TriangleNCT01212991 · STUDY IN CONTEXT
A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic 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
Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.
Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.
Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.
The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was censored on the date of randomization.
Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.
PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.
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-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- trial label
- A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic 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
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0000
- source section id
- NCT01212991-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival
- endpoint definition
- Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.
- time origin
- During study period (up to 3 years)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to Treat (ITT) - All patients randomly assigned to treatment.
- 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-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0001
- source section id
- NCT01212991-om-0001
- source outcome index
- 1
- endpoint
- Radiographic Progression-free Survival (rPFS)
- endpoint definition
- Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.
- time origin
- During study period (up to 20 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to Treat (ITT) - All patients randomly assigned to treatment excluding 84 patients who were not randomized before the radiographic Progression-free Survival data cutoff date of 06 May 2012.
- 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-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0002
- source section id
- NCT01212991-om-0002
- source outcome index
- 2
- endpoint
- Time to First Skeletal-related Event
- endpoint definition
- Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.
- time origin
- During study period (up to 3 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to Treat (ITT) - All patients randomly assigned to treatment.
- 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-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0003
- source section id
- NCT01212991-om-0003
- source outcome index
- 3
- endpoint
- Time to Initiation of Cytotoxic Chemotherapy
- endpoint definition
- The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was censored on the date of randomization.
- time origin
- During study period (up to 3 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to Treat (ITT) - All patients randomly assigned to treatment.
- 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-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0004
- source section id
- NCT01212991-om-0004
- source outcome index
- 4
- endpoint
- Time to Prostate-specific Antigen (PSA) Progression
- endpoint definition
- Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.
- time origin
- During study period (up to 3 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to Treat (ITT) - All patients randomized.
- 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-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0005
- source section id
- NCT01212991-om-0005
- source outcome index
- 5
- endpoint
- Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%
- endpoint definition
- PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.
- time origin
- During study period (up to 3 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable intent to treat (ITT) population - All patients randomly assigned to treatment with PSA values at baseline and at least one postbaseline assessment.
- 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-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
- analyzed count
- 872
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo, administered as four capsules, once per day by mouth.
- analyzed count
- 845
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
- analyzed count
- 832
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo, administered as four capsules, once per day by mouth.
- analyzed count
- 801
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
- analyzed count
- 872
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo, administered as four capsules, once per day by mouth.
- analyzed count
- 845
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
- analyzed count
- 872
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo, administered as four capsules, once per day by mouth.
- analyzed count
- 845
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
- analyzed count
- 872
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo, administered as four capsules, once per day by mouth.
- analyzed count
- 845
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Enzalutamide
- regimen
- Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
- analyzed count
- 854
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo, administered as four capsules, once per day by mouth.
- analyzed count
- 777
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01212991-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- harm key
- EG000
- source section id
- NCT01212991-ae
- event group key
- EG000
- event group label
- Enzalutamide
- serious affected
- 384
- serious at risk
- 871
- other affected
- 814
- other at risk
- 871
- frequency threshold
- 5
- collection period
- Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
- event definition
- Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
- 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-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- harm key
- EG001
- source section id
- NCT01212991-ae
- event group key
- EG001
- event group label
- Placebo
- serious affected
- 229
- serious at risk
- 844
- other affected
- 723
- other at risk
- 844
- frequency threshold
- 5
- collection period
- Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
- event definition
- Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
- 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-prostate-cancer-jevtana-f72c24a3
- nct id
- NCT01212991
- harm key
- EG002
- source section id
- NCT01212991-ae
- event group key
- EG002
- event group label
- Placebo Participants Crossover to Enzalutamide
- serious affected
- 104
- serious at risk
- 234
- other affected
- 180
- other at risk
- 234
- frequency threshold
- 5
- collection period
- Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
- event definition
- Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
- 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