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← Bicalutamide: metastatic Carcinoma of the Prostate

NCT01308567 · STUDY IN CONTEXT

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

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

OS 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, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.

ITT population included all randomized participants.

→

secondary · POSTED

PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method.

ITT population included all randomized participants.

→

secondary · POSTED

Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method.

ITT population included all randomized participants.

→

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 ITT population. Number of participants analyzed=participants with measurable disease at baseline and at least one valid post-baseline value analyzed for specified outcome measure.

→

secondary · POSTED

Time to PSA-PFS: time interval between date of randomization \& first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA \<10 ng/mL):(a)in participants with baseline PSA\>0 ng/mL\&\<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.

Analysis was performed on ITT population which included all randomized participants.

→

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 in participants with baseline PSA value ≥10 ng/mL.

Analysis was performed on ITT population. Number of participants analyzed=participants with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value for specified outcome measure.

→

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

FACT · Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)

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-bicalutamide-e9e7e482
nct id
NCT01308567
qol key
qol-0009
source section id
NCT01308567-om-0009
source outcome index
9
instrument
FACT
instrument basis
matched 'fact-p' in the study's own wording
scale title
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)
measure definition
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.
time frame
Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicated better
population note
Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains. Here, 'number analyzed' = 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 →
FACT · Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL

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-bicalutamide-e9e7e482
nct id
NCT01308567
qol key
qol-0010
source section id
NCT01308567-om-0010
source outcome index
10
instrument
FACT
instrument basis
matched 'fact-p' in the study's own wording
scale title
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL
measure definition
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). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.
time frame
Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores representing a better
population note
Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains. Here, 'number analyzed' = 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-bicalutamide-e9e7e482
nct id
NCT01308567
trial label
Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer
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
3
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0000
    source section id
    NCT01308567-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS 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, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.
    time origin
    Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all randomized participants.
    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-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0001
    source section id
    NCT01308567-om-0001
    source outcome index
    1
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method.
    time origin
    Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all randomized participants.
    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-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0002
    source section id
    NCT01308567-om-0002
    source outcome index
    2
    endpoint
    Time to Tumor Progression Free Survival
    endpoint definition
    Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method.
    time origin
    Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all randomized participants.
    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-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0003
    source section id
    NCT01308567-om-0003
    source outcome index
    3
    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
    Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on ITT population. Number of participants analyzed=participants with measurable disease at baseline and at least one valid post-baseline value analyzed 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-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0004
    source section id
    NCT01308567-om-0004
    source outcome index
    4
    endpoint
    Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)
    endpoint definition
    Time to PSA-PFS: time interval between date of randomization \& first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA \<10 ng/mL):(a)in participants with baseline PSA\>0 ng/mL\&\<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.
    time origin
    Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on ITT population which included all randomized participants.
    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-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0005
    source section id
    NCT01308567-om-0005
    source outcome index
    5
    endpoint
    Percentage of Participants With 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 in participants with baseline PSA value ≥10 ng/mL.
    time origin
    Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on ITT population. Number of participants analyzed=participants with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value 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-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Docetaxel 75 mg/m^2
    regimen
    Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    391
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cabazitaxel 20 mg/m^2
    regimen
    Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    389
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Cabazitaxel 25 mg/m^2
    regimen
    Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    388
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Docetaxel 75 mg/m^2
    regimen
    Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    391
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Cabazitaxel 20 mg/m^2
    regimen
    Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    389
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Cabazitaxel 25 mg/m^2
    regimen
    Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    388
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Docetaxel 75 mg/m^2
    regimen
    Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    391
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Cabazitaxel 20 mg/m^2
    regimen
    Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    389
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Cabazitaxel 25 mg/m^2
    regimen
    Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    388
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Docetaxel 75 mg/m^2
    regimen
    Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Cabazitaxel 20 mg/m^2
    regimen
    Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    188
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Cabazitaxel 25 mg/m^2
    regimen
    Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    analyzed count
    173
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308567-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    harm key
    EG000
    source section id
    NCT01308567-ae
    event group key
    EG000
    event group label
    Docetaxel 75 mg/m^2
    serious affected
    126
    serious at risk
    387
    other affected
    353
    other at risk
    387
    frequency threshold
    5
    collection period
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 83 months) regardless of seriousness or relationship to investigational product.
    event definition
    Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug until 30 days after the last administration of study drug). Analysis was performed on safety population, which was randomized participants who received study drug and analyzed according to the treatment actually received.
    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-bicalutamide-e9e7e482
    nct id
    NCT01308567
    harm key
    EG001
    source section id
    NCT01308567-ae
    event group key
    EG001
    event group label
    Cabazitaxel 20 mg/m^2
    serious affected
    127
    serious at risk
    369
    other affected
    323
    other at risk
    369
    frequency threshold
    5
    collection period
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 83 months) regardless of seriousness or relationship to investigational product.
    event definition
    Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug until 30 days after the last administration of study drug). Analysis was performed on safety population, which was randomized participants who received study drug and analyzed according to the treatment actually received.
    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-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    harm key
    EG002
    source section id
    NCT01308567-ae
    event group key
    EG002
    event group label
    Cabazitaxel 25 mg/m^2
    serious affected
    188
    serious at risk
    391
    other affected
    354
    other at risk
    391
    frequency threshold
    5
    collection period
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 83 months) regardless of seriousness or relationship to investigational product.
    event definition
    Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug until 30 days after the last administration of study drug). Analysis was performed on safety population, which was randomized participants who received study drug and analyzed according to the treatment actually received.
    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-bicalutamide-e9e7e482
    nct id
    NCT01308567
    qol key
    qol-0009
    source section id
    NCT01308567-om-0009
    source outcome index
    9
    instrument
    FACT
    instrument basis
    matched 'fact-p' in the study's own wording
    scale title
    Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)
    measure definition
    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.
    time frame
    Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score indicated better
    population note
    Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains. Here, 'number analyzed' = 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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-bicalutamide-e9e7e482
    nct id
    NCT01308567
    qol key
    qol-0010
    source section id
    NCT01308567-om-0010
    source outcome index
    10
    instrument
    FACT
    instrument basis
    matched 'fact-p' in the study's own wording
    scale title
    Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL
    measure definition
    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). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.
    time frame
    Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores representing a better
    population note
    Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains. Here, 'number analyzed' = 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

    Preserved source evidence · Not medical advice