Prostate Cancer
Conditions
Brief summary
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.
Interventions
DRUGEnzalutamide
160 mg by mouth once daily
DRUGAbiraterone
1000 mg by mouth once daily
DRUGPlacebo for Enzalutamide
Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
DRUGPrednisone
5 mg by mouth twice daily
Sponsors
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men with metastatic castration-resistant prostate cancer * Progressive disease on androgen deprivation therapy * Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy * ECOG performance score ≤ 1 * Estimated life expectancy of ≥ 12 months
Exclusion criteria
* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer * Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo) * History of brain metastasis, active leptomeningeal disease or seizure * Severe cardiovascular or hepatic disease * Pituitary or adrenal dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (maximum up to 20.3 months) | PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor assessment date prior to data cutoff date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Use of New Antineoplastic Therapy for Prostate Cancer | From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months | It was defined as time from randomization to the date of first use of subsequent antineoplastic therapy for prostate cancer. For participants who had not started subsequent antineoplastic therapy as of data analysis cutoff date, the time to first use of subsequent antineoplastic therapy was censored at the date of last assessment. |
| Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89 | The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. |
| Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89 | The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms. |
| Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89 | The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. |
| Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | From randomization up to maximum of 18.4 months | Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation. |
| Time to Prostate Specific Antigen (PSA) Progression | From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months) | Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of \>=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date. |
| Prostate Specific Antigen (PSA) Response Rate | From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months) | PSA response rate was defined as percentage of participants with \>=30% and \>=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well. |
| Objective Response Rate (ORR) | From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months) | Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to \<10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: \>= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. |
| Rate of Pain Progression | Month 6 | Rate of pain progression was defined as percentage of participants with an increase of \>=30% from baseline in the mean Brief Pain Inventory-Short Form (BPI-SF) pain intensity item scores of 4 items assessing average, worst, least, and intermediate pain severity. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf score range for each item was from 0=no pain to 10=worst possible pain. Total score was reported as average of individual questions ranges from 0 to 10, where lower scores indicated less pain or less pain interference. |
| Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89 | The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life. |
| Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89 | The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life. |
| Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89 | The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) Leading to Death | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. |
| Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator. |
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious. |
| Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. |
Countries
Australia, Belgium, Denmark, Finland, France, Italy, Slovakia, Spain, Sweden, United Kingdom, United States
Participant flow
Pre-assignment details
Participants received enzalutamide in first open label treatment period. Participants in second open label treatment period could cross over to receive abiraterone and prednisone. In double blind period participants were randomized to receive treatment with enzalutamide or placebo, each in combination with abiraterone and prednisone.
Participants by arm
| Arm | Count |
|---|---|
| Enzalutamide 160 mg Participants received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first. | 509 |
| Total | 509 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1: First Open Label Treatment | Adverse Event | 40 | 0 | 0 | 0 |
| Period 1: First Open Label Treatment | Death | 14 | 0 | 0 | 0 |
| Period 1: First Open Label Treatment | Disease Progression | 92 | 0 | 0 | 0 |
| Period 1: First Open Label Treatment | Failure to Achieve PSA response at Week 13 | 43 | 0 | 0 | 0 |
| Period 1: First Open Label Treatment | Other | 34 | 0 | 0 | 0 |
| Period 1: First Open Label Treatment | Protocol Non-Compliance | 2 | 0 | 0 | 0 |
| Period 1: First Open Label Treatment | Withdrawal by Subject | 20 | 0 | 0 | 0 |
| Period 1: Second Open Label Treatment | Disease Progression | 0 | 11 | 0 | 0 |
| Period 1: Second Open Label Treatment | Other | 0 | 2 | 0 | 0 |
| Period 2: Double Blind Treatment | Adverse Event | 0 | 0 | 14 | 5 |
| Period 2: Double Blind Treatment | Death | 0 | 0 | 0 | 1 |
| Period 2: Double Blind Treatment | Disease Progression | 0 | 0 | 104 | 107 |
| Period 2: Double Blind Treatment | Other | 0 | 0 | 3 | 3 |
| Period 2: Double Blind Treatment | Protocol Non-Compliance | 0 | 0 | 0 | 1 |
| Period 2: Double Blind Treatment | Withdrawal by Subject | 0 | 0 | 5 | 8 |
Baseline characteristics
| Characteristic | Enzalutamide 160 mg |
|---|---|
| Age, Continuous | 72.3 years STANDARD_DEVIATION 8.31 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 509 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 32 / 509 | 1 / 13 | 14 / 126 | 10 / 125 |
| other Total, other adverse events | 474 / 509 | 13 / 13 | 113 / 125 | 113 / 124 |
| serious Total, serious adverse events | 163 / 509 | 4 / 13 | 47 / 125 | 37 / 124 |
Outcome results
Primary
Progression Free Survival (PFS)
PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor assessment date prior to data cutoff date.
Time frame: From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (maximum up to 20.3 months)
Population: ITT population included all participants randomly assigned to study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Progression Free Survival (PFS) | 5.7 months |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Progression Free Survival (PFS) | 5.6 months |
p-value: 0.217695% CI: [0.612, 1.119]Log Rank
Secondary
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life.
Time frame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Population: ITT population included all participants randomly assigned to study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 53 | 0.1 units on a scale | Standard Deviation 2.72 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 37 | -0.7 units on a scale | Standard Deviation 4.04 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 49 | 0.0 units on a scale | Standard Deviation 3 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 61 | -0.3 units on a scale | Standard Deviation 3.14 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 65 | -0.9 units on a scale | Standard Deviation 3.57 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 85 | -1.5 units on a scale | Standard Deviation 0.71 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Baseline | 18.1 units on a scale | Standard Deviation 3.8 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 13 | -0.1 units on a scale | Standard Deviation 3.55 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 17 | -0.2 units on a scale | Standard Deviation 3.44 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 21 | 0.3 units on a scale | Standard Deviation 3.48 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 25 | 0.3 units on a scale | Standard Deviation 2.58 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 29 | -0.5 units on a scale | Standard Deviation 3.56 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 33 | 0.1 units on a scale | Standard Deviation 3.33 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 41 | 0.1 units on a scale | Standard Deviation 2.99 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 45 | -0.5 units on a scale | Standard Deviation 3.23 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 9 | -0.1 units on a scale | Standard Deviation 2.81 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 57 | -0.4 units on a scale | Standard Deviation 2.32 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 69 | -0.5 units on a scale | Standard Deviation 2.93 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 73 | 1.0 units on a scale | Standard Deviation 2.83 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 77 | 0.1 units on a scale | Standard Deviation 2.67 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 81 | 1.5 units on a scale | Standard Deviation 3.54 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 89 | -3.0 units on a scale | — |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 53 | 1.2 units on a scale | Standard Deviation 3.23 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 61 | 1.1 units on a scale | Standard Deviation 3.62 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 33 | 0.9 units on a scale | Standard Deviation 2.99 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 65 | 2.9 units on a scale | Standard Deviation 2.54 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 77 | 2.0 units on a scale | Standard Deviation 2.83 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 37 | 0.9 units on a scale | Standard Deviation 2.49 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 69 | 1.5 units on a scale | Standard Deviation 2.93 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Baseline | 18.5 units on a scale | Standard Deviation 4.06 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 9 | 0.1 units on a scale | Standard Deviation 3.4 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 41 | 1.4 units on a scale | Standard Deviation 2.6 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 13 | 0.2 units on a scale | Standard Deviation 3.09 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 57 | 1.6 units on a scale | Standard Deviation 2.53 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 17 | 0.4 units on a scale | Standard Deviation 2.88 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 45 | 1.2 units on a scale | Standard Deviation 2.76 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 21 | 0.1 units on a scale | Standard Deviation 3.36 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 49 | 1.3 units on a scale | Standard Deviation 2.75 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 25 | 0.3 units on a scale | Standard Deviation 3.33 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 73 | -5.0 units on a scale | Standard Deviation 5.66 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores | Change at Week 29 | 0.3 units on a scale | Standard Deviation 3.27 |
Secondary
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.
Time frame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Population: ITT population included all participants randomly assigned to study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 45 | -2.0 units on a scale | Standard Deviation 3.37 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 29 | -2.4 units on a scale | Standard Deviation 4.67 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 49 | -2.1 units on a scale | Standard Deviation 4.55 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 53 | -1.6 units on a scale | Standard Deviation 4.67 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 57 | -1.4 units on a scale | Standard Deviation 4.06 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 81 | -1.5 units on a scale | Standard Deviation 7.78 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Baseline | 20.2 units on a scale | Standard Deviation 5.54 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 9 | -1.0 units on a scale | Standard Deviation 4.23 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 17 | -1.3 units on a scale | Standard Deviation 4 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 25 | -1.0 units on a scale | Standard Deviation 3.41 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 33 | -2.0 units on a scale | Standard Deviation 5.14 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 37 | -1.5 units on a scale | Standard Deviation 5.22 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 41 | -2.1 units on a scale | Standard Deviation 4.44 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 61 | -0.8 units on a scale | Standard Deviation 3.34 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 65 | -1.2 units on a scale | Standard Deviation 2.21 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 69 | 0.2 units on a scale | Standard Deviation 1.48 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 73 | -0.6 units on a scale | Standard Deviation 3.02 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 77 | -1.6 units on a scale | Standard Deviation 3.91 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 85 | -1.5 units on a scale | Standard Deviation 2.12 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 89 | 1.0 units on a scale | — |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 13 | -1.2 units on a scale | Standard Deviation 4.07 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 21 | -1.2 units on a scale | Standard Deviation 5.03 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 9 | -0.7 units on a scale | Standard Deviation 4.62 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 37 | 0.2 units on a scale | Standard Deviation 5.72 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 17 | -0.5 units on a scale | Standard Deviation 4.11 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 13 | -0.4 units on a scale | Standard Deviation 4.54 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 21 | -0.7 units on a scale | Standard Deviation 4.03 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 25 | -0.3 units on a scale | Standard Deviation 4.41 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 65 | 1.7 units on a scale | Standard Deviation 2.75 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 41 | 0.8 units on a scale | Standard Deviation 5.74 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Baseline | 20.3 units on a scale | Standard Deviation 5.84 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 29 | -0.2 units on a scale | Standard Deviation 4.38 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 53 | 1.3 units on a scale | Standard Deviation 4.92 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 45 | -0.3 units on a scale | Standard Deviation 6.28 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 57 | 2.0 units on a scale | Standard Deviation 4.37 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 61 | 2.9 units on a scale | Standard Deviation 5.56 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 69 | 2.3 units on a scale | Standard Deviation 4.23 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 73 | 4.0 units on a scale | Standard Deviation 12.73 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 77 | 2.5 units on a scale | Standard Deviation 9.19 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 33 | -0.7 units on a scale | Standard Deviation 4.49 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores | Change at Week 49 | 1.5 units on a scale | Standard Deviation 5.02 |
Secondary
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.
Time frame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Population: ITT population included all participants randomly assigned to study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 65 | -7.0 units on a scale | Standard Deviation 7.86 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 9 | -3.3 units on a scale | Standard Deviation 14.9 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 13 | -4.4 units on a scale | Standard Deviation 14.44 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 17 | -3.7 units on a scale | Standard Deviation 12.4 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 21 | -2.5 units on a scale | Standard Deviation 12.33 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 25 | -3.1 units on a scale | Standard Deviation 13.47 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 33 | -5.9 units on a scale | Standard Deviation 15.35 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 37 | -6.1 units on a scale | Standard Deviation 14.25 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 41 | -5.7 units on a scale | Standard Deviation 12.17 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 45 | -6.0 units on a scale | Standard Deviation 9.56 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 49 | -4.2 units on a scale | Standard Deviation 11.36 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 53 | -4.8 units on a scale | Standard Deviation 10.17 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 57 (n =17, 13) | -4.3 units on a scale | Standard Deviation 9.73 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 61 | -5.5 units on a scale | Standard Deviation 10.63 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 69 | -3.5 units on a scale | Standard Deviation 11.37 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 73 | -0.7 units on a scale | Standard Deviation 7.26 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 77 | -4.0 units on a scale | Standard Deviation 9.81 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 81 | 10.8 units on a scale | Standard Deviation 9.24 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 85 | -5.5 units on a scale | Standard Deviation 3.54 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 89 | -2.0 units on a scale | — |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 29 | -6.8 units on a scale | Standard Deviation 13.98 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Baseline | 116.4 units on a scale | Standard Deviation 20.1 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 25 | -2.1 units on a scale | Standard Deviation 10.87 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 61 | 0.6 units on a scale | Standard Deviation 12.94 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 45 | -2.6 units on a scale | Standard Deviation 16.27 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 53 | 1.8 units on a scale | Standard Deviation 14.68 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 41 | 1.3 units on a scale | Standard Deviation 14.13 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Baseline | 119.0 units on a scale | Standard Deviation 19.08 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 9 | -2.2 units on a scale | Standard Deviation 13.9 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 65 | 1.9 units on a scale | Standard Deviation 9.5 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 13 | -0.5 units on a scale | Standard Deviation 13.02 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 49 | 1.8 units on a scale | Standard Deviation 10.74 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 17 | -2.3 units on a scale | Standard Deviation 13.9 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 73 | -35.0 units on a scale | — |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 21 | -2.7 units on a scale | Standard Deviation 13.57 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 69 | 4.4 units on a scale | Standard Deviation 13.29 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 29 | 0.3 units on a scale | Standard Deviation 12.1 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 57 (n =17, 13) | 0.1 units on a scale | Standard Deviation 7.45 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 33 | -0.2 units on a scale | Standard Deviation 12.9 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 77 | 6.5 units on a scale | Standard Deviation 30.41 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | Change at Week 37 | 0.9 units on a scale | Standard Deviation 12.57 |
Secondary
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.
Time frame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Population: ITT population included all participants randomly assigned to study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 13 | -1.0 units on a scale | Standard Deviation 4.11 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Baseline | 22.9 units on a scale | Standard Deviation 4.5 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 9 | -0.8 units on a scale | Standard Deviation 4.04 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 29 | -2.5 units on a scale | Standard Deviation 4.89 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 17 | -1.1 units on a scale | Standard Deviation 3.26 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 21 | -0.8 units on a scale | Standard Deviation 3.11 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 25 | -1.7 units on a scale | Standard Deviation 4.23 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 37 | -1.8 units on a scale | Standard Deviation 4.5 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 41 | -1.5 units on a scale | Standard Deviation 3.94 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 45 | -2.0 units on a scale | Standard Deviation 3.72 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 49 | -0.9 units on a scale | Standard Deviation 3.78 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 53 | -0.2 units on a scale | Standard Deviation 3.78 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 57 | -0.4 units on a scale | Standard Deviation 3.25 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 61 | -0.8 units on a scale | Standard Deviation 3.11 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 65 | -1.9 units on a scale | Standard Deviation 4.25 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 69 | -0.3 units on a scale | Standard Deviation 4.08 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 73 | -0.3 units on a scale | Standard Deviation 2.05 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 77 | -0.7 units on a scale | Standard Deviation 2.81 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 85 | -1.0 units on a scale | Standard Deviation 0 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 89 | 0.0 units on a scale | — |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 33 | -2.5 units on a scale | Standard Deviation 5.37 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 81 | 1.5 units on a scale | Standard Deviation 2.12 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 29 | 0.3 units on a scale | Standard Deviation 2.67 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 37 | 0.4 units on a scale | Standard Deviation 3.13 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 53 | 0.7 units on a scale | Standard Deviation 2.85 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 57 | 0.4 units on a scale | Standard Deviation 2.37 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 69 | -0.5 units on a scale | Standard Deviation 2.67 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 41 | 0.4 units on a scale | Standard Deviation 2.8 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Baseline | 23.6 units on a scale | Standard Deviation 4.42 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 61 | 0.4 units on a scale | Standard Deviation 2.32 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 9 | 0.1 units on a scale | Standard Deviation 3.2 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 45 | -0.4 units on a scale | Standard Deviation 3.59 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 13 | 0.0 units on a scale | Standard Deviation 2.63 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 77 | 4.0 units on a scale | Standard Deviation 4.24 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 17 | -0.3 units on a scale | Standard Deviation 2.97 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 49 | 0.6 units on a scale | Standard Deviation 2.12 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 21 | -0.8 units on a scale | Standard Deviation 4.48 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 65 | 0.4 units on a scale | Standard Deviation 1.99 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 25 | -0.4 units on a scale | Standard Deviation 2.9 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 33 | 0.1 units on a scale | Standard Deviation 3.18 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores | Change at Week 73 | -3.0 units on a scale | Standard Deviation 5.66 |
Secondary
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms.
Time frame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Population: ITT population included all participants randomly assigned to study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 73 | -0.2 units on a scale | Standard Deviation 3.17 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 45 | -0.8 units on a scale | Standard Deviation 4.88 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 53 | -1.1 units on a scale | Standard Deviation 3.65 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Baseline | 33.2 units on a scale | Standard Deviation 6.85 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 9 | -0.7 units on a scale | Standard Deviation 5.97 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 13 | -1.9 units on a scale | Standard Deviation 5.91 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 17 | -1.0 units on a scale | Standard Deviation 5.36 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 21 | -0.4 units on a scale | Standard Deviation 5.13 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 25 | -0.8 units on a scale | Standard Deviation 6.93 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 29 | -1.3 units on a scale | Standard Deviation 5.75 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 33 | -1.4 units on a scale | Standard Deviation 5.16 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 49 | -0.8 units on a scale | Standard Deviation 4.26 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 57 | -0.5 units on a scale | Standard Deviation 3.67 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 61 | -2.1 units on a scale | Standard Deviation 4.29 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 65 | -2.0 units on a scale | Standard Deviation 4.05 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 69 | -1.5 units on a scale | Standard Deviation 3.3 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 77 | -1.0 units on a scale | Standard Deviation 3.71 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 81 | 3.1 units on a scale | Standard Deviation 1.22 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 85 | -0.5 units on a scale | Standard Deviation 0.71 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 89 | 0.0 units on a scale | — |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 37 | -1.5 units on a scale | Standard Deviation 4.88 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 41 | -1.0 units on a scale | Standard Deviation 5.13 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Baseline | 34.2 units on a scale | Standard Deviation 6.45 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 21 | -0.6 units on a scale | Standard Deviation 4.83 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 57 | -3.3 units on a scale | Standard Deviation 4.48 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 29 | -0.3 units on a scale | Standard Deviation 4.77 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 77 | -1.5 units on a scale | Standard Deviation 13.44 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 33 | -0.6 units on a scale | Standard Deviation 4.88 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 53 | -1.8 units on a scale | Standard Deviation 5.78 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 65 | -2.6 units on a scale | Standard Deviation 6.32 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 69 | 1.1 units on a scale | Standard Deviation 5.79 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 37 | -0.8 units on a scale | Standard Deviation 4.32 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 41 | -0.7 units on a scale | Standard Deviation 5.34 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 9 | -0.9 units on a scale | Standard Deviation 5.18 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 45 | -1.7 units on a scale | Standard Deviation 7.02 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 13 | -0.1 units on a scale | Standard Deviation 5.36 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 61 | -3.1 units on a scale | Standard Deviation 5.68 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 17 | -1.4 units on a scale | Standard Deviation 5.1 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 49 | -0.9 units on a scale | Standard Deviation 4.63 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 73 | -6.4 units on a scale | Standard Deviation 9.32 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores | Change at Week 25 | -0.8 units on a scale | Standard Deviation 4.42 |
Secondary
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life.
Time frame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Population: ITT population included all participants randomly assigned to study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 61 | -1.5 units on a scale | Standard Deviation 2.77 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Baseline | 22.1 units on a scale | Standard Deviation 5.8 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 9 | -0.5 units on a scale | Standard Deviation 4.33 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 13 | -0.4 units on a scale | Standard Deviation 3.46 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 17 | -0.1 units on a scale | Standard Deviation 3.68 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 21 | -0.5 units on a scale | Standard Deviation 3.24 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 25 | 0.1 units on a scale | Standard Deviation 2.79 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 29 | -0.1 units on a scale | Standard Deviation 3.2 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 33 | -0.2 units on a scale | Standard Deviation 3.21 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 37 | -0.8 units on a scale | Standard Deviation 3.04 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 41 | -1.4 units on a scale | Standard Deviation 3.75 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 45 | -0.9 units on a scale | Standard Deviation 3.36 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 49 | -0.6 units on a scale | Standard Deviation 2.88 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 53 | -1.0 units on a scale | Standard Deviation 3.15 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 57 | -2.0 units on a scale | Standard Deviation 3.06 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 65 | -1.5 units on a scale | Standard Deviation 2.54 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 69 | -1.4 units on a scale | Standard Deviation 2.03 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 73 | -0.6 units on a scale | Standard Deviation 3.22 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 81 | 6.2 units on a scale | Standard Deviation 5.42 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 85 | -1.0 units on a scale | Standard Deviation 1.41 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 77 | -0.9 units on a scale | Standard Deviation 3.41 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 89 | 0.0 units on a scale | — |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 57 | 0.2 units on a scale | Standard Deviation 1.29 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 37 | 0.8 units on a scale | Standard Deviation 2.79 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 61 | -0.2 units on a scale | Standard Deviation 1.8 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 41 | -0.1 units on a scale | Standard Deviation 3.51 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Baseline | 22.4 units on a scale | Standard Deviation 4.84 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 77 | -0.5 units on a scale | Standard Deviation 0.71 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 9 | -0.8 units on a scale | Standard Deviation 4.13 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 45 | -0.8 units on a scale | Standard Deviation 3.75 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 13 | -0.4 units on a scale | Standard Deviation 3.86 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 65 | -0.5 units on a scale | Standard Deviation 0.96 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 17 | -0.6 units on a scale | Standard Deviation 4.64 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 49 | 0.0 units on a scale | Standard Deviation 2.65 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 21 | -1.2 units on a scale | Standard Deviation 5.75 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 73 | -1.0 units on a scale | — |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 25 | -1.0 units on a scale | Standard Deviation 5.25 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 53 | 0.4 units on a scale | Standard Deviation 2.56 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 29 | -0.2 units on a scale | Standard Deviation 5.18 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 69 | -0.5 units on a scale | Standard Deviation 0.96 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores | Change at Week 33 | 0.0 units on a scale | Standard Deviation 4.95 |
Secondary
Objective Response Rate (ORR)
Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to \<10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: \>= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.
Time frame: From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)
Population: ITT population (with measurable disease at screening) included all participants randomly assigned to study treatment. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Objective Response Rate (ORR) | CR + PR | 0.0 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Objective Response Rate (ORR) | CR + PR + SD | 68.4 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Objective Response Rate (ORR) | CR + PR | 5.0 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Objective Response Rate (ORR) | CR + PR + SD | 57.5 percentage of participants |
Comparison: This analysis is reported for participants with CR+PR.p-value: 0.165395% CI: [-11.75, 1.75]Cochran-Mantel-Haenszel
Comparison: This analysis is reported for participants with CR+PR+SD.p-value: 0.321695% CI: [-10.37, 32.21]Cochran-Mantel-Haenszel
Secondary
Prostate Specific Antigen (PSA) Response Rate
PSA response rate was defined as percentage of participants with \>=30% and \>=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well.
Time frame: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
Population: Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Prostate Specific Antigen (PSA) Response Rate | >= 50% | 0.8 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Prostate Specific Antigen (PSA) Response Rate | >= 30% | 2.4 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Prostate Specific Antigen (PSA) Response Rate | >= 50% | 2.5 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Prostate Specific Antigen (PSA) Response Rate | >= 30% | 2.5 percentage of participants |
Comparison: This analysis is reported for participants with \>=50% decrease from baseline in PSA response.p-value: 0.310195% CI: [-4.82, 1.51]Cochran-Mantel-Haenszel
Comparison: This analysis is reported for participants with \>=30% decrease from baseline in PSA response.p-value: 0.991795% CI: [-3.9, 3.82]Cochran-Mantel-Haenszel
Secondary
Rate of Pain Progression
Rate of pain progression was defined as percentage of participants with an increase of \>=30% from baseline in the mean Brief Pain Inventory-Short Form (BPI-SF) pain intensity item scores of 4 items assessing average, worst, least, and intermediate pain severity. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf score range for each item was from 0=no pain to 10=worst possible pain. Total score was reported as average of individual questions ranges from 0 to 10, where lower scores indicated less pain or less pain interference.
Time frame: Month 6
Population: ITT population included all participants randomly assigned to study treatment. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Rate of Pain Progression | 36.2 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Rate of Pain Progression | 27.1 percentage of participants |
p-value: 0.296395% CI: [-7.69, 25.87]Cochran-Mantel-Haenszel
Secondary
Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.
Time frame: From randomization up to maximum of 18.4 months
Population: Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | 4.6 months |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score | 6.4 months |
p-value: 0.073995% CI: [0.967, 2.025]Log Rank
Secondary
Time to First Use of New Antineoplastic Therapy for Prostate Cancer
It was defined as time from randomization to the date of first use of subsequent antineoplastic therapy for prostate cancer. For participants who had not started subsequent antineoplastic therapy as of data analysis cutoff date, the time to first use of subsequent antineoplastic therapy was censored at the date of last assessment.
Time frame: From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months
Population: ITT population included all participants randomly assigned to study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Time to First Use of New Antineoplastic Therapy for Prostate Cancer | 10.3 months |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Time to First Use of New Antineoplastic Therapy for Prostate Cancer | 8.6 months |
p-value: 0.381895% CI: [0.616, 1.204]Log Rank
Secondary
Time to Prostate Specific Antigen (PSA) Progression
Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of \>=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date.
Time frame: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
Population: ITT population included all participants randomly assigned to study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Time to Prostate Specific Antigen (PSA) Progression | 2.8 months |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Time to Prostate Specific Antigen (PSA) Progression | 2.8 months |
p-value: 0.4595% CI: [0.617, 1.239]Log Rank
Other Pre-specified
Percentage of Participants With Adverse Events (AEs) Leading to Death
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.
Time frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
Population: Safety population included all participants who received any amount of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Death | 5.9 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Death | 0 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Death | 3.2 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Death | 2.4 percentage of participants |
Other Pre-specified
Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.
Time frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
Population: Safety population included all participants who received any amount of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Drug Discontinuation with Enzalutamide or Placebo | 11.8 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Drug Discontinuation with Prednisone | 7.7 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Drug Discontinuation with Abiraterone | 7.7 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Drug Discontinuation with Abiraterone | 23.2 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Drug Discontinuation with Prednisone | 16.0 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Drug Discontinuation with Enzalutamide or Placebo | 23.2 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Drug Discontinuation with Prednisone | 12.1 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Drug Discontinuation with Enzalutamide or Placebo | 11.3 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Drug Discontinuation with Abiraterone | 12.9 percentage of participants |
Other Pre-specified
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious.
Time frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
Population: Safety population included all participants who received any amount of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 32.0 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 93.5 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 100 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 30.8 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 37.6 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 91.2 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 29.8 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 92.7 percentage of participants |
Other Pre-specified
Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Time frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
Population: Safety population included all participants who received any amount of study drug. Number Analyzed signifies participants evaluable for the specified categories for respective arms.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | TEAEs related to Enzalutamide or Placebo | 66.6 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs related to Enzalutamide or Placebo | 4.1 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs related to Abiraterone | 0 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | TEAEs related to Prednisone | 7.7 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs related to Prednisone | 0 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | TEAEs related to Abiraterone | 38.5 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs related to Enzalutamide or Placebo | 7.2 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs related to Abiraterone | 7.2 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | TEAEs related to Abiraterone | 54.4 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs related to Prednisone | 2.4 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | TEAEs related to Enzalutamide or Placebo | 46.4 percentage of participants |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | TEAEs related to Prednisone | 36.0 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs related to Prednisone | 4.8 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | TEAEs related to Enzalutamide or Placebo | 36.3 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | TEAEs related to Abiraterone | 45.2 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | TEAEs related to Prednisone | 32.3 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs related to Enzalutamide or Placebo | 4.8 percentage of participants |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs related to Abiraterone | 4.0 percentage of participants |