NCT00065442 · STUDY IN CONTEXT

Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Time from randomization until death due to any cause.

Source null

→

secondary · POSTED

Measured by imaging studies; confirmed by independent imaging review

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-prostate-cancer-jevtana-f72c24a3
nct id: NCT00065442
trial label: Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 2
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT00065442
outcome key
om-0000
source section id
NCT00065442-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
Time from randomization until death due to any cause.
time origin
Event-driven timeframe. Final analysis at 331 events.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT00065442
outcome key
om-0001
source section id
NCT00065442-om-0001
source outcome index
1
endpoint
Time to Objective Disease Progression
endpoint definition
Measured by imaging studies; confirmed by independent imaging review
time origin
Analysis conducted at the time of overall survival analysis
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT00065442
outcome key
om-0000
arm key
OG000
arm label
APC-Placebo
regimen
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
analyzed count
171
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00065442-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT00065442
outcome key
om-0000
arm key
OG001
arm label
Sipuleucel-T
regimen
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 consists of 3 doses administered approximately 2 weeks apart.
analyzed count
341
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00065442-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT00065442
outcome key
om-0001
arm key
OG000
arm label
APC-Placebo
regimen
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
analyzed count
171
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00065442-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT00065442
outcome key
om-0001
arm key
OG001
arm label
Sipuleucel-T
regimen
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 consists of 3 doses administered approximately 2 weeks apart.
analyzed count
341
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00065442-om-0001#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT00065442
harm key
EG000
source section id
NCT00065442-ae
event group key
EG000
event group label
APC-Placebo
serious affected
40
serious at risk
168
other affected
162
other at risk
168
frequency threshold
5
collection period
From randomization until time of overall survival analysis.
event definition
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.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT00065442
harm key
EG001
source section id
NCT00065442-ae
event group key
EG001
event group label
Sipuleucel-T
serious affected
82
serious at risk
338
other affected
334
other at risk
338
frequency threshold
5
collection period
From randomization until time of overall survival analysis.
event definition
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.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice