TriangleNCT02677896 · STUDY IN CONTEXT
A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
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
rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline or week 13 according to PCWG2 criteria, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.
rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline for week 13 or the best response on treatment for week 25 or later assessments, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.
OS was defined as the time from randomization to death due to any cause. In participants still alive at the date of the analysis cutoff point, OS was censored on the last date the participant was known to be alive. OS was analyzed using Kaplan-Meier estimates.
Time to PSA progression was calculated as the time from the date of randomization to the first observation of PSA progression. A PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which was confirmed by a second consecutive value at least 3 weeks later. In participants with no PSA progression, time to PSA progression was censored on the date of the last PSA sample taken (or last value prior to 2 or more consecutive missed PSA assessments).
In participants with a new antineoplastic therapy initiated for prostate cancer after randomization, time to start of a new antineoplastic therapy was defined as the time interval from randomization to the date of the first dose administration of the first antineoplastic therapy. In participants with no new antineoplastic therapy initiated for prostate cancer after randomization, time to start of new antineoplastic therapy was censored on the last visit date or the date of randomization, whichever occurred last. Time to start of new antineoplastic therapy was analyzed using Kaplan-Meier estimates.
The PSA undetectable rate was defined as the percentage of participants with undetectable (\< 0.2 ng/mL) PSA values at any time during study treatment, of those participants with detectable (≥ 0.2 ng/mL) PSA values at baseline.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Time to Deterioration in Urinary Symptoms
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- qol key
- qol-0007
- source section id
- NCT02677896-om-0007
- source outcome index
- 7
- instrument
- EORTC QLQ
- instrument basis
- matched 'qlq' in the study's own wording
- scale title
- Time to Deterioration in Urinary Symptoms
- measure definition
- In participants with deterioration, the time to deterioration was calculated as the time interval between randomization and the first deterioration in urinary symptoms at any postbaseline visit. A deterioration in urinary symptoms was defined as an increase in the Quality of Life Prostate-specific Questionnaire (QLQ-PR25) modified urinary symptoms. Subscale score by ≥ 50% of the standard deviation observed in the QLQ-PR25 modified urinary symptoms subscale score at baseline. Modified urinary symptoms subscale score consisted of 3-items (Q31 - Q33) from the QLQ-PR25, each scored from 1 (not at all) to 4 (very much). The total modified urinary symptoms subscale score ranges from 0-100, with higher scores represents a higher level of symptomatology/problems. In participants without deterioration in urinary symptoms, the time to deterioration in urinary symptoms was censored on the date the last urinary symptoms QLQ-PR25 score was calculable.
- time frame
- From date of randomization to the first deterioration in urinary symptoms at any postbaseline visit (maximum duration was 26.6 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Time to Deterioration of Quality of Life (QoL) in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- qol key
- qol-0010
- source section id
- NCT02677896-om-0010
- source outcome index
- 10
- instrument
- FACT
- instrument basis
- matched 'fact-p' in the study's own wording
- scale title
- Time to Deterioration of Quality of Life (QoL) in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
- measure definition
- Time to deterioration of QoL was calculated as the time interval from the date of randomization to the first date a decline from baseline of 10 points or more in the FACT-P total score was recorded. The FACT-P consists of 27 core items that assess participant function in 4 domains and 12 prostate cancer-related items grouped into 5 subscales as follows: physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and prostate cancer subscale. Each item is rated on a 0 to 4 Likert-type scale. The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0 to 156), where high score represent better quality of life. In participants without FACT-P progression, the time to deterioration of QoL was censored on the date of the last FACT-P total score was calculable.
- time frame
- From the date of randomization to the first date a decline from baseline of 10 points or more in the FACT-P total score (maximum duration was 26.6 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Brief Pain Inventory · Time to Pain Progression Based on Brief Pain Inventory-Short Form (BPI-SF)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- qol key
- qol-0011
- source section id
- NCT02677896-om-0011
- source outcome index
- 11
- instrument
- Brief Pain Inventory
- instrument basis
- matched 'brief pain inventory' in the study's own wording
- scale title
- Time to Pain Progression Based on Brief Pain Inventory-Short Form (BPI-SF)
- measure definition
- Time to pain progression was defined as time from randomization to the first pain progression event. Pain progression was defined as an increase of ≥ 30% from baseline in the average BPI-SF pain severity score. BPI-SF contains 9 questions with rating scales from 0 (no pain/no interference) to 10 (worst pain/interferes completely). Total score was calculated as the average of each question. Higher scores represent a higher level of pain or interference. In participants with no pain progression event, time to pain progression was censored on the last visit date where BPI-SF was collected.
- time frame
- From randomization to the first pain progression event (maximum duration was 26.6 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- trial label
- A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
- 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
- 3
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0000
- source section id
- NCT02677896-om-0000
- source outcome index
- 0
- endpoint
- Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria
- endpoint definition
- rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline or week 13 according to PCWG2 criteria, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.
- time origin
- From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population is defined as all participants who were randomized in this study.
- 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-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0001
- source section id
- NCT02677896-om-0001
- source outcome index
- 1
- endpoint
- rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria
- endpoint definition
- rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline for week 13 or the best response on treatment for week 25 or later assessments, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.
- time origin
- From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT
- 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-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0002
- source section id
- NCT02677896-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival (OS)
- endpoint definition
- OS was defined as the time from randomization to death due to any cause. In participants still alive at the date of the analysis cutoff point, OS was censored on the last date the participant was known to be alive. OS was analyzed using Kaplan-Meier estimates.
- time origin
- From randomization to death due to any cause (maximum duration was 58.6 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population
- 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-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0003
- source section id
- NCT02677896-om-0003
- source outcome index
- 3
- endpoint
- Time to Prostate Specific Antigen (PSA) Progression
- endpoint definition
- Time to PSA progression was calculated as the time from the date of randomization to the first observation of PSA progression. A PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which was confirmed by a second consecutive value at least 3 weeks later. In participants with no PSA progression, time to PSA progression was censored on the date of the last PSA sample taken (or last value prior to 2 or more consecutive missed PSA assessments).
- time origin
- From the date of randomization to the first observation of PSA progression (maximum duration was 26.6 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT
- 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-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0004
- source section id
- NCT02677896-om-0004
- source outcome index
- 4
- endpoint
- Time to Start of New Antineoplastic Therapy
- endpoint definition
- In participants with a new antineoplastic therapy initiated for prostate cancer after randomization, time to start of a new antineoplastic therapy was defined as the time interval from randomization to the date of the first dose administration of the first antineoplastic therapy. In participants with no new antineoplastic therapy initiated for prostate cancer after randomization, time to start of new antineoplastic therapy was censored on the last visit date or the date of randomization, whichever occurred last. Time to start of new antineoplastic therapy was analyzed using Kaplan-Meier estimates.
- time origin
- From randomization to the date of the first dose administration of the first antineoplastic therapy (maximum duration was 58.6 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0005
- source section id
- NCT02677896-om-0005
- source outcome index
- 5
- endpoint
- PSA Undetectable Rate
- endpoint definition
- The PSA undetectable rate was defined as the percentage of participants with undetectable (\< 0.2 ng/mL) PSA values at any time during study treatment, of those participants with detectable (≥ 0.2 ng/mL) PSA values at baseline.
