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A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer (PROCEED)

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: NCT01306890
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Dendreon

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Advanced Prostate Cancer
Prostatic Neoplasms
Intervention Biological: sipuleucel-T
Enrollment 1976
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sipuleucel-T
Hide Arm/Group Description sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Period Title: Overall Study
Started 1976
Completed 457 [1]
Not Completed 1519
Reason Not Completed
Adverse Event             2
Death             1223
Lost to Follow-up             58
Withdrawal by Subject             88
Unspecified reasons             104
Study Termination             3
No discontinuation documentation             41
[1]
Subjects were alive at the end of the study and had completed at least 3 years of follow up.
Arm/Group Title Sipuleucel-T
Hide Arm/Group Description sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Overall Number of Baseline Participants 1902
Hide Baseline Analysis Population Description
The analysis population only includes subjects that received at least one partial infusion of Sip-T.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1902 participants
<=18 years
0
   0.0%
Between 18 and 65 years
441
  23.2%
>=65 years
1461
  76.8%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1902 participants
71.9
(42 to 97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1902 participants
Female
0
   0.0%
Male
1902
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1902 participants
American Indian or Alaska Native
6
   0.3%
Asian
22
   1.2%
Native Hawaiian or Other Pacific Islander
4
   0.2%
Black or African American
221
  11.6%
White
1649
  86.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1902 participants
1902
 100.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 1902 participants
91.97  (17.67)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 1902 participants
176.59  (7.29)
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1902 participants
ECOG 0=Fully Active; No restrictions
1265
  66.5%
ECOG 1= Restricted Strenuous Activity
571
  30.0%
ECOG 2= Capable of selfcare
34
   1.8%
ECOG 3= Capable of limited selfcare
8
   0.4%
ECOG Not Reported
24
   1.3%
[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
Primary Gleason Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1902 participants
Gleason Score ≤3
486
  25.6%
Gleason Score ≥4
1145
  60.2%
Primary Gleason Score Data Not Recorded
271
  14.2%
[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.
Gleason Sum Reported   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1902 participants
Gleason Score ≤7
790
  41.5%
Gleason Score ≥8
963
  50.6%
Gleson Sum Data Not Recorded
149
   7.8%
[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.
Comorbidity Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1902 participants
High
220
  11.6%
Low
1682
  88.4%
[1]
Measure Description: The NCI Comorbidity Index was used for this study. It is a weighted index to predict risk of death within 1 year of hospitalization for patients with specific comorbid conditions. Nineteen conditions were included in the index. Each condition was assigned a weight from 1 to 6, based on the estimated 1-year mortality hazard ratio from a Cox proportional hazards model. These weights were summed and for this study, a score of 0-1 was classified as a LOW score and a score great than 2 was classified as a HIGH score.
Alkaline phosphatase  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 1902 participants
117.8  (163.2)
Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 1902 participants
12.68  (1.48)
Lactate dehydrogenase  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 1902 participants
225.1  (211.6)
Prostate-specific antigen (PSA)  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 1902 participants
71.93  (287.89)
1.Primary Outcome
Title To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects
Hide Description The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.
Time Frame Every 3 months for a minimum of 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sipuleucel-T
Hide Arm/Group Description:
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Overall Number of Participants Analyzed 1902
Measure Type: Number
Unit of Measure: events per 100 patient years
1.2
2.Secondary Outcome
Title Survival
Hide Description To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.
Time Frame Every 3 months for a minimum of 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sipuleucel-T
Hide Arm/Group Description:
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Overall Number of Participants Analyzed 1902
Median (95% Confidence Interval)
Unit of Measure: months
30.7
(28.6 to 32.2)
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 Sipuleucel-T
Hide Arm/Group Description sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
All-Cause Mortality
Sipuleucel-T
Affected / at Risk (%)
Total   1223/1976 (61.89%)    
Hide Serious Adverse Events
Sipuleucel-T
Affected / at Risk (%) # Events
Total   260/1902 (13.67%)    
Blood and lymphatic system disorders   
Anaemia * 1  7/1902 (0.37%)  14
Disseminated intravascular coagulation * 1  1/1902 (0.05%)  2
Febrile neutropenia * 1  1/1902 (0.05%)  1
Leukocytosis * 1  1/1902 (0.05%)  2
Microcytic anaemia * 1  1/1902 (0.05%)  1
Retroperitoneal lymphadenopathy * 1  1/1902 (0.05%)  1
Thrombocytopenia * 1  1/1902 (0.05%)  1
Cardiac disorders   
Acute myocardial infarction * 1  2/1902 (0.11%)  3
Angina unstable * 1  1/1902 (0.05%)  1
Atrial fibrillation * 1  3/1902 (0.16%)  8
Cardiac failure congestive * 1  4/1902 (0.21%)  7
Cardio-respiratory arrest * 1  2/1902 (0.11%)  2
Myocardial infarction * 1  6/1902 (0.32%)  7
Sinus bradycardia * 1  1/1902 (0.05%)  1
Supraventricular tachycardia * 1  1/1902 (0.05%)  1
Tachycardia * 1  1/1902 (0.05%)  1
Ventricular tachycardia * 1  1/1902 (0.05%)  1
Eye disorders   
Papilloedema * 1  1/1902 (0.05%)  1
Gastrointestinal disorders   
Colitis * 1  1/1902 (0.05%)  1
Abdominal pain * 1  1/1902 (0.05%)  3
Colonic pseudo-obstruction * 1  1/1902 (0.05%)  1
Constipation * 1  3/1902 (0.16%)  3
Diarrhoea * 1  1/1902 (0.05%)  1
Duodenal ulcer * 1  1/1902 (0.05%)  1
Gastric haemorrhage * 1  1/1902 (0.05%)  2
Hiatus hernia * 1  1/1902 (0.05%)  1
Intestinal obstruction * 1  2/1902 (0.11%)  2
Intestinal perforation * 1  1/1902 (0.05%)  1
Intestinal ulcer * 1  1/1902 (0.05%)  1
Nausea * 1  4/1902 (0.21%)  10
Pancreatitis * 1  1/1902 (0.05%)  1
Upper gastrointestinal haemorrhage * 1  1/1902 (0.05%)  1
Vomiting * 1  4/1902 (0.21%)  8
General disorders   
Asthenia * 1  3/1902 (0.16%)  6
Chest pain * 1  6/1902 (0.32%)  8
Chills * 1  13/1902 (0.68%)  18
Death * 1  1/1902 (0.05%)  2
Disease progression * 1  28/1902 (1.47%)  37
Gait disturbance * 1  1/1902 (0.05%)  1
Impaired healing * 1  1/1902 (0.05%)  1
Pain * 1  1/1902 (0.05%)  3
Pyrexia * 1  6/1902 (0.32%)  10
Hepatobiliary disorders   
Hepatic failure * 1  2/1902 (0.11%)  2
Jaundice * 1  1/1902 (0.05%)  1
Infections and infestations   
Bacteraemia * 1  3/1902 (0.16%)  3
Bacterial infection * 1  1/1902 (0.05%)  1
Bronchitis * 1  2/1902 (0.11%)  2
Clostridium difficile colitis * 1  1/1902 (0.05%)  2
Device related infection * 1  10/1902 (0.53%)  10
Device related sepsis * 1  4/1902 (0.21%)  4
Endocarditis staphylococcal * 1  1/1902 (0.05%)  1
Infection * 1  2/1902 (0.11%)  2
Intervertebral discitis * 1  1/1902 (0.05%)  1
Ludwig angina * 1  1/1902 (0.05%)  1
Osteomyelitis * 1  1/1902 (0.05%)  2
Otitis media acute * 1  1/1902 (0.05%)  1
