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← Malignant Prostate Neoplasm

NCT00417079 · STUDY IN CONTEXT

XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic 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. 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 was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.

Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).

→

secondary · POSTED

Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first

Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).

→

secondary · POSTED

Tumor Overall Response Rate (ORR) (only in patients with measurable disease): Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria. Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD. Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response.

Tumor response rate was evaluated only for patients, in the Intention-To-Treat (ITT) population, with measurable disease by Response Evaluation Criteria in Solid Tumor (RECIST).

→

secondary · POSTED

Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)

Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).

→

secondary · POSTED

In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later. In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.

Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).

→

secondary · POSTED

PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.

Prostate Specific Antigen (PSA) response was evaluated only in patients, in the Intention-To-Treat population, with a baseline PSA \>20ng/mL.

→

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
NCT00417079
trial label
XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic 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. 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
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0000
    source section id
    NCT00417079-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.
    time origin
    From the date of randomization up to 104 weeks (study cut-off)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
    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
    NCT00417079
    outcome key
    om-0001
    source section id
    NCT00417079-om-0001
    source outcome index
    1
    endpoint
    Time to Progression Free Survival (PFS)
    endpoint definition
    Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first
    time origin
    From the date of randomization up to 104 weeks (study cut-off)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
    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
    NCT00417079
    outcome key
    om-0002
    source section id
    NCT00417079-om-0002
    source outcome index
    2
    endpoint
    Overall Tumor Response
    endpoint definition
    Tumor Overall Response Rate (ORR) (only in patients with measurable disease): Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria. Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD. Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response.
    time origin
    From the date of randomization up to 104 weeks (study cut-off)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Tumor response rate was evaluated only for patients, in the Intention-To-Treat (ITT) population, with measurable disease by Response Evaluation Criteria in Solid Tumor (RECIST).
    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
    NCT00417079
    outcome key
    om-0003
    source section id
    NCT00417079-om-0003
    source outcome index
    3
    endpoint
    Time to Tumor Progression
    endpoint definition
    Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)
    time origin
    From the date of randomization up to 104 weeks (study cut-off)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
    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
    NCT00417079
    outcome key
    om-0004
    source section id
    NCT00417079-om-0004
    source outcome index
    4
    endpoint
    Time to Prostatic Specific Antigen (PSA) Progression
    endpoint definition
    In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later. In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.
    time origin
    at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
    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
    NCT00417079
    outcome key
    om-0005
    source section id
    NCT00417079-om-0005
    source outcome index
    5
    endpoint
    PSA (Prostate-Specific Antigen) Response
    endpoint definition
    PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.
    time origin
    from baseline up to 104 weeks (study cut-off)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Prostate Specific Antigen (PSA) response was evaluated only in patients, in the Intention-To-Treat population, with a baseline PSA \>20ng/mL.
    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
    NCT00417079
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Mitoxantrone + Prednisone
    regimen
    mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    377
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cabazitaxel + Prednisone
    regimen
    cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    378
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Mitoxantrone + Prednisone
    regimen
    mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    377
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Cabazitaxel + Prednisone
    regimen
    cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    378
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Mitoxantrone + Prednisone
    regimen
    mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    204
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Cabazitaxel + Prednisone
    regimen
    cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    201
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Mitoxantrone + Prednisone
    regimen
    mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    377
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Cabazitaxel + Prednisone
    regimen
    cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    378
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Mitoxantrone + Prednisone
    regimen
    mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    377
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Cabazitaxel + Prednisone
    regimen
    cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    378
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Mitoxantrone + Prednisone
    regimen
    mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    325
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Cabazitaxel + Prednisone
    regimen
    cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    analyzed count
    329
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00417079-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT00417079
    harm key
    EG000
    source section id
    NCT00417079-ae
    event group key
    EG000
    event group label
    Mitoxantrone + Prednisone
    serious affected
    77
    serious at risk
    371
    other affected
    323
    other at risk
    371
    frequency threshold
    5
    collection period
    Adverse events are collected from the time to the first patient signed an informed consent form until 30 days after the administration of the last cycle of the study treatment to the last patient (i.e. 104 weeks).
    event definition
    The safety analyses are performed on the safety population which includes all randomized patients who received at least part of one dose of the study drug.
    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
    NCT00417079
    harm key
    EG001
    source section id
    NCT00417079-ae
    event group key
    EG001
    event group label
    Cabazitaxel + Prednisone
    serious affected
    145
    serious at risk
    371
    other affected
    350
    other at risk
    371
    frequency threshold
    5
    collection period
    Adverse events are collected from the time to the first patient signed an informed consent form until 30 days after the administration of the last cycle of the study treatment to the last patient (i.e. 104 weeks).
    event definition
    The safety analyses are performed on the safety population which includes all randomized patients who received at least part of one dose of the study drug.
    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