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← Malignant Prostate Neoplasm

NCT00638690 · STUDY IN CONTEXT

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.

Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.

→

secondary · POSTED

The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.

Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.

→

secondary · POSTED

A prostate-specific antigen (PSA) response was defined as a \>=50% decline from baseline.

Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.

→

secondary · POSTED

Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be \>=2.0 cm to be considered a target lesion; progression on bone scans with \>=2 new lesions not consistent with tumor flare, confirmed on a second scan \>=6 weeks later that shows \>=1 additional new lesion.

Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.

→

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-malignant-prostate-neoplasm
nct id
NCT00638690
trial label
Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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
4
harms Count
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0000
    source section id
    NCT00638690-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.
    time origin
    Up to 60 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.
    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-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0001
    source section id
    NCT00638690-om-0001
    source outcome index
    1
    endpoint
    Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
    endpoint definition
    The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.
    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-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0002
    source section id
    NCT00638690-om-0002
    source outcome index
    2
    endpoint
    Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%
    endpoint definition
    A prostate-specific antigen (PSA) response was defined as a \>=50% decline from baseline.
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.
    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-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0003
    source section id
    NCT00638690-om-0003
    source outcome index
    3
    endpoint
    Radiographic Progression-free Survival
    endpoint definition
    Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be \>=2.0 cm to be considered a target lesion; progression on bone scans with \>=2 new lesions not consistent with tumor flare, confirmed on a second scan \>=6 weeks later that shows \>=1 additional new lesion.
    time origin
    Up to 11 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.
    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-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Abiraterone Acetate
    regimen
    Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
    analyzed count
    797
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00638690-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
    analyzed count
    398
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00638690-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Abiraterone Acetate
    regimen
    Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
    analyzed count
    797
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00638690-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
    analyzed count
    398
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00638690-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Abiraterone Acetate
    regimen
    Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
    analyzed count
    797
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00638690-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
    analyzed count
    398
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00638690-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Abiraterone Acetate
    regimen
    Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
    analyzed count
    797
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00638690-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00638690
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
    analyzed count
    398
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00638690-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00638690
    harm key
    EG000
    source section id
    NCT00638690-ae
    event group key
    EG000
    event group label
    Abiraterone Acetate
    serious affected
    365
    serious at risk
    791
    other affected
    766
    other at risk
    791
    frequency threshold
    5
    collection period
    5 years
    event definition
    Following interim analysis of the study by the Independent Data Monitoring Committee in August 2010, the protocol was amended to provide for the unblinding of all study participants and the option for placebo participants to receive abiraterone acetate treatment; 67 placebo participants crossed over.
    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-malignant-prostate-neoplasm
    nct id
    NCT00638690
    harm key
    EG001
    source section id
    NCT00638690-ae
    event group key
    EG001
    event group label
    Placebo
    serious affected
    175
    serious at risk
    394
    other affected
    381
    other at risk
    394
    frequency threshold
    5
    collection period
    5 years
    event definition
    Following interim analysis of the study by the Independent Data Monitoring Committee in August 2010, the protocol was amended to provide for the unblinding of all study participants and the option for placebo participants to receive abiraterone acetate treatment; 67 placebo participants crossed over.
    undenominated note
    Source null
    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-malignant-prostate-neoplasm
    nct id
    NCT00638690
    harm key
    EG002
    source section id
    NCT00638690-ae
    event group key
    EG002
    event group label
    Placebo to Abiraterone Acetate
    serious affected
    29
    serious at risk
    67
    other affected
    57
    other at risk
    67
    frequency threshold
    5
    collection period
    5 years
    event definition
    Following interim analysis of the study by the Independent Data Monitoring Committee in August 2010, the protocol was amended to provide for the unblinding of all study participants and the option for placebo participants to receive abiraterone acetate treatment; 67 placebo participants crossed over.
    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