Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy (NCT NCT00005947)
NCT ID: NCT00005947
Last Updated: 2010-11-01
Results Overview
The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
127 participants
Primary outcome timeframe
36 months from randomization
Results posted on
2010-11-01
Participant Flow
Participants were randomized between January 2000 and September 2004 across 16 clinical trial sites.
Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
Participant milestones
| Measure |
Sipuleucel-T
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.
|
Placebo
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 Study
STARTED
|
82
|
45
|
|
Overall Study
COMPLETED
|
25
|
4
|
|
Overall Study
NOT COMPLETED
|
57
|
41
|
Reasons for withdrawal
| Measure |
Sipuleucel-T
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.
|
Placebo
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 Study
Death
|
54
|
40
|
|
Overall Study
Patient Refused to Continue
|
2
|
1
|
|
Overall Study
Site Closure
|
1
|
0
|
Baseline Characteristics
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Baseline characteristics by cohort
| Measure |
Sipuleucel-T
n=82 Participants
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.
|
Placebo
n=45 Participants
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
72.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
71.7 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Age, Customized
|
73.0 Years (Min, Max)
n=5 Participants
|
71.0 Years (Min, Max)
n=7 Participants
|
73.0 Years (Min, Max)
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 months from randomizationPopulation: all randomized participants
The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).
Outcome measures
| Measure |
Sipuleucel-T
n=82 Participants
All subjects randomized to receive sipuleucel-T.
|
Placebo
n=45 Participants
All subjects randomized to receive placebo
|
|---|---|---|
|
Time to Objective Disease Progression
|
11.7 Weeks
Interval 9.1 to 16.6
|
10.0 Weeks
Interval 8.7 to 13.1
|
SECONDARY outcome
Timeframe: From randomization to 36 monthsOverall Survival
Outcome measures
| Measure |
Sipuleucel-T
n=82 Participants
All subjects randomized to receive sipuleucel-T.
|
Placebo
n=45 Participants
All subjects randomized to receive placebo
|
|---|---|---|
|
Overall Survival
|
25.9 Months
Interval 20.0 to 32.4
|
21.4 Months
Interval 12.3 to 25.8
|
Adverse Events
Sipuleucel-T
Serious events: 22 serious events
Other events: 82 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sipuleucel-T
n=82 participants at risk
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.
|
Placebo
n=45 participants at risk
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Nervous system disorders
Aphasia
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Renal and urinary disorders
Bladder Obstruction
|
0.00%
0/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Investigations
Blood creatinine increased
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Infections and infestations
Catheter related infection
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Infections and infestations
Catheter sepsis
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Nervous system disorders
Cerebrovascular accident
|
2.4%
2/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
General disorders
Chest pain
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
General disorders
Chills
|
2.4%
2/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
3/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
General disorders
Gait disturbance
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Renal and urinary disorders
Haematuria
|
1.2%
1/82 • 4 years, 8 months
|
4.4%
2/45 • 4 years, 8 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Investigations
Heart rate irregular
|
0.00%
0/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Nervous system disorders
Lumbar radiculopathy
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
General disorders
Pain
|
0.00%
0/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
General disorders
Pyrexia
|
2.4%
2/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Eye disorders
Retinal detachment
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Infections and infestations
Sepsis
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Nervous system disorders
Spinal cord compression
|
2.4%
2/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Nervous system disorders
Syncope
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Investigations
Transaminases increased
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Nervous system disorders
Transient ischaemic attack
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
2/82 • 4 years, 8 months
|
4.4%
2/45 • 4 years, 8 months
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Investigations
White blood cell count increased
|
1.2%
1/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
Other adverse events
| Measure |
Sipuleucel-T
n=82 participants at risk
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.
|
Placebo
n=45 participants at risk
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.5%
7/82 • 4 years, 8 months
|
15.6%
7/45 • 4 years, 8 months
|
|
Gastrointestinal disorders
Constipation
|
11.0%
9/82 • 4 years, 8 months
|
15.6%
7/45 • 4 years, 8 months
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
6/82 • 4 years, 8 months
|
11.1%
5/45 • 4 years, 8 months
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
4/82 • 4 years, 8 months
|
6.7%
3/45 • 4 years, 8 months
|
|
Gastrointestinal disorders
Nausea
|
14.6%
12/82 • 4 years, 8 months
|
11.1%
5/45 • 4 years, 8 months
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
10/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
General disorders
Asthenia
|
11.0%
9/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
General disorders
Chills
|
62.2%
51/82 • 4 years, 8 months
|
8.9%
4/45 • 4 years, 8 months
|
|
General disorders
Fatigue
|
43.9%
36/82 • 4 years, 8 months
|
37.8%
17/45 • 4 years, 8 months
|
|
General disorders
Feeling cold
|
9.8%
8/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
General disorders
Influenza like illness
|
6.1%
5/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
General disorders
Oedema peripheral
|
7.3%
6/82 • 4 years, 8 months
|
11.1%
5/45 • 4 years, 8 months
|
|
General disorders
Pain
|
6.1%
5/82 • 4 years, 8 months
|
11.1%
5/45 • 4 years, 8 months
|
|
General disorders
Pyrexia
|
34.1%
28/82 • 4 years, 8 months
|
4.4%
2/45 • 4 years, 8 months
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
6/82 • 4 years, 8 months
|
4.4%
2/45 • 4 years, 8 months
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
1/82 • 4 years, 8 months
|
6.7%
3/45 • 4 years, 8 months
|
|
Investigations
Weight decreased
|
7.3%
6/82 • 4 years, 8 months
|
4.4%
2/45 • 4 years, 8 months
|
|
Metabolism and nutrition disorders
Anorexia
|
8.5%
7/82 • 4 years, 8 months
|
11.1%
5/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.6%
12/82 • 4 years, 8 months
|
11.1%
5/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.0%
18/82 • 4 years, 8 months
|
22.2%
10/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
11.0%
9/82 • 4 years, 8 months
|
8.9%
4/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
6.1%
5/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.1%
5/82 • 4 years, 8 months
|
8.9%
4/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.5%
7/82 • 4 years, 8 months
|
4.4%
2/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.1%
5/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.5%
7/82 • 4 years, 8 months
|
11.1%
5/45 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
7.3%
6/82 • 4 years, 8 months
|
4.4%
2/45 • 4 years, 8 months
|
|
Nervous system disorders
Headache
|
17.1%
14/82 • 4 years, 8 months
|
2.2%
1/45 • 4 years, 8 months
|
|
Nervous system disorders
Paraesthesia
|
15.9%
13/82 • 4 years, 8 months
|
4.4%
2/45 • 4 years, 8 months
|
|
Nervous system disorders
Tremor
|
9.8%
8/82 • 4 years, 8 months
|
0.00%
0/45 • 4 years, 8 months
|
|
Psychiatric disorders
Insomnia
|
1.2%
1/82 • 4 years, 8 months
|
8.9%
4/45 • 4 years, 8 months
|
|
Renal and urinary disorders
Dysuria
|
2.4%
2/82 • 4 years, 8 months
|
8.9%
4/45 • 4 years, 8 months
|
|
Renal and urinary disorders
Haematuria
|
6.1%
5/82 • 4 years, 8 months
|
6.7%
3/45 • 4 years, 8 months
|
|
Renal and urinary disorders
Pollakiuria
|
1.2%
1/82 • 4 years, 8 months
|
8.9%
4/45 • 4 years, 8 months
|
|
Renal and urinary disorders
Urinary retention
|
4.9%
4/82 • 4 years, 8 months
|
8.9%
4/45 • 4 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
4/82 • 4 years, 8 months
|
11.1%
5/45 • 4 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.1%
14/82 • 4 years, 8 months
|
4.4%
2/45 • 4 years, 8 months
|
|
Vascular disorders
Flushing
|
2.4%
2/82 • 4 years, 8 months
|
6.7%
3/45 • 4 years, 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER