Trial Outcomes & Findings for Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer (NCT NCT01133704)

Last Updated: 2010-09-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

98 participants

Primary outcome timeframe

from randomization to 36 months

Results posted on

2010-09-08

Participant Flow

Participants were randomized between May 2000 and March 2003 across 24 clinical trial sites.

Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.

Participant milestones

Participant milestones
Measure	Sipuleucel-T (APC8015) 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	65	33
Overall Study COMPLETED	16	7
Overall Study NOT COMPLETED	49	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Sipuleucel-T (APC8015) 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	44	26
Overall Study Patient refused to continue	4	0
Overall Study Study Closure	1	0

Baseline Characteristics

Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sipuleucel-T (APC8015) n=65 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=33 Participants 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 n=98 Participants Total of all reporting groups
Age Continuous	69.6 years STANDARD_DEVIATION 8.2 • n=5 Participants	70.6 years STANDARD_DEVIATION 7.8 • n=7 Participants	69.9 years STANDARD_DEVIATION 8.1 • 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	65 Participants n=5 Participants	33 Participants n=7 Participants	98 Participants n=5 Participants

PRIMARY outcome

Timeframe: from randomization to 36 months

Outcome measures

Outcome measures
Measure	Sipuleucel-T (APC8015) n=65 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=33 Participants 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 Time to Disease Progression	10.9 Weeks Interval 9.3 to 17.7	9.9 Weeks Interval 8.4 to 18.0

SECONDARY outcome

Timeframe: Time from randomization until 36 months

Population: All randomized participants

Subjects were followed for 3 years from the time of randomization or until death.

Outcome measures

Outcome measures
Measure	Sipuleucel-T (APC8015) n=65 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=33 Participants 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 Survival	19.0 Months Interval 13.6 to 31.9	15.7 Months Interval 12.8 to 25.4

Adverse Events

Sipuleucel-T (APC8015)

Serious events: 13 serious events

Other events: 63 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Kathleen Picha

Dendreon Corporation

Phone: 206-265-4545

Email: [email protected]

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

Serious adverse events
Measure	Sipuleucel-T (APC8015) n=65 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=31 participants at risk 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.
Vascular disorders Embolism	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Vascular disorders Hypertension	3.1% 2/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Vascular disorders Hypotension	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Blood and lymphatic system disorders Anaemia	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Blood and lymphatic system disorders Disseminated intravascular coagulation	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Cardiac disorders Atrial flutter	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Cardiac disorders Cardiac failure	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Cardiac disorders Cardiac failure congestive	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Cardiac disorders Supraventricular tachycardia	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Cardiac disorders Tachycardia	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Gastrointestinal disorders Nausea	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Adverse drug reaction	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Chills	4.6% 3/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Disease Progression	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Pain	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Pyrexia	3.1% 2/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Infections and infestations Bacteraemia	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Infections and infestations Bacterial sepsis	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Infections and infestations Catheter sepsis	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Infections and infestations Cellulitis	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Infections and infestations Extradural abscess	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Infections and infestations Sepsis	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Infections and infestations Staphylococcal bacteraemia	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Infections and infestations Staphylococcal sepsis	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Infections and infestations Urinary tract infection	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Metabolism and nutrition disorders Dehydration	3.1% 2/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Back Pain	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Chest wall pain	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Nervous system disorders Brain mass	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Nervous system disorders Cerebral haemorrhage	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Nervous system disorders Cerebrovascular accident	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Nervous system disorders Facial palsy	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Nervous system disorders Headache	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.

Other adverse events
Measure	Sipuleucel-T (APC8015) n=65 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=31 participants at risk 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.
Blood and lymphatic system disorders Anaemia	20.0% 13/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Gastrointestinal disorders Constipation	7.7% 5/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	12.9% 4/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Gastrointestinal disorders Diarrhoea	6.2% 4/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Gastrointestinal disorders Dyspepsia	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Gastrointestinal disorders Hypoaesthesia Oral	6.2% 4/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Gastrointestinal disorders Nausea	13.8% 9/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Gastrointestinal disorders Vomiting	9.2% 6/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Asthenia	18.5% 12/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Chills	52.3% 34/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Fatigue	41.5% 27/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	16.1% 5/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Influenza Like Illness	6.2% 4/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Malaise	6.2% 4/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Oedema Peripheral	10.8% 7/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	16.1% 5/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Pain	13.8% 9/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
General disorders Pyrexia	29.2% 19/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	9.7% 3/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Injury, poisoning and procedural complications Citrate Toxicity	15.4% 10/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	16.1% 5/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Metabolism and nutrition disorders Anorexia	9.2% 6/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Metabolism and nutrition disorders Dehydration	6.2% 4/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 10/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	29.0% 9/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Back Pain	21.5% 14/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	25.8% 8/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Chest Wall Pain	10.8% 7/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Groin Pain	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 5/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Neck Pain	3.1% 2/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Pain in Extremity	10.8% 7/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	22.6% 7/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Musculoskeletal and connective tissue disorders Shoulder Pain	4.6% 3/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	9.7% 3/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Nervous system disorders Dizziness	12.3% 8/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Nervous system disorders Headache	21.5% 14/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	9.7% 3/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Nervous system disorders Lethargy	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Nervous system disorders Paraesthesia	9.2% 6/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	16.1% 5/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Nervous system disorders Paraesthesia Oral	7.7% 5/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	9.7% 3/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Nervous system disorders Tremor	7.7% 5/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	0.00% 0/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Psychiatric disorders Insomnia	1.5% 1/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	12.9% 4/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Renal and urinary disorders Urinary Retention	4.6% 3/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Reproductive system and breast disorders Gynaecomastia	3.1% 2/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 4/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	3.2% 1/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	4.6% 3/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.
Vascular disorders Deep Vein Thrombosis	0.00% 0/65 • From randomization through 36 months. Median follow-up was 36 months. 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.	6.5% 2/31 • From randomization through 36 months. Median follow-up was 36 months. 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.