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← ERLEADA: metastatic Prostate Cancer

NCT01308580 · STUDY IN CONTEXT

Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of 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 absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method.

Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants.

→

secondary · POSTED

PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA \>0 ng/mL \& \<10 ng/mL; or post-baseline value of \>=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method.

Analysis was performed on ITT population.

→

secondary · POSTED

Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method.

Analysis was performed on ITT population.

→

secondary · POSTED

Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. 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 had 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 evaluable for tumor response with measurable disease at baseline and at least one valid post-baseline value.

→

secondary · POSTED

Time to PSA progression was time interval between randomization \& first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (\>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve \>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA \<10 ng/mL): (a) participants with baseline PSA \>0 ng/mL \& \<10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method.

Analysis was performed on ITT population.

→

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 evaluable for PSA response with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value.

→

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):Trial Outcome Index (TOI) 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-erleada-885f8496
nct id
NCT01308580
qol key
qol-0008
source section id
NCT01308580-om-0008
source outcome index
8
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 Health Related Quality of Life (HRQoL)
measure definition
FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists 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 TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL.
time frame
Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher values represent better
population note
FACT-P population included randomized participants who completed FACT-P questionnaire at baseline \& in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, 'n' signifies number of participants with available data for 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 FACT-P:Total Score 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-erleada-885f8496
nct id
NCT01308580
qol key
qol-0009
source section id
NCT01308580-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 FACT-P:Total Score as a Measure of HRQoL
measure definition
FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists 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 sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL.
time frame
Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher values represent better
population note
Analysis was performed on FACT-P population. Number of participants analyzed=participants with evaluable FACT-P Total Score for specified outcome measure. Here, 'n' signifies number of participants with available data for 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 · Percentage of Participants With FACT-P Total Score Response

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-erleada-885f8496
nct id
NCT01308580
qol key
qol-0010
source section id
NCT01308580-om-0010
source outcome index
10
instrument
FACT
instrument basis
matched 'fact-p' in the study's own wording
scale title
Percentage of Participants With FACT-P Total Score Response
measure definition
FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists 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 sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period.
time frame
From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher values represent better
population note
Analysis was performed on FACT-P population. Number of participants analyzed= participants with evaluable FACT-P total score 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 →
FACT · Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales

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-erleada-885f8496
nct id
NCT01308580
qol key
qol-0011
source section id
NCT01308580-om-0011
source outcome index
11
instrument
FACT
instrument basis
matched 'fact-p' in the study's own wording
scale title
Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales
measure definition
The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method.
time frame
From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Analysis was performed on FACT-P population.
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-erleada-885f8496
nct id
NCT01308580
trial label
Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of 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
2
qol Count
4
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0000
    source section id
    NCT01308580-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 absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method.
    time origin
    From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on Intent-to-Treat (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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0001
    source section id
    NCT01308580-om-0001
    source outcome index
    1
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA \>0 ng/mL \& \<10 ng/mL; or post-baseline value of \>=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method.
    time origin
    From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    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-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0002
    source section id
    NCT01308580-om-0002
    source outcome index
    2
    endpoint
    Time to Tumor Progression
    endpoint definition
    Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method.
    time origin
    From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    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-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0003
    source section id
    NCT01308580-om-0003
    source outcome index
    3
    endpoint
    Percentage of Participants With Overall Objective Tumor Response
    endpoint definition
    Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. 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 had 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 baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for tumor response with measurable disease at baseline and at least one valid post-baseline value.
    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-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0004
    source section id
    NCT01308580-om-0004
    source outcome index
    4
    endpoint
    Time to PSA Progression
    endpoint definition
    Time to PSA progression was time interval between randomization \& first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (\>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve \>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA \<10 ng/mL): (a) participants with baseline PSA \>0 ng/mL \& \<10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method.
    time origin
    From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0005
    source section id
    NCT01308580-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
    From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for PSA response with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value.
    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-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cabazitaxel 20 mg/m^2
    regimen
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    598
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cabazitaxel 25 mg/m^2
    regimen
    Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    602
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cabazitaxel 20 mg/m^2
    regimen
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    598
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Cabazitaxel 25 mg/m^2
    regimen
    Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    602
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cabazitaxel 20 mg/m^2
    regimen
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    598
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Cabazitaxel 25 mg/m^2
    regimen
    Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    602
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Cabazitaxel 20 mg/m^2
    regimen
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    271
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Cabazitaxel 25 mg/m^2
    regimen
    Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    256
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Cabazitaxel 20 mg/m^2
    regimen
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    598
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Cabazitaxel 25 mg/m^2
    regimen
    Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    602
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Cabazitaxel 20 mg/m^2
    regimen
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    543
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Cabazitaxel 25 mg/m^2
    regimen
    Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    analyzed count
    538
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01308580-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-erleada-885f8496
    nct id
    NCT01308580
    harm key
    EG000
    source section id
    NCT01308580-ae
    event group key
    EG000
    event group label
    Cabazitaxel 20 mg/m^2
    serious affected
    177
    serious at risk
    580
    other affected
    450
    other at risk
    580
    frequency threshold
    5
    collection period
    All AEs were collected from signature of the informed consent form up to the final visit (48 months) regardless of seriousness or relationship to investigational product.
    event definition
    Reported AEs are TEAEs 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.
    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-erleada-885f8496
    nct id
    NCT01308580
    harm key
    EG001
    source section id
    NCT01308580-ae
    event group key
    EG001
    event group label
    Cabazitaxel 25 mg/m^2
    serious affected
    257
    serious at risk
    595
    other affected
    507
    other at risk
    595
    frequency threshold
    5
    collection period
    All AEs were collected from signature of the informed consent form up to the final visit (48 months) regardless of seriousness or relationship to investigational product.
    event definition
    Reported AEs are TEAEs 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.
    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-erleada-885f8496
    nct id
    NCT01308580
    qol key
    qol-0008
    source section id
    NCT01308580-om-0008
    source outcome index
    8
    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 Health Related Quality of Life (HRQoL)
    measure definition
    FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists 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 TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL.
    time frame
    Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher values represent better
    population note
    FACT-P population included randomized participants who completed FACT-P questionnaire at baseline \& in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, 'n' signifies number of participants with available data for 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-erleada-885f8496
    nct id
    NCT01308580
    qol key
    qol-0009
    source section id
    NCT01308580-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 FACT-P:Total Score as a Measure of HRQoL
    measure definition
    FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists 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 sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL.
    time frame
    Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher values represent better
    population note
    Analysis was performed on FACT-P population. Number of participants analyzed=participants with evaluable FACT-P Total Score for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category.
    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-erleada-885f8496
    nct id
    NCT01308580
    qol key
    qol-0010
    source section id
    NCT01308580-om-0010
    source outcome index
    10
    instrument
    FACT
    instrument basis
    matched 'fact-p' in the study's own wording
    scale title
    Percentage of Participants With FACT-P Total Score Response
    measure definition
    FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists 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 sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period.
    time frame
    From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher values represent better
    population note
    Analysis was performed on FACT-P population. Number of participants analyzed= participants with evaluable FACT-P total score for specified outcome measure.
    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-erleada-885f8496
    nct id
    NCT01308580
    qol key
    qol-0011
    source section id
    NCT01308580-om-0011
    source outcome index
    11
    instrument
    FACT
    instrument basis
    matched 'fact-p' in the study's own wording
    scale title
    Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales
    measure definition
    The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method.
    time frame
    From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Analysis was performed on FACT-P population.
    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