TriangleNCT01288911 · STUDY IN CONTEXT
A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
PFS is the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by the ICR, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first. Radiographic disease progression was defined as either a progression in soft tissue on computed tomography (CT)/magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan. A skeletal-related event was any radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain. The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started.
PFS was calculated as the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by investigators, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first. Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain. The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started.
The PSA response by Week 13 was defined as the percentage change from Baseline to the smallest PSA value after Baseline (i.e., a decrease of 100% represents the largest possible decrease to a value below the lower limit of quantification) and on or before day 99 (i.e., upper boundary of the Week 13 visit window). For participants with no decrease in PSA post-baseline by Week 13, the PSA response by Week 13 was the smallest increase in PSA up to day 99. For participants with no post-baseline PSA values up to day 99, the PSA response by Week 13 was set to missing. PSA was analyzed at a central laboratory.
The best PSA response was defined as the percentage change from Baseline to the smallest PSA value after Baseline including PSA results from samples taken after the study drug was stopped. For participants with no decrease in PSA post-baseline, the best PSA response was the smallest increase in PSA. For participants with no post-baseline PSA values, the PSA response was set to missing. PSA was analyzed at a central laboratory.
Time to PSA progression was calculated as the time interval from the date of randomization to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline value for participants who did not have a decline in PSA post-baseline values), and confirmed by a second consecutive PSA assessment at least 3 weeks later. For participants with no documented PSA progression, the time to PSA progression was censored on the date the last PSA sample was taken.
Time to PSA ≤ 4 ng/mL was defined as the time interval from the date of randomization to the first date a decline in PSA to a result of 4 ng/mL or below was recorded. In participants without PSA results ≤ 4 ng/mL, the time to PSA ≤ 4 ng/mL was censored on the date of the last PSA sample taken. Participants with a PSA result ≤ 4 ng/mL at Baseline, participants with no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- trial label
- A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0000
- source section id
- NCT01288911-om-0000
- source outcome index
- 0
- endpoint
- Progression Free Survival (PFS) Based on Independent Central Review (ICR) Assessment
- endpoint definition
- PFS is the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by the ICR, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first. Radiographic disease progression was defined as either a progression in soft tissue on computed tomography (CT)/magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan. A skeletal-related event was any radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain. The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started.
- time origin
- From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set (all randomized participants)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0001
- source section id
- NCT01288911-om-0001
- source outcome index
- 1
- endpoint
- PFS Based on Investigator Assessment
- endpoint definition
- PFS was calculated as the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by investigators, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first. Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain. The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started.
- time origin
- From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0002
- source section id
- NCT01288911-om-0002
- source outcome index
- 2
- endpoint
- Prostate-specific Antigen (PSA) Response by Week 13
- endpoint definition
- The PSA response by Week 13 was defined as the percentage change from Baseline to the smallest PSA value after Baseline (i.e., a decrease of 100% represents the largest possible decrease to a value below the lower limit of quantification) and on or before day 99 (i.e., upper boundary of the Week 13 visit window). For participants with no decrease in PSA post-baseline by Week 13, the PSA response by Week 13 was the smallest increase in PSA up to day 99. For participants with no post-baseline PSA values up to day 99, the PSA response by Week 13 was set to missing. PSA was analyzed at a central laboratory.
- time origin
- Baseline to Week 13
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set with available PSA data
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0003
- source section id
- NCT01288911-om-0003
- source outcome index
- 3
- endpoint
- Best PSA Response
- endpoint definition
- The best PSA response was defined as the percentage change from Baseline to the smallest PSA value after Baseline including PSA results from samples taken after the study drug was stopped. For participants with no decrease in PSA post-baseline, the best PSA response was the smallest increase in PSA. For participants with no post-baseline PSA values, the PSA response was set to missing. PSA was analyzed at a central laboratory.
- time origin
- Baseline to the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set with available PSA data
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0004
- source section id
- NCT01288911-om-0004
- source outcome index
- 4
- endpoint
- Time to PSA Progression
- endpoint definition
- Time to PSA progression was calculated as the time interval from the date of randomization to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline value for participants who did not have a decline in PSA post-baseline values), and confirmed by a second consecutive PSA assessment at least 3 weeks later. For participants with no documented PSA progression, the time to PSA progression was censored on the date the last PSA sample was taken.
- time origin
- From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0005
- source section id
- NCT01288911-om-0005
- source outcome index
- 5
- endpoint
- Time to PSA ≤ 4 ng/mL
- endpoint definition
- Time to PSA ≤ 4 ng/mL was defined as the time interval from the date of randomization to the first date a decline in PSA to a result of 4 ng/mL or below was recorded. In participants without PSA results ≤ 4 ng/mL, the time to PSA ≤ 4 ng/mL was censored on the date of the last PSA sample taken. Participants with a PSA result ≤ 4 ng/mL at Baseline, participants with no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization
- time origin
- From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 184
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 191
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 184
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 191
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 171
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 163
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 174
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 168
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 184
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 191
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 184
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- analyzed count
- 191
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01288911-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- harm key
- EG000
- source section id
- NCT01288911-ae
- event group key
- EG000
- event group label
- Double-blind Period: Enzalutamide
- serious affected
- 49
- serious at risk
- 141
- other affected
- 123
- other at risk
- 141
- frequency threshold
- 5
- collection period
- From initiation of study drug up to 30 days after the last dose of study drug or the 30-day safety follow-up visit, whichever occurred last. Median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm in the double-blind period. In the open-label period, the median duration of treatment was 21.6 months in participants who previously received enzalutamide and 20.9 months in participants who previously received bicalutamide.
- event definition
- The total number of deaths (all causes) includes deaths reported after the time frame above.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- harm key
- EG001
- source section id
- NCT01288911-ae
- event group key
- EG001
- event group label
- Double-blind Period: Bicalutamide
- serious affected
- 43
- serious at risk
- 180
- other affected
- 149
- other at risk
- 180
- frequency threshold
- 5
- collection period
- From initiation of study drug up to 30 days after the last dose of study drug or the 30-day safety follow-up visit, whichever occurred last. Median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm in the double-blind period. In the open-label period, the median duration of treatment was 21.6 months in participants who previously received enzalutamide and 20.9 months in participants who previously received bicalutamide.
- event definition
- The total number of deaths (all causes) includes deaths reported after the time frame above.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- harm key
- EG002
- source section id
- NCT01288911-ae
- event group key
- EG002
- event group label
- Open-label Period: Enzalutamide/Enzalutamide
- serious affected
- 18
- serious at risk
- 42
- other affected
- 42
- other at risk
- 42
- frequency threshold
- 5
- collection period
- From initiation of study drug up to 30 days after the last dose of study drug or the 30-day safety follow-up visit, whichever occurred last. Median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm in the double-blind period. In the open-label period, the median duration of treatment was 21.6 months in participants who previously received enzalutamide and 20.9 months in participants who previously received bicalutamide.
- event definition
- The total number of deaths (all causes) includes deaths reported after the time frame above.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01288911
- harm key
- EG003
- source section id
- NCT01288911-ae
- event group key
- EG003
- event group label
- Open-label Period: Bicalutamide/Enzalutamide
- serious affected
- 4
- serious at risk
- 9
- other affected
- 9
- other at risk
- 9
- frequency threshold
- 5
- collection period
- From initiation of study drug up to 30 days after the last dose of study drug or the 30-day safety follow-up visit, whichever occurred last. Median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm in the double-blind period. In the open-label period, the median duration of treatment was 21.6 months in participants who previously received enzalutamide and 20.9 months in participants who previously received bicalutamide.
- event definition
- The total number of deaths (all causes) includes deaths reported after the time frame above.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice