TriangleNCT01946204 · STUDY IN CONTEXT
A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant 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
MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography \[CT\] or magnetic resonance imaging \[MRI\] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
Time to metastasis (TTM) was defined as the time from randomization to the time of the scan that showed first evidence of BICR-confirmed radiographically detected bone or soft tissue distant metastasis. The TTM data for participants without metastasis were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and CT or MRI of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
PFS defined as time from randomization to first documentation of BICR-confirmed radiographic progressive disease (PD) (development of distant/local/regional metastasis)/death due to any cause whichever occurred first. PFS data for participants without loco-regional disease were performed for US/ex-US regulatory purposes. Radiographic scans (bone scans and CT/MRI of chest,abdomen,pelvis) performed for detection of metastasis throughout study. PD based on RECIST v1.1; Subjects with one measurable lesion, At least 20% increase in sum of diameters of target lesions taking as reference smallest sum on study. In addition, sum must demonstrate an absolute increase of at least 5 millimeter(mm). Also, appearance of one/more new lesions was also considered PD. Subjects with non-measurable disease as per CT/MRI scans, unequivocal progression/appearance of one or more new lesions was considered PD. For new bone lesions detected on bone scans, second imaging (CT/MRI) was required to confirm PD.
Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following (whichever occurred earlier): a) development of a skeletal-related event (pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone); b) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c) development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.
Overall survival was defined as the time from randomization to the date of death due to any cause.
Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
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
- NCT01946204
- trial label
- A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0005
- source section id
- NCT01946204-om-0005
- source outcome index
- 5
- endpoint
- Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)
- endpoint definition
- MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography \[CT\] or magnetic resonance imaging \[MRI\] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
- time origin
- Up to approximately 43 Months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat (ITT) population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
- 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
- NCT01946204
- outcome key
- om-0000
- source section id
- NCT01946204-om-0000
- source outcome index
- 0
- endpoint
- Time to Metastasis (TTM)
- endpoint definition
- Time to metastasis (TTM) was defined as the time from randomization to the time of the scan that showed first evidence of BICR-confirmed radiographically detected bone or soft tissue distant metastasis. The TTM data for participants without metastasis were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and CT or MRI of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
- time origin
- Up to approximately 43 Months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
- 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
- NCT01946204
- outcome key
- om-0001
- source section id
- NCT01946204-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- PFS defined as time from randomization to first documentation of BICR-confirmed radiographic progressive disease (PD) (development of distant/local/regional metastasis)/death due to any cause whichever occurred first. PFS data for participants without loco-regional disease were performed for US/ex-US regulatory purposes. Radiographic scans (bone scans and CT/MRI of chest,abdomen,pelvis) performed for detection of metastasis throughout study. PD based on RECIST v1.1; Subjects with one measurable lesion, At least 20% increase in sum of diameters of target lesions taking as reference smallest sum on study. In addition, sum must demonstrate an absolute increase of at least 5 millimeter(mm). Also, appearance of one/more new lesions was also considered PD. Subjects with non-measurable disease as per CT/MRI scans, unequivocal progression/appearance of one or more new lesions was considered PD. For new bone lesions detected on bone scans, second imaging (CT/MRI) was required to confirm PD.
- time origin
- Up to approximately 43 Months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
- 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
- NCT01946204
- outcome key
- om-0002
- source section id
- NCT01946204-om-0002
- source outcome index
- 2
- endpoint
- Time to Symptomatic Progression
- endpoint definition
- Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following (whichever occurred earlier): a) development of a skeletal-related event (pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone); b) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c) development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.
- time origin
- Up to approximately 43 Months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
- 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
- NCT01946204
- outcome key
- om-0003
- source section id
- NCT01946204-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival
- endpoint definition
- Overall survival was defined as the time from randomization to the date of death due to any cause.
- time origin
- Up to approximately 43 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
- 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
- NCT01946204
- outcome key
- om-0004
- source section id
- NCT01946204-om-0004
- source outcome index
- 4
- endpoint
- Time to Initiation of Cytotoxic Chemotherapy
- endpoint definition
- Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
- time origin
- Up to approximately 43 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
- 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
- NCT01946204
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 401
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Apalutamide
- regimen
- Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 806
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 401
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Apalutamide
- regimen
- Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 806
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 401
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Apalutamide
- regimen
- Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 806
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 401
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Apalutamide
- regimen
- Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 806
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 401
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Apalutamide
- regimen
- Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 806
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 401
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Apalutamide
- regimen
- Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- analyzed count
- 806
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01946204-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT01946204
- harm key
- EG000
- source section id
- NCT01946204-ae
- event group key
- EG000
- event group label
- Placebo
- serious affected
- 92
- serious at risk
- 398
- other affected
- 329
- other at risk
- 398
- frequency threshold
- 5
- collection period
- Up to approximately 43 months
- event definition
- Safety population included all participants who received at least one dose of study drug.
- 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
- NCT01946204
- harm key
- EG001
- source section id
- NCT01946204-ae
- event group key
- EG001
- event group label
- Apalutamide
- serious affected
- 199
- serious at risk
- 803
- other affected
- 716
- other at risk
- 803
- frequency threshold
- 5
- collection period
- Up to approximately 43 months
- event definition
- Safety population included all participants who received at least one dose of study drug.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice