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← Jevtana: metastatic Prostate Cancer

NCT00005947 · STUDY IN CONTEXT

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to 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

The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).

all randomized participants

→

secondary · POSTED

Overall Survival

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
NCT00005947
trial label
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to 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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT00005947
    outcome key
    om-0000
    source section id
    NCT00005947-om-0000
    source outcome index
    0
    endpoint
    Time to Objective Disease Progression
    endpoint definition
    The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).
    time origin
    36 months from randomization
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    all randomized participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT00005947
    outcome key
    om-0001
    source section id
    NCT00005947-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    Overall Survival
    time origin
    From randomization to 36 months
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT00005947
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Sipuleucel-T
    regimen
    All subjects randomized to receive sipuleucel-T.
    analyzed count
    82
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00005947-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT00005947
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo
    regimen
    All subjects randomized to receive placebo
    analyzed count
    45
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00005947-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT00005947
    outcome key
    om-0001
    arm key
    OG000
    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 consist of 3 doses administered approximately 2 weeks apart.
    analyzed count
    82
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00005947-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT00005947
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo
    regimen
    All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
    analyzed count
    45
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00005947-om-0001#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT00005947
    harm key
    EG000
    source section id
    NCT00005947-ae
    event group key
    EG000
    event group label
    Sipuleucel-T
    serious affected
    22
    serious at risk
    82
    other affected
    82
    other at risk
    82
    frequency threshold
    5
    collection period
    4 years, 8 months
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT00005947
    harm key
    EG001
    source section id
    NCT00005947-ae
    event group key
    EG001
    event group label
    Placebo
    serious affected
    8
    serious at risk
    45
    other affected
    44
    other at risk
    45
    frequency threshold
    5
    collection period
    4 years, 8 months
    event definition
    Source null
    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