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← Xtandi: metastatic Prostate Cancer

NCT02485691 · STUDY IN CONTEXT

Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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 progression-free survival: time (in months) from randomization to occurrence of any one of following: radiological tumor progressions using response evaluation criteria in solid tumors (RECIST 1.1), progression of bone lesions using Prostate Cancer Working Group 2 (PCWG2) criteria or occurrence of death due to any cause. Progression as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with \>= 2 new lesions compared to Baseline observed less than (\<) 12 weeks from randomization and confirmed by a second bone scan performed \>=6 weeks; first bone scan with \>=2 new lesions compared to Baseline observed \>=12 weeks from randomization. In accordance with protocol, data cut-off date for final analysis of this endpoint was the date when 196 rPFS events had occurred. Analysis done by Kaplan-Meier method.

Analysis was performed on ITT population.

→

secondary · POSTED

Overall survival was defined as the time interval (in months) from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date whichever comes first. Analysis was performed by Kaplan-Meier method.

Analysis was performed on ITT population.

→

secondary · POSTED

PFS:time duration (in months) from date of randomization to date of first occurrence of any of following events: radiological tumor progression (RECIST 1.1); progression of bone lesions (PCWG2); symptomatic progression (developing urinary or bowel symptoms; need to change anti-cancer therapy), pain progression or death due to any cause. Tumor Progression(RECIST 1.1): at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesion (PCWG2 criteria): first bone scan with \>=2 new lesions compared to Baseline and confirmed by second bone scan performed \>=6 weeks later; pain progression: increase by \>=30% from Baseline in pain intensity score (calculated using scale ranged from 0=no pain to 5=extreme pain) or increase in analgesic usage score \>=30% (calculated from analgesic use data, non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points). Analyzed by Kaplan-Meier method.

Analysis was performed on ITT population.

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secondary · POSTED

PSA response was defined as \>= 50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later.

Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with PSA level \>2 ng/mL at baseline, and with at least two post-baseline assessments before any further anti-cancer therapy for specified outcome measure.

→

secondary · POSTED

Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with measurable disease at baseline and at least one post-baseline assessment before any further anti-cancer therapy for specified outcome measure.

→

secondary · POSTED

TTPP was defined as the time duration (in months) between the date of randomization and the date of first documented PSA progression. PSA progression (as per PCWG 2) was defined as: 1) If decline from Baseline value: an increase of \>=25% (at least 2 ng/mL) over the nadir value, confirmed by a second PSA value at least 3 weeks apart; 2) If no decline from Baseline value: an increase of \>=25% (at least 2 ng/mL) over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart. Analysis performed by Kaplan-Meier method.

Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with PSA level \> 2ng/mL at baseline, and with at least two post-baseline assessments before any further anti-cancer therapy for specified outcome measure.

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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 · Percentage of Participants Achieving Pain Response Assessed Using Brief Pain Inventory-Short Form (BPI-SF) Pain Intensity Score

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-prostate-cancer-xtandi-532fb7f0
nct id
NCT02485691
qol key
qol-0007
source section id
NCT02485691-om-0007
source outcome index
7
instrument
Brief Pain Inventory
instrument basis
matched 'brief pain inventory' in the study's own wording
scale title
Percentage of Participants Achieving Pain Response Assessed Using Brief Pain Inventory-Short Form (BPI-SF) Pain Intensity Score
measure definition
Pain response as per BPI-SF was defined as a decrease of at least 30% from Baseline in the average of BPI-SF pain intensity score observed at 2 consecutive evaluations \>=3 weeks apart without increase in analgesic usage score (calculated from analgesic use data, with non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points). The BPI-SF is a self-administered questionnaire developed to assess the severity of pain on a 0-10 categorical scale where 0=no pain, 10=pain as bad as you can imagine. Higher scores indicated worst outcomes. Percentage of Participants Achieving Pain Response assessed using BPI-SF Pain Intensity Score were reported.
time frame
Baseline until pain progression, first further anticancer therapy, or data cut-off whichever comes first (maximum duration: up to 141 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with baseline assessment and at least one post-baseline assessment before any further anti-cancer therapy for specified outcome measure.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
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-prostate-cancer-xtandi-532fb7f0
nct id
NCT02485691
qol key
qol-0008
source section id
NCT02485691-om-0008
source outcome index
8
instrument
Brief Pain Inventory
instrument basis
matched 'bpi' in the study's own wording
scale title
Time to Pain Progression
measure definition
Time to pain progression was defined as the time duration (in months) between the date of randomization and the date of first documented pain progression. Pain progression, in participants with no pain or stable pain at Baseline was defined as increase of \>=30% from baseline in the BPI-SF pain intensity score observed at 2 consecutive evaluations \>=3 weeks apart without decrease in analgesic usage score or increase in analgesic usage score (calculated from analgesic use data, with non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points) \>=30%. The BPI-SF is a self-administered questionnaire developed to assess the severity of pain on a 0-10 categorical scale where 0=no pain, 10=pain as bad as you can imagine. Higher scores indicated worst outcomes. Analysis was performed by Kaplan-Meier method.
time frame
Baseline until pain progression or data cut-off whichever comes first (maximum duration: up to 141 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with baseline assessment and at least one post-baseline assessment before any further anti-cancer therapy for BPI-SF pain intensity score.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Health-Related Quality of Life (HRQOL): Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment

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-xtandi-532fb7f0
nct id
NCT02485691
qol key
qol-0011
source section id
NCT02485691-om-0011
source outcome index
11
instrument
FACT
instrument basis
matched 'fact-p' in the study's own wording
scale title
Health-Related Quality of Life (HRQOL): Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment
measure definition
Health-related quality of life (HRQOL) evaluation was performed using the FACT-P questionnaire (Version 4). FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms. Baseline corresponded to last evaluable assessment before treatment administration.
time frame
Baseline, Day 1 of each Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8 and at End of Treatment (any time up to 141 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicated better
population note
Analysis was performed on HRQOL population which included participants who received at least one dose of the study drug and with an evaluable FACT-P questionnaire at baseline and at least one post-baseline evaluable FACT-P. Here 'Number analyzed' signifies participants with available data for each specified category.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Utility Single Index and Visual Analogue Scale (VAS) Scores at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment

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-xtandi-532fb7f0
nct id
NCT02485691
qol key
qol-0012
source section id
NCT02485691-om-0012
source outcome index
12
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Utility Single Index and Visual Analogue Scale (VAS) Scores at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment
measure definition
EQ-5D was a standardized HRQOL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems \& severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS scale ranging from 0-100, where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. Baseline corresponded to last evaluable assessment before treatment administration.
time frame
Baseline, Day 1 of each Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8 and at End of Treatment (any time up to: 141 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher states indicated better
population note
Analysis was performed on Health status population which included participants who received at least one dose of the study drug and with an evaluable EQ-5D-5L at baseline and with at least one post-baseline evaluable EQ-5D-5L. Here 'Number analyzed' signifies participants with available data for each specified category.
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-xtandi-532fb7f0
nct id
NCT02485691
trial label
Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
4
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0000
    source section id
    NCT02485691-om-0000
    source outcome index
    0
    endpoint
    Radiographic Progression-Free Survival (rPFS)
    endpoint definition
    Radiographic progression-free survival: time (in months) from randomization to occurrence of any one of following: radiological tumor progressions using response evaluation criteria in solid tumors (RECIST 1.1), progression of bone lesions using Prostate Cancer Working Group 2 (PCWG2) criteria or occurrence of death due to any cause. Progression as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with \>= 2 new lesions compared to Baseline observed less than (\<) 12 weeks from randomization and confirmed by a second bone scan performed \>=6 weeks; first bone scan with \>=2 new lesions compared to Baseline observed \>=12 weeks from randomization. In accordance with protocol, data cut-off date for final analysis of this endpoint was the date when 196 rPFS events had occurred. Analysis done by Kaplan-Meier method.
    time origin
    From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on ITT population.
    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-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0001
    source section id
    NCT02485691-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall survival was defined as the time interval (in months) from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date whichever comes first. Analysis was performed by Kaplan-Meier method.
    time origin
    From randomization to death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on ITT population.
    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-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0002
    source section id
    NCT02485691-om-0002
    source outcome index
    2
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    PFS:time duration (in months) from date of randomization to date of first occurrence of any of following events: radiological tumor progression (RECIST 1.1); progression of bone lesions (PCWG2); symptomatic progression (developing urinary or bowel symptoms; need to change anti-cancer therapy), pain progression or death due to any cause. Tumor Progression(RECIST 1.1): at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesion (PCWG2 criteria): first bone scan with \>=2 new lesions compared to Baseline and confirmed by second bone scan performed \>=6 weeks later; pain progression: increase by \>=30% from Baseline in pain intensity score (calculated using scale ranged from 0=no pain to 5=extreme pain) or increase in analgesic usage score \>=30% (calculated from analgesic use data, non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points). Analyzed by Kaplan-Meier method.
    time origin
    From randomization until tumor progression or bone lesion progression, pain progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on ITT population.
    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-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0003
    source section id
    NCT02485691-om-0003
    source outcome index
    3
    endpoint
    Percentage of Participants With Prostate Specific Antigen (PSA) Response
    endpoint definition
    PSA response was defined as \>= 50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later.
    time origin
    Baseline up to PSA response, death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with PSA level \>2 ng/mL at baseline, and with at least two post-baseline assessments before any further anti-cancer therapy for specified outcome measure.
    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-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0004
    source section id
    NCT02485691-om-0004
    source outcome index
    4
    endpoint
    Percentage of Participants With Overall Objective Tumor Response
    endpoint definition
    Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
    time origin
    From randomization until disease progression, death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with measurable disease at baseline and at least one post-baseline assessment before any further anti-cancer therapy for specified outcome measure.
    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-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0005
    source section id
    NCT02485691-om-0005
    source outcome index
    5
    endpoint
    Time to PSA Progression (TTPP)
    endpoint definition
    TTPP was defined as the time duration (in months) between the date of randomization and the date of first documented PSA progression. PSA progression (as per PCWG 2) was defined as: 1) If decline from Baseline value: an increase of \>=25% (at least 2 ng/mL) over the nadir value, confirmed by a second PSA value at least 3 weeks apart; 2) If no decline from Baseline value: an increase of \>=25% (at least 2 ng/mL) over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart. Analysis performed by Kaplan-Meier method.
    time origin
    From time from randomization until PSA progression, death due to any cause or data cut-off whichever comes first (maximum duration: up to 141 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with PSA level \> 2ng/mL at baseline, and with at least two post-baseline assessments before any further anti-cancer therapy for specified outcome measure.
    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-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cabazitaxel
    regimen
    Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
    analyzed count
    129
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Abiraterone Acetate or Enzalutamide
    regimen
    Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
    analyzed count
    126
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cabazitaxel
    regimen
    Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
    analyzed count
    129
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Abiraterone Acetate or Enzalutamide
    regimen
    Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
    analyzed count
    126
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cabazitaxel
    regimen
    Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
    analyzed count
    129
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Abiraterone Acetate or Enzalutamide
    regimen
    Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
    analyzed count
    126
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Cabazitaxel
    regimen
    Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
    analyzed count
    113
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Abiraterone Acetate or Enzalutamide
    regimen
    Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
    analyzed count
    105
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Cabazitaxel
    regimen
    Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
    analyzed count
    63
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Abiraterone Acetate or Enzalutamide
    regimen
    Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Cabazitaxel
    regimen
    Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
    analyzed count
    113
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Abiraterone Acetate or Enzalutamide
    regimen
    Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
    analyzed count
    105
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02485691-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02485691
    harm key
    EG000
    source section id
    NCT02485691-ae
    event group key
    EG000
    event group label
    Cabazitaxel
    serious affected
    49
    serious at risk
    126
    other affected
    114
    other at risk
    126
    frequency threshold
    5
    collection period
    Adverse event (AE) data was collected from Baseline up to 30 days after the last treatment administration (up to 197 weeks), deaths were collected from baseline up to end of study (up to 197 weeks).
    event definition
    Reported AEs were TEAEs i.e., AEs that developed/worsened during the 'on-treatment period' (time from first dose of study drug until 30 days after last administration of study drug) assessed for safety population (i.e., all participants who received at least one dose of study drugs and analyzed according to treatment they actually received). All-Cause Mortality data collected during the study was assessed for all randomized participants. Disease progression related death were not reported as AE.
    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-xtandi-532fb7f0
    nct id
    NCT02485691
    harm key
    EG001
    source section id
    NCT02485691-ae
    event group key
    EG001
    event group label
    Enzalutamide or Abiraterone
    serious affected
    50
    serious at risk
    124
    other affected
    104
    other at risk
    124
    frequency threshold
    5
    collection period
    Adverse event (AE) data was collected from Baseline up to 30 days after the last treatment administration (up to 197 weeks), deaths were collected from baseline up to end of study (up to 197 weeks).
    event definition