- time origin
- From baseline to detectable PSA values (maximum duration was 26.6 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT with detectable PSA at baseline
- 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-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Enzalutamide + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 574
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 576
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Enzalutamide + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 574
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 576
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Enzalutamide + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 574
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 576
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Enzalutamide + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 574
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 576
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Enzalutamide + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 574
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 576
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Enzalutamide + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 511
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo + Androgen Deprivation Therapy (ADT)
- regimen
- Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- analyzed count
- 506
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02677896-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- harm key
- EG000
- source section id
- NCT02677896-ae
- event group key
- EG000
- event group label
- Enzalutamide + Androgen Deprivation Therapy (ADT)
- serious affected
- 244
- serious at risk
- 572
- other affected
- 463
- other at risk
- 572
- frequency threshold
- 5
- collection period
- All-cause mortality: From randomization up to end of study duration (approximately 7 years) AEs: From first dose up to 30 days after last dose of study drug (maximum duration of treatment 7 years)
- event definition
- All-cause mortality: The at risk population included all randomized participants AEs: The at risk population included the Safety Analysis Set (SAF) consisting of all randomized 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- harm key
- EG001
- source section id
- NCT02677896-ae
- event group key
- EG001
- event group label
- Placebo + ADT
- serious affected
- 128
- serious at risk
- 574
- other affected
- 401
- other at risk
- 574
- frequency threshold
- 5
- collection period
- All-cause mortality: From randomization up to end of study duration (approximately 7 years) AEs: From first dose up to 30 days after last dose of study drug (maximum duration of treatment 7 years)
- event definition
- All-cause mortality: The at risk population included all randomized participants AEs: The at risk population included the Safety Analysis Set (SAF) consisting of all randomized 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- harm key
- EG002
- source section id
- NCT02677896-ae
- event group key
- EG002
- event group label
- Placebo Cross-over Enzalutamide
- serious affected
- 81
- serious at risk
- 182
- other affected
- 133
- other at risk
- 182
- frequency threshold
- 5
- collection period
- All-cause mortality: From randomization up to end of study duration (approximately 7 years) AEs: From first dose up to 30 days after last dose of study drug (maximum duration of treatment 7 years)
- event definition
- All-cause mortality: The at risk population included all randomized participants AEs: The at risk population included the Safety Analysis Set (SAF) consisting of all randomized 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- qol key
- qol-0007
- source section id
- NCT02677896-om-0007
- source outcome index
- 7
- instrument
- EORTC QLQ
- instrument basis
- matched 'qlq' in the study's own wording
- scale title
- Time to Deterioration in Urinary Symptoms
- measure definition
- In participants with deterioration, the time to deterioration was calculated as the time interval between randomization and the first deterioration in urinary symptoms at any postbaseline visit. A deterioration in urinary symptoms was defined as an increase in the Quality of Life Prostate-specific Questionnaire (QLQ-PR25) modified urinary symptoms. Subscale score by ≥ 50% of the standard deviation observed in the QLQ-PR25 modified urinary symptoms subscale score at baseline. Modified urinary symptoms subscale score consisted of 3-items (Q31 - Q33) from the QLQ-PR25, each scored from 1 (not at all) to 4 (very much). The total modified urinary symptoms subscale score ranges from 0-100, with higher scores represents a higher level of symptomatology/problems. In participants without deterioration in urinary symptoms, the time to deterioration in urinary symptoms was censored on the date the last urinary symptoms QLQ-PR25 score was calculable.
- time frame
- From date of randomization to the first deterioration in urinary symptoms at any postbaseline visit (maximum duration was 26.6 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT
- 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-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- qol key
- qol-0010
- source section id
- NCT02677896-om-0010
- source outcome index
- 10
- instrument
- FACT
- instrument basis
- matched 'fact-p' in the study's own wording
- scale title
- Time to Deterioration of Quality of Life (QoL) in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
- measure definition
- Time to deterioration of QoL was calculated as the time interval from the date of randomization to the first date a decline from baseline of 10 points or more in the FACT-P total score was recorded. The FACT-P consists of 27 core items that assess participant function in 4 domains and 12 prostate cancer-related items grouped into 5 subscales as follows: physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and prostate cancer subscale. Each item is rated on a 0 to 4 Likert-type scale. The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0 to 156), where high score represent better quality of life. In participants without FACT-P progression, the time to deterioration of QoL was censored on the date of the last FACT-P total score was calculable.
- time frame
- From the date of randomization to the first date a decline from baseline of 10 points or more in the FACT-P total score (maximum duration was 26.6 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT
- 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-abiraterone-acetate-159cbe11
- nct id
- NCT02677896
- qol key
- qol-0011
- source section id
- NCT02677896-om-0011
- source outcome index
- 11
- instrument
- Brief Pain Inventory
- instrument basis
- matched 'brief pain inventory' in the study's own wording
- scale title
- Time to Pain Progression Based on Brief Pain Inventory-Short Form (BPI-SF)
- measure definition
- Time to pain progression was defined as time from randomization to the first pain progression event. Pain progression was defined as an increase of ≥ 30% from baseline in the average BPI-SF pain severity score. BPI-SF contains 9 questions with rating scales from 0 (no pain/no interference) to 10 (worst pain/interferes completely). Total score was calculated as the average of each question. Higher scores represent a higher level of pain or interference. In participants with no pain progression event, time to pain progression was censored on the last visit date where BPI-SF was collected.
- time frame
- From randomization to the first pain progression event (maximum duration was 26.6 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice