphosphonate use (placebo/sipuleucel-T).
Time Frame From randomization through 36 months. Median follow-up was 36 months.
Adverse Event Reporting Description Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
 
Arm/Group Title Sipuleucel-T (APC8015) 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.

All-Cause Mortality
Sipuleucel-T (APC8015) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Sipuleucel-T (APC8015) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/65 (20.00%)   9/31 (29.03%) 
Blood and lymphatic system disorders     
Anaemia  1  1/65 (1.54%)  1/31 (3.23%) 
Disseminated intravascular coagulation  1  1/65 (1.54%)  0/31 (0.00%) 
Cardiac disorders     
Atrial flutter  1  1/65 (1.54%)  0/31 (0.00%) 
Cardiac failure  1  1/65 (1.54%)  0/31 (0.00%) 
Cardiac failure congestive  1  0/65 (0.00%)  1/31 (3.23%) 
Supraventricular tachycardia  1  0/65 (0.00%)  1/31 (3.23%) 
Tachycardia  1  1/65 (1.54%)  0/31 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/65 (0.00%)  1/31 (3.23%) 
Intestinal obstruction  1  0/65 (0.00%)  1/31 (3.23%) 
Nausea  1  1/65 (1.54%)  0/31 (0.00%) 
General disorders     
Adverse drug reaction  1  1/65 (1.54%)  0/31 (0.00%) 
Chills  1  3/65 (4.62%)  0/31 (0.00%) 
Disease Progression  1  1/65 (1.54%)  0/31 (0.00%) 
Pain  1  1/65 (1.54%)  0/31 (0.00%) 
Pyrexia  1  2/65 (3.08%)  0/31 (0.00%) 
Infections and infestations     
Bacteraemia  1  1/65 (1.54%)  0/31 (0.00%) 
Bacterial sepsis  1  1/65 (1.54%)  0/31 (0.00%) 
Catheter sepsis  1  1/65 (1.54%)  0/31 (0.00%) 
Cellulitis  1  0/65 (0.00%)  1/31 (3.23%) 
Extradural abscess  1  1/65 (1.54%)  0/31 (0.00%) 
Sepsis  1  1/65 (1.54%)  1/31 (3.23%) 
Staphylococcal bacteraemia  1  1/65 (1.54%)  0/31 (0.00%) 
Staphylococcal sepsis  1  1/65 (1.54%)  0/31 (0.00%) 
Urinary tract infection  1  1/65 (1.54%)  0/31 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  2/65 (3.08%)  1/31 (3.23%) 
Hyperglycaemia  1  0/65 (0.00%)  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  1/65 (1.54%)  1/31 (3.23%) 
Chest wall pain  1  1/65 (1.54%)  0/31 (0.00%) 
Pathological fracture  1  0/65 (0.00%)  1/31 (3.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to spine  1  1/65 (1.54%)  0/31 (0.00%) 
Skin cancer  1  0/65 (0.00%)  1/31 (3.23%) 
Small cell lung cancer stage unspecified  1  0/65 (0.00%)  1/31 (3.23%) 
Nervous system disorders     
Brain mass  1  1/65 (1.54%)  0/31 (0.00%) 
Cerebral haemorrhage  1  1/65 (1.54%)  0/31 (0.00%) 
Cerebrovascular accident  1  1/65 (1.54%)  0/31 (0.00%) 
Facial palsy  1  1/65 (1.54%)  0/31 (0.00%) 
Headache  1  1/65 (1.54%)  0/31 (0.00%) 
Lacunar infarction  1  1/65 (1.54%)  0/31 (0.00%) 
Paraesthesia  1  1/65 (1.54%)  0/31 (0.00%) 
Renal and urinary disorders     
Haematuria  1  1/65 (1.54%)  0/31 (0.00%) 
Urinary retention  1  0/65 (0.00%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/65 (1.54%)  0/31 (0.00%) 
Pulmonary embolism  1  0/65 (0.00%)  1/31 (3.23%) 
Vascular disorders     
Deep vein thrombosis  1  0/65 (0.00%)  2/31 (6.45%) 
Embolism  1  0/65 (0.00%)  1/31 (3.23%) 
Hypertension  1  2/65 (3.08%)  0/31 (0.00%) 
Hypotension  1  0/65 (0.00%)  1/31 (3.23%) 
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 (APC8015) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   63/65 (96.92%)   29/31 (93.55%) 
Blood and lymphatic system disorders     
Anaemia  1  13/65 (20.00%)  1/31 (3.23%) 
Gastrointestinal disorders     
Constipation  1  5/65 (7.69%)  4/31 (12.90%) 
Diarrhoea  1  4/65 (6.15%)  2/31 (6.45%) 
Dyspepsia  1  1/65 (1.54%)  2/31 (6.45%) 
Hypoaesthesia Oral  1  4/65 (6.15%)  1/31 (3.23%) 
Nausea  1  9/65 (13.85%)  1/31 (3.23%) 
Vomiting  1  6/65 (9.23%)  1/31 (3.23%) 
General disorders     
Asthenia  1  12/65 (18.46%)  2/31 (6.45%) 
Chills  1  34/65 (52.31%)  2/31 (6.45%) 
Fatigue  1  27/65 (41.54%)  5/31 (16.13%) 
Influenza Like Illness  1  4/65 (6.15%)  2/31 (6.45%) 
Malaise  1  4/65 (6.15%)  0/31 (0.00%) 
Oedema Peripheral  1  7/65 (10.77%)  5/31 (16.13%) 
Pain  1  9/65 (13.85%)  2/31 (6.45%) 
Pyrexia  1  19/65 (29.23%)  3/31 (9.68%) 
Injury, poisoning and procedural complications     
Citrate Toxicity  1  10/65 (15.38%)  5/31 (16.13%) 
Metabolism and nutrition disorders     
Anorexia  1  6/65 (9.23%)  1/31 (3.23%) 
Dehydration  1  4/65 (6.15%)  1/31 (3.23%) 
Hyperglycemia  1  0/65 (0.00%)  2/31 (6.45%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  10/65 (15.38%)  9/31 (29.03%) 
Back Pain  1  14/65 (21.54%)  8/31 (25.81%) 
Bone Pain  1  0/65 (0.00%)  2/31 (6.45%) 
Chest Wall Pain  1  7/65 (10.77%)  1/31 (3.23%) 
Groin Pain  1  0/65 (0.00%)  2/31 (6.45%) 
Myalgia  1  5/65 (7.69%)  2/31 (6.45%) 
Neck Pain  1  2/65 (3.08%)  2/31 (6.45%) 
Pain in Extremity  1  7/65 (10.77%)  7/31 (22.58%) 
Shoulder Pain  1  3/65 (4.62%)  3/31 (9.68%) 
Nervous system disorders     
Dizziness  1  8/65 (12.31%)  2/31 (6.45%) 
Headache  1  14/65 (21.54%)  3/31 (9.68%) 
Lethargy  1  0/65 (0.00%)  2/31 (6.45%) 
Paraesthesia  1  6/65 (9.23%)  5/31 (16.13%) 
Paraesthesia Oral  1  5/65 (7.69%)  3/31 (9.68%) 
Tremor  1  5/65 (7.69%)  0/31 (0.00%) 
Psychiatric disorders     
Insomnia  1  1/65 (1.54%)  4/31 (12.90%) 
Renal and urinary disorders     
Urinary Retention  1  3/65 (4.62%)  2/31 (6.45%) 
Reproductive system and breast disorders     
Gynaecomastia  1  2/65 (3.08%)  2/31 (6.45%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/65 (6.15%)  1/31 (3.23%) 
Dyspnoea Exertional  1  3/65 (4.62%)  2/31 (6.45%) 
Vascular disorders     
Deep Vein Thrombosis  1  0/65 (0.00%)  2/31 (6.45%) 
Hypertension  1  5/65 (7.69%)  0/31 (0.00%) 
Pallor  1  7/65 (10.77%)  3/31 (9.68%) 
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: 206-265-4545
EMail: kpicha@dendreon.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT01133704    
Other Study ID Numbers: D9902A
First Submitted: May 27, 2010
First Posted: May 31, 2010
Results First Submitted: June 1, 2010
Results First Posted: September 2, 2010
Last Update Posted: September 8, 2010