    Reported AEs were TEAEs i.e., AEs that developed/worsened during the 'on-treatment period' (time from first dose of study drug until 30 days after last administration of study drug) assessed for safety population (i.e., all participants who received at least one dose of study drugs and analyzed according to treatment they actually received). All-Cause Mortality data collected during the study was assessed for all randomized participants. Disease progression related death were not reported as AE.
    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-xtandi-532fb7f0
    nct id
    NCT02485691
    qol key
    qol-0007
    source section id
    NCT02485691-om-0007
    source outcome index
    7
    instrument
    Brief Pain Inventory
    instrument basis
    matched 'brief pain inventory' in the study's own wording
    scale title
    Percentage of Participants Achieving Pain Response Assessed Using Brief Pain Inventory-Short Form (BPI-SF) Pain Intensity Score
    measure definition
    Pain response as per BPI-SF was defined as a decrease of at least 30% from Baseline in the average of BPI-SF pain intensity score observed at 2 consecutive evaluations \>=3 weeks apart without increase in analgesic usage score (calculated from analgesic use data, with non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points). The BPI-SF is a self-administered questionnaire developed to assess the severity of pain on a 0-10 categorical scale where 0=no pain, 10=pain as bad as you can imagine. Higher scores indicated worst outcomes. Percentage of Participants Achieving Pain Response assessed using BPI-SF Pain Intensity Score were reported.
    time frame
    Baseline until pain progression, first further anticancer therapy, or data cut-off whichever comes first (maximum duration: up to 141 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with baseline assessment and at least one post-baseline assessment before any further anti-cancer therapy for specified outcome measure.
    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-xtandi-532fb7f0
    nct id
    NCT02485691
    qol key
    qol-0008
    source section id
    NCT02485691-om-0008
    source outcome index
    8
    instrument
    Brief Pain Inventory
    instrument basis
    matched 'bpi' in the study's own wording
    scale title
    Time to Pain Progression
    measure definition
    Time to pain progression was defined as the time duration (in months) between the date of randomization and the date of first documented pain progression. Pain progression, in participants with no pain or stable pain at Baseline was defined as increase of \>=30% from baseline in the BPI-SF pain intensity score observed at 2 consecutive evaluations \>=3 weeks apart without decrease in analgesic usage score or increase in analgesic usage score (calculated from analgesic use data, with non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points) \>=30%. The BPI-SF is a self-administered questionnaire developed to assess the severity of pain on a 0-10 categorical scale where 0=no pain, 10=pain as bad as you can imagine. Higher scores indicated worst outcomes. Analysis was performed by Kaplan-Meier method.
    time frame
    Baseline until pain progression or data cut-off whichever comes first (maximum duration: up to 141 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with baseline assessment and at least one post-baseline assessment before any further anti-cancer therapy for BPI-SF pain intensity score.
    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-xtandi-532fb7f0
    nct id
    NCT02485691
    qol key
    qol-0011
    source section id
    NCT02485691-om-0011
    source outcome index
    11
    instrument
    FACT
    instrument basis
    matched 'fact-p' in the study's own wording
    scale title
    Health-Related Quality of Life (HRQOL): Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment
    measure definition
    Health-related quality of life (HRQOL) evaluation was performed using the FACT-P questionnaire (Version 4). FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms. Baseline corresponded to last evaluable assessment before treatment administration.
    time frame
    Baseline, Day 1 of each Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8 and at End of Treatment (any time up to 141 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score indicated better
    population note
    Analysis was performed on HRQOL population which included participants who received at least one dose of the study drug and with an evaluable FACT-P questionnaire at baseline and at least one post-baseline evaluable FACT-P. Here 'Number analyzed' signifies participants with available data for each specified category.
    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-xtandi-532fb7f0
    nct id
    NCT02485691
    qol key
    qol-0012
    source section id
    NCT02485691-om-0012
    source outcome index
    12
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Utility Single Index and Visual Analogue Scale (VAS) Scores at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment
    measure definition
    EQ-5D was a standardized HRQOL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems \& severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS scale ranging from 0-100, where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. Baseline corresponded to last evaluable assessment before treatment administration.
    time frame
    Baseline, Day 1 of each Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8 and at End of Treatment (any time up to: 141 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher states indicated better
    population note
    Analysis was performed on Health status population which included participants who received at least one dose of the study drug and with an evaluable EQ-5D-5L at baseline and with at least one post-baseline evaluable EQ-5D-5L. Here 'Number analyzed' signifies participants with available data for each specified category.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

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