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← Prostate Cancer

NCT00033631 · STUDY IN CONTEXT

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

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

Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.

All eligible patients who did not withdraw consent

→

secondary · POSTED

Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.

All eligible patients who did not withdraw consent

→

secondary · POSTED

Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.

All eligible patients who did not withdraw consent

→

secondary · POSTED

Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.

All eligible patients who have not withdrawn consent

→

secondary · POSTED

Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.

All eligible patients who have not withdrawn consent

→

secondary · POSTED

Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0

Eligible patients with acute adverse event data who did not withdraw consent.

→

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

Unnamed quality-of-life measure · Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00033631
qol key
qol-0007
source section id
NCT00033631-om-0007
source outcome index
7
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months
measure definition
The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change \>= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM \< change \< SEM; Declined: when change \<= SEM.
time frame
Baseline and 12 months from randomization
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicating a better
population note
Eligible participants with baseline and 12 month SQLI
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00033631
trial label
Radiation Therapy in Treating Patients With Stage II Prostate Cancer
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
6
harms Count
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0000
    source section id
    NCT00033631-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.
    time origin
    From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients who did not withdraw consent
    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
    NCT00033631
    outcome key
    om-0001
    source section id
    NCT00033631-om-0001
    source outcome index
    1
    endpoint
    Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition
    endpoint definition
    Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.
    time origin
    From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients who did not withdraw consent
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0002
    source section id
    NCT00033631-om-0002
    source outcome index
    2
    endpoint
    Disease Specific Survival
    endpoint definition
    Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.
    time origin
    From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients who did not withdraw consent
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0003
    source section id
    NCT00033631-om-0003
    source outcome index
    3
    endpoint
    Local Progression
    endpoint definition
    Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
    time origin
    From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients who have not withdrawn consent
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0004
    source section id
    NCT00033631-om-0004
    source outcome index
    4
    endpoint
    Distant Metastases
    endpoint definition
    Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
    time origin
    From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients who have not withdrawn consent
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0005
    source section id
    NCT00033631-om-0005
    source outcome index
    5
    endpoint
    Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity
    endpoint definition
    Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0
    time origin
    From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients with acute adverse event data who did not withdraw consent.
    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
    NCT00033631
    outcome key
    om-0000
    arm key
    OG000
    arm label
    70.2 Gy
    regimen
    70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
    analyzed count
    751
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0000
    arm key
    OG001
    arm label
    79.2 Gy
    regimen
    79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
    analyzed count
    748
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0001
    arm key
    OG000
    arm label
    70.2 Gy
    regimen
    70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
    analyzed count
    751
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0001
    arm key
    OG001
    arm label
    79.2 Gy
    regimen
    79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
    analyzed count
    748
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0002
    arm key
    OG000
    arm label
    70.2 Gy
    regimen
    70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
    analyzed count
    751
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0002
    arm key
    OG001
    arm label
    79.2 Gy
    regimen
    79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
    analyzed count
    748
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0003
    arm key
    OG000
    arm label
    70.2 Gy
    regimen
    70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
    analyzed count
    751
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0003
    arm key
    OG001
    arm label
    79.2 Gy
    regimen
    79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
    analyzed count
    748
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0004
    arm key
    OG000
    arm label
    70.2 Gy
    regimen
    70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
    analyzed count
    751
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0004
    arm key
    OG001
    arm label
    79.2 Gy
    regimen
    79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
    analyzed count
    748
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0005
    arm key
    OG000
    arm label
    70.2 Gy
    regimen
    70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
    analyzed count
    733
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    outcome key
    om-0005
    arm key
    OG001
    arm label
    79.2 Gy
    regimen
    79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
    analyzed count
    728
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00033631-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    harm key
    EG000
    source section id
    NCT00033631-ae
    event group key
    EG000
    event group label
    70.2 Gy
    serious affected
    30
    serious at risk
    744
    other affected
    714
    other at risk
    744
    frequency threshold
    5
    collection period
    Source null
    event definition
    Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
    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
    NCT00033631
    harm key
    EG001
    source section id
    NCT00033631-ae
    event group key
    EG001
    event group label
    79.2 Gy
    serious affected
    43
    serious at risk
    737
    other affected
    704
    other at risk
    737
    frequency threshold
    5
    collection period
    Source null
    event definition
    Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00033631
    qol key
    qol-0007
    source section id
    NCT00033631-om-0007
    source outcome index
    7
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months
    measure definition
    The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change \>= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM \< change \< SEM; Declined: when change \<= SEM.
    time frame
    Baseline and 12 months from randomization
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores indicating a better
    population note
    Eligible participants with baseline and 12 month SQLI
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice