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NCT00007644 · STUDY IN CONTEXT

Prostate Cancer Intervention Versus Observation Trial (PIVOT)

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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

Number of deaths from any cause.

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
nct id
NCT00007644
trial label
Prostate Cancer Intervention Versus Observation Trial (PIVOT)
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
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
1
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00007644
    outcome key
    om-0000
    source section id
    NCT00007644-om-0000
    source outcome index
    0
    endpoint
    All Cause Mortality
    endpoint definition
    Number of deaths from any cause.
    time origin
    From date of randomization until date of death from any cause, assessed until end of study, up to 16 years
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00007644
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Radical Prostatectomy
    regimen
    Surgical removal of the prostate Radical prostatectomy: Surgical removal of the prostate
    analyzed count
    364
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00007644-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00007644
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Watchful Waiting
    regimen
    Closely watching, waiting and treating symptoms if and when cancer progresses
    analyzed count
    367
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00007644-om-0000#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00007644
    harm key
    EG000
    source section id
    NCT00007644-ae
    event group key
    EG000
    event group label
    Radical Prostatectomy
    serious affected
    171
    serious at risk
    364
    other affected
    0
    other at risk
    364
    frequency threshold
    0
    collection period
    Source null
    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
    nct id
    NCT00007644
    harm key
    EG001
    source section id
    NCT00007644-ae
    event group key
    EG001
    event group label
    Watchful Waiting
    serious affected
    183
    serious at risk
    367
    other affected
    0
    other at risk
    367
    frequency threshold
    0
    collection period
    Source null
    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