TriangleNCT00887198 · STUDY IN CONTEXT
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Overall survival is defined as the time from randomization to date of death from any cause.
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.
The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.
The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.
The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at 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-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- trial label
- Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0000
- source section id
- NCT00887198-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival
- endpoint definition
- Overall survival is defined as the time from randomization to date of death from any cause.
- time origin
- From randomization (Day 1) up to end of study (Month 60)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat (ITT) population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
- 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-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0001
- source section id
- NCT00887198-om-0001
- source outcome index
- 1
- endpoint
- Radiographic Progression-free Survival (rPFS)
- endpoint definition
- The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
- time origin
- From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
- 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-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0002
- source section id
- NCT00887198-om-0002
- source outcome index
- 2
- endpoint
- Time to Opiate Use for Prostate Cancer Pain
- endpoint definition
- The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.
- time origin
- From randomization (Day 1) up to first opiate use or end of study (Month 60)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
- 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-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0003
- source section id
- NCT00887198-om-0003
- source outcome index
- 3
- endpoint
- Time to Initiation of Cytotoxic Chemotherapy
- endpoint definition
- The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.
- time origin
- From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
- 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-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0004
- source section id
- NCT00887198-om-0004
- source outcome index
- 4
- endpoint
- Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point
- endpoint definition
- The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.
- time origin
- From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
- 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-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0005
- source section id
- NCT00887198-om-0005
- source outcome index
- 5
- endpoint
- Time to Prostate-specific Antigen (PSA) Progression
- endpoint definition
- The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.
- time origin
- From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
- 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-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Abiraterone Acetate + Prednisone (AAP)
- regimen
- Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 546
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 542
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Abiraterone Acetate + Prednisone (AAP)
- regimen
- Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 546
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 542
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Abiraterone Acetate + Prednisone (AAP)
- regimen
- Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 546
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 542
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Abiraterone Acetate + Prednisone (AAP)
- regimen
- Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 546
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 542
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Abiraterone Acetate + Prednisone (AAP)
- regimen
- Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 546
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 542
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Abiraterone Acetate + Prednisone (AAP)
- regimen
- Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 546
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- analyzed count
- 542
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00887198-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- harm key
- EG000
- source section id
- NCT00887198-ae
- event group key
- EG000
- event group label
- Abiraterone Acetate + Prednisone (AAP)
- serious affected
- 215
- serious at risk
- 542
- other affected
- 530
- other at risk
- 542
- frequency threshold
- 5
- collection period
- From first dose of study drug up to 30 days after the last dose of study drug (Approximately 5 years)
- event definition
- Safety analysis set included all participants in the randomized population who received any 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-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- harm key
- EG001
- source section id
- NCT00887198-ae
- event group key
- EG001
- event group label
- Placebo
- serious affected
- 156
- serious at risk
- 540
- other affected
- 505
- other at risk
- 540
- frequency threshold
- 5
- collection period
- From first dose of study drug up to 30 days after the last dose of study drug (Approximately 5 years)
- event definition
- Safety analysis set included all participants in the randomized population who received any 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-prostate-cancer-pluvicto-59550568
- nct id
- NCT00887198
- harm key
- EG002
- source section id
- NCT00887198-ae
- event group key
- EG002
- event group label
- Placebo to AA
- serious affected
- 40
- serious at risk
- 93
- other affected
- 86
- other at risk
- 93
- frequency threshold
- 5
- collection period
- From first dose of study drug up to 30 days after the last dose of study drug (Approximately 5 years)
- event definition
- Safety analysis set included all participants in the randomized population who received any 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