Pneumococcal bacteraemia * 1  1/1902 (0.05%)  1
Pneumonia * 1  5/1902 (0.26%)  7
Salmonella sepsis * 1  1/1902 (0.05%)  1
Sepsis * 1  2/1902 (0.11%)  5
Septic shock * 1  1/1902 (0.05%)  1
Staphylococcal bacteraemia * 1  1/1902 (0.05%)  1
Tooth abscess * 1  1/1902 (0.05%)  1
Upper respiratory tract infection * 1  1/1902 (0.05%)  1
Urinary tract infection * 1  2/1902 (0.11%)  8
Urinary tract infection staphylococcal * 1  1/1902 (0.05%)  1
Injury, poisoning and procedural complications   
Cystitis radiation * 1  1/1902 (0.05%)  1
Fall * 1  3/1902 (0.16%)  8
Femur fracture * 1  1/1902 (0.05%)  1
Head injury * 1  1/1902 (0.05%)  1
Hip fracture * 1  1/1902 (0.05%)  1
Infusion related reaction * 1  3/1902 (0.16%)  4
Joint dislocation * 1  1/1902 (0.05%)  1
Laceration * 1  2/1902 (0.11%)  2
Ligament sprain * 1  1/1902 (0.05%)  1
Post concussion syndrome * 1  1/1902 (0.05%)  1
Skull fracture * 1  1/1902 (0.05%)  1
Spinal compression fracture * 1  1/1902 (0.05%)  1
Spinal fracture * 1  1/1902 (0.05%)  1
Subdural haematoma * 1  6/1902 (0.32%)  13
Traumatic intracranial haemorrhage * 1  1/1902 (0.05%)  2
Investigations   
Blood potassium increased * 1  1/1902 (0.05%)  1
Blood pressure decreased * 1  1/1902 (0.05%)  1
Blood pressure increased * 1  1/1902 (0.05%)  2
Haemoglobin decreased * 1  1/1902 (0.05%)  1
Oxygen saturation decreased * 1  1/1902 (0.05%)  1
Troponin increased * 1  1/1902 (0.05%)  1
White blood cell count increased * 1  1/1902 (0.05%)  1
Metabolism and nutrition disorders   
Dehydration * 1  4/1902 (0.21%)  11
Failure to thrive * 1  1/1902 (0.05%)  1
Hyperkalaemia * 1  2/1902 (0.11%)  2
Hypocalcaemia * 1  1/1902 (0.05%)  1
Hypoglycaemia * 1  1/1902 (0.05%)  1
Hypokalaemia * 1  1/1902 (0.05%)  2
Hyponatraemia * 1  1/1902 (0.05%)  4
Hypovolaemia * 1  2/1902 (0.11%)  2
Malnutrition * 1  1/1902 (0.05%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  3/1902 (0.16%)  7
Flank pain * 1  1/1902 (0.05%)  1
Musculoskeletal pain * 1  2/1902 (0.11%)  2
Neck pain * 1  1/1902 (0.05%)  2
Pain in extremity * 1  1/1902 (0.05%)  1
Pathological fracture * 1  1/1902 (0.05%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to central nervous system * 1  1/1902 (0.05%)  1
Prostate cancer metastatic * 1  2/1902 (0.11%)  2
Prostate cancer stage IV * 1  1/1902 (0.05%)  1
Nervous system disorders   
Cauda equina syndrome * 1  2/1902 (0.11%)  2
Central nervous system haemorrhage * 1  1/1902 (0.05%)  1
Cerebral haemorrhage * 1  5/1902 (0.26%)  6
Cerebral infarction * 1  4/1902 (0.21%)  5
Cerebrovascular accident * 1  16/1902 (0.84%)  20
Dizziness * 1  1/1902 (0.05%)  1
Dysarthria * 1  1/1902 (0.05%)  1
Embolic stroke * 1  2/1902 (0.11%)  2
Encephalopathy * 1  1/1902 (0.05%)  2
Haemorrhage intracranial * 1  4/1902 (0.21%)  4
Haemorrhagic stroke * 1  1/1902 (0.05%)  1
Headache * 1  2/1902 (0.11%)  2
Hemiparesis * 1  1/1902 (0.05%)  1
Hemiplegia * 1  1/1902 (0.05%)  1
Hydrocephalus * 1  1/1902 (0.05%)  1
Hydromyelia * 1  1/1902 (0.05%)  1
Intracranial mass * 1  1/1902 (0.05%)  1
Ischaemic stroke * 1  2/1902 (0.11%)  2
Lacunar infarction * 1  1/1902 (0.05%)  1
Lethargy * 1  1/1902 (0.05%)  1
Paralysis * 1  1/1902 (0.05%)  1
Partial seizures * 1  1/1902 (0.05%)  1
Peroneal nerve palsy * 1  1/1902 (0.05%)  1
Presyncope * 1  3/1902 (0.16%)  3
Seizure * 1  1/1902 (0.05%)  1
Spinal cord compression * 1  4/1902 (0.21%)  4
Subarachnoid haemorrhage * 1  1/1902 (0.05%)  3
Syncope * 1  12/1902 (0.63%)  12
Thalamic infarction * 1  1/1902 (0.05%)  1
Transient ischaemic attack * 1  6/1902 (0.32%)  7
Psychiatric disorders   
Acute psychosis * 1  1/1902 (0.05%)  1
Anxiety * 1  1/1902 (0.05%)  1
Confusional state * 1  3/1902 (0.16%)  5
Depression * 1  2/1902 (0.11%)  2
Mental status changes * 1  1/1902 (0.05%)  2
Renal and urinary disorders   
Acute kidney injury * 1  8/1902 (0.42%)  13
Bladder obstruction * 1  1/1902 (0.05%)  1
Haematuria * 1  3/1902 (0.16%)  5
Hydronephrosis * 1  1/1902 (0.05%)  2
Nephropathy * 1  1/1902 (0.05%)  1
Obstructive uropathy * 1  1/1902 (0.05%)  1
Renal failure * 1  2/1902 (0.11%)  3
Renal injury * 1  1/1902 (0.05%)  1
Ureteric obstruction * 1  1/1902 (0.05%)  3
Urethral stenosis * 1  1/1902 (0.05%)  1
Urinary retention * 1  1/1902 (0.05%)  2
Prostatomegaly * 1  1/1902 (0.05%)  1
Reproductive system and breast disorders   
Cough * 1  1/1902 (0.05%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure * 1  1/1902 (0.05%)  1
Chronic obstructive pulmonary disease * 1  1/1902 (0.05%)  1
Dyspnoea * 1  7/1902 (0.37%)  10
Haemothorax * 1  1/1902 (0.05%)  1
Pleural effusion * 1  1/1902 (0.05%)  2
Pneumonia aspiration * 1  1/1902 (0.05%)  1
Pulmonary embolism * 1  8/1902 (0.42%)  11
Respiratory arrest * 1  1/1902 (0.05%)  1
Respiratory failure * 1  1/1902 (0.05%)  1
Sleep apnoea syndrome * 1  1/1902 (0.05%)  1
Surgical and medical procedures   
Fracture reduction * 1  1/1902 (0.05%)  1
Hip arthroplasty * 1  1/1902 (0.05%)  1
Urethral stent insertion * 1  1/1902 (0.05%)  1
Vascular disorders   
Aneurysm * 1  1/1902 (0.05%)  1
Blood pressure fluctuation * 1  1/1902 (0.05%)  1
Deep vein thrombosis * 1  8/1902 (0.42%)  10
Hot flush * 1  1/1902 (0.05%)  1
Hypotension * 1  3/1902 (0.16%)  5
Ischaemia * 1  1/1902 (0.05%)  1
Jugular vein thrombosis * 1  1/1902 (0.05%)  2
Orthostatic hypotension * 1  1/1902 (0.05%)  1
Thrombosis * 1  1/1902 (0.05%)  3
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sipuleucel-T
Affected / at Risk (%) # Events
Total   12/1902 (0.63%)    
Injury, poisoning and procedural complications   
Subdural haematoma * 1  2/1902 (0.11%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour haemorrhage * 1  1/1902 (0.05%)  1
Nervous system disorders   
Aphasia * 1  1/1902 (0.05%)  1
Cerebral haemorrhage * 1  1/1902 (0.05%)  1
Cerebral infarction * 1  1/1902 (0.05%)  1
Cerebrovascular accident * 1  2/1902 (0.11%)  3
Ischaemic stroke * 1  1/1902 (0.05%)  1
Seizure * 1  1/1902 (0.05%)  1
Transient ischaemic attack * 1  2/1902 (0.11%)  2
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
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: NCT01306890    
Other Study ID Numbers: P10-3
First Submitted: February 28, 2011
First Posted: March 2, 2011
Results First Submitted: January 31, 2018
Results First Posted: June 7, 2019
Last Update Posted: June 7, 2019