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← Malignant Prostate Neoplasm

NCT01715285 · STUDY IN CONTEXT

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-

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

Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 \[PCWG2\] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.

Intention to treat (ITT) analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

→

primary · POSTED

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

ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

→

secondary · POSTED

Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.

ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

→

secondary · POSTED

Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.

ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

→

secondary · POSTED

Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (\>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (\>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.

ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

→

secondary · POSTED

Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.

ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment 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

Brief Pain Inventory · Time to Pain Progression

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-prostate-neoplasm
nct id
NCT01715285
qol key
qol-0004
source section id
NCT01715285-om-0004
source outcome index
4
instrument
Brief Pain Inventory
instrument basis
matched 'brief pain inventory' in the study's own wording
scale title
Time to Pain Progression
measure definition
Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (\>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (\>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.
time frame
Up to 66 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment 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
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-malignant-prostate-neoplasm
nct id
NCT01715285
trial label
A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-
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
6
harms Count
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0000
    source section id
    NCT01715285-om-0000
    source outcome index
    0
    endpoint
    Radiographic Progression-Free Survival (PFS)
    endpoint definition
    Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 \[PCWG2\] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.
    time origin
    Up to 44 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intention to treat (ITT) analysis set included all subjects randomized into the study and who were classified according to their assigned treatment 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
    NCT01715285
    outcome key
    om-0001
    source section id
    NCT01715285-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall survival was defined as the time from randomization to date of death from any cause.
    time origin
    Up to 66 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment 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
    NCT01715285
    outcome key
    om-0002
    source section id
    NCT01715285-om-0002
    source outcome index
    2
    endpoint
    Time to Initiation of Chemotherapy
    endpoint definition
    Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
    time origin
    Up to 66 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment 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
    NCT01715285
    outcome key
    om-0003
    source section id
    NCT01715285-om-0003
    source outcome index
    3
    endpoint
    Time to Subsequent Therapy for Prostate Cancer
    endpoint definition
    Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.
    time origin
    Up to 66 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment 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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0004
    source section id
    NCT01715285-om-0004
    source outcome index
    4
    endpoint
    Time to Pain Progression
    endpoint definition
    Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (\>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (\>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.
    time origin
    Up to 66 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment 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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0005
    source section id
    NCT01715285-om-0005
    source outcome index
    5
    endpoint
    Time to Skeletal-Related Event
    endpoint definition
    Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.
    time origin
    Up to 66 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment 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
    NCT01715285
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Abiraterone Acetate+Prednisone+ADT
    regimen
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    analyzed count
    597
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo + ADT
    regimen
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    analyzed count
    602
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Abiraterone Acetate+Prednisone+ADT
    regimen
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    analyzed count
    597
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo + ADT
    regimen
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    analyzed count
    602
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Abiraterone Acetate+Prednisone+ADT
    regimen
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    analyzed count
    597
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo + ADT
    regimen
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    analyzed count
    602
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Abiraterone Acetate+Prednisone+ADT
    regimen
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    analyzed count
    597
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo + ADT
    regimen
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    analyzed count
    602
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Abiraterone Acetate+Prednisone+ADT
    regimen
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    analyzed count
    597
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo + ADT
    regimen
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    analyzed count
    602
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Abiraterone Acetate+Prednisone+ADT
    regimen
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    analyzed count
    597
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo + ADT
    regimen
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    analyzed count
    602
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01715285-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT01715285
    harm key
    EG000
    source section id
    NCT01715285-ae
    event group key
    EG000
    event group label
    Abiraterone Acetate+Prednisone+ADT
    serious affected
    192
    serious at risk
    597
    other affected
    533
    other at risk
    597
    frequency threshold
    5
    collection period
    From Day 1 up to 30 days post last dose (that is, for DB period: up to 23 months and OLE period: up to 15.6 months), deaths were collected from baseline up to end of study (up to 66 months).
    event definition
    Safety analysis set included all participants randomized into the study and who received any part of study drug. Only 72 deaths out of all cause mortalities contributed to discontinuation.
    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
    NCT01715285
    harm key
    EG001
    source section id
    NCT01715285-ae
    event group key
    EG001
    event group label
    Placebo + ADT
    serious affected
    151
    serious at risk
    602
    other affected
    515
    other at risk
    602
    frequency threshold
    5
    collection period
    From Day 1 up to 30 days post last dose (that is, for DB period: up to 23 months and OLE period: up to 15.6 months), deaths were collected from baseline up to end of study (up to 66 months).
    event definition
    Safety analysis set included all participants randomized into the study and who received any part of study drug. Only 72 deaths out of all cause mortalities contributed to discontinuation.
    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
    NCT01715285
    harm key
    EG002
    source section id
    NCT01715285-ae
    event group key
    EG002
    event group label
    DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate
    serious affected
    4
    serious at risk
    72
    other affected
    35
    other at risk
    72
    frequency threshold
    5
    collection period
    From Day 1 up to 30 days post last dose (that is, for DB period: up to 23 months and OLE period: up to 15.6 months), deaths were collected from baseline up to end of study (up to 66 months).
    event definition
    Safety analysis set included all participants randomized into the study and who received any part of study drug. Only 72 deaths out of all cause mortalities contributed to discontinuation.
    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-malignant-prostate-neoplasm
    nct id
    NCT01715285
    qol key
    qol-0004
    source section id
    NCT01715285-om-0004
    source outcome index
    4
    instrument
    Brief Pain Inventory
    instrument basis
    matched 'brief pain inventory' in the study's own wording
    scale title
    Time to Pain Progression
    measure definition
    Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (\>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (\>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.
    time frame
    Up to 66 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment 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
setting source links

    Preserved source evidence · Not medical advice