Prostate Cancer
Conditions
Keywords
Mineralocorticoid Excess ; Chemotherapy-Naïve; Metastatic Castration-Resistant Prostate Cancer; Abiraterone Acetate; Zytiga; Prednisone; dexamethasone
Brief summary
The purpose of the study is to determine the safety and clinical benefit of the combinations of abiraterone acetate and prednisone or abiraterone and dexamethasone in prostate cancer patients. Prednisone will be given at one of three different dose schedules. Dexamethasone will be given at one dose schedule. This will include looking at what side effects occur and how often they occur. In addition the impact of the study drug on quality of life and pain will be evaluated. The study will also collect data on subsequent treatment of patients after they come off the study drug (approximately 4.5 years after the start of study treatment of the first subject participating in the study). By analyzing blood samples, the study aims to identify if some markers could help to understand if the treatment with abiraterone is effective and also help to understand if patients can become resistant.
Detailed description
This is a randomized (study drug is assigned by chance), open-label (all people know the identity of the intervention), parallel-arm, multicenter, phase 2 study of treatment with abiraterone acetate (AA) and 4 alternative steroid treatment strategies in asymptomatic, chemotherapy-naïve, mCRPC patients. A target of 144 patients will be enrolled in this study with 36 patients planned per treatment arm. All patients participating in this study will receive abiraterone acetate. All patients will also take either prednisone or dexamethasone. Patients will receive abiraterone acetate along with either prednisone at one of three different dose schedules or with dexamethasone at one dose schedule. Patients may also be asked to take a medication to protect from osteoporosis as this can be increased by long term use of corticosteroids. There are 4 treatment groups in this study: (a) Four 250 mg tablets of abiraterone acetate taken together once daily and one 2.5 mg tablet of prednisone taken twice daily; (b) Four 250 mg tablets of abiraterone acetate taken together once daily and one 5 mg tablet of prednisone taken once daily; (c) Four 250mg tablets of abiraterone acetate taken together once daily and one 5 mg tablet of prednisone taken twice daily; (d) Four 250 mg tablets of abiraterone acetate taken together once daily and one 0.5 mg tablet of dexamethasone taken once daily. The chance that patients will get prednisone is 3 out of 4 patients. The chance that they will get dexamethasone is 1 out of 4 patients. Abiraterone acetate, prednisone and dexamethasone will be considered as study drugs. The main study will consist of a screening phase of 4 weeks followed by an open-label treatment period of a maximum of 39 treatment cycles (156 weeks or approximately 3 years). The main study treatment period cut-off date will be 156 weeks after the start of study treatment for the first patient participating in the study. Patients will participate in the main study treatment period until the cut-off date, and will receive study treatment until radiographic disease progression and/or unequivocal clinical progression and/or other specific reasons for discontinuation of treatment. Patients will be asked if they would be willing to participate in a follow-up or extension phase of the study for approximately 4.5 years after the start of study treatment of the first subject participating in the study. The amount of time patients will be in the study will vary depending when they join the study and time remaining to the study end date and on their response to the treatment. Patients may come off the study drug if their cancer worsens, if they are unable to tolerate the study treatment, if their doctor determines that they should begin another cancer treatment, or if they decide to withdraw consent. A treatment cycle in this study is the amount of time a patient will be asked to take the study medication, and have regularly pre-scheduled checkups and laboratory assessments. Each treatment-cycle will last 28 days. There are a maximum of 39 treatment cycles in this study (over a period of 156 weeks). If patients enter the extension phase, they will be asked to attend hospital every 12 weeks for the remaining time that they stay on the study. Other anticancer therapy or immunotherapy must be ended before and while participating in this clinical study with abiraterone acetate. Also some medications are not allowed during the study. For example, if patients are receiving a steroid other than prednisone, it will be necessary to switch it to prednisone or dexamethasone, depending on to which treatment group patients have been assigned, for the duration of the study. If needed, their study doctor may slowly decrease and stop some or all of their current medicines before the study treatment starts. This is called washout. Do not stop taking any of their current medicine unless their study doctor tells patients to do so. At screening the study doctor will first check that patients are qualified. Screening procedures will be conducted within 4 weeks before randomization. During the main study treatment phase patients will come to the study clinic for Study Visits about 21 times in total (including for screening) if they stay on treatment for 39 cycles. During Cycle 1 of this study, patients will be asked to come to the clinic three times for assessments: on Day 1 which also will usually be their first day of treatment, Day 15 and two weeks later. After that patients will need to return to the clinic once every four weeks for the first 6 months. After that, the visits are once every 3 months for assessments. In addition, patients will need to visit either the clinic or the Outpatients every 2 weeks for the first 3 months and every 4 weeks after that to the end of their treatment to provide a small quantity of blood for testing. If patients either continue study treatment to 39 cycles, or if patients discontinue from the study before 39 treatment cycles, their last visit with drug dispensed will be called an End-of-main-study-treatment (EOMT) visit. EOMT assessments will be performed for all patients who started study treatment, either at the cut-off date or when they discontinue before the cut-off date. Additionally, for patients discontinuing study treatment before the cut-off date, an end-of-main-study (EOMS) visit will be performed 4 weeks after study medication is stopped. Patients will also be required to return to the study site 4 weeks after their last treatment for the End of Main Study visit as below. This visit is for some routine study assessments. During the extension phase, patients will be provided with study drug outside of the main study for approximately 4.5 years after the start of study treatment of the first subject participating in the study. During this phase, patients will receive study drug during their 12 weekly visits and their doctor will check on their health status at the same time. Patients will not be required to provide blood or urine samples during this phase. Patients are likely to be eligible to join this extension phase if patients have responded well to the study drug and have not been discontinued from the main study. Also even if they have discontinued from the main study, if they have had no disease progression their doctor may advise them that they are eligible to join this phase. Their last visit will be called an End of Extension visit. For this visit, patients will be required to return to the study site 4 weeks after their last treatment for some final assessments. Follow-Up: Following discontinuation of study treatment at any time during the study, for any reason other than withdrawal of consent, survival and subsequent prostate cancer therapies will be monitored approximately 4.5 years after the start of study treatment of the first subject participating in the study. This information will be obtained by 6-monthly telephone contact and/or chart review, with a source data verification visit scheduled after the death of the patient or at the end of the study. Their doctor may phone them or their family to ask about their health status during this approximately 4.5 years of period if he/she feels that their chart records may need to be updated. A Scientific Advisory Committee will be commissioned to ensure scientific validity of this study, to identify any scientifically relevant trends, and to provide recommendations to the sponsor.
Interventions
DRUGAbiraterone Acetate
Type = exact number; unit = mg; number = 1000; form = tablet; route = oral; taken as four 250 mg tablets once daily at least 2 hours after eating and no food should be eaten for at least 1 hour after taking the tablets.
DRUGPrednisone 5 mg twice daily
type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken twice daily, the first dose in the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon or early evening, after a meal
DRUGPrednisone 5 mg once daily
type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken once daily, in the morning after a meal
DRUGPrednisone 2.5 mg twice daily
type = exact number; unit = mg; number = 2.5; form = tablet; route = oral; taken twice daily, the first dose in the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon or early evening, after a meal
DRUGDexamethasone 0.5 mg once daily
type = exact number; unit = mg; number = 0.5; form = tablet; route = oral; taken once daily, in the morning after breakfast
Sponsors
Janssen Pharmaceutica N.V., Belgium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Have a histologically or cytologically confirmed adenocarcinoma of the prostate Have metastatic disease documented by positive bone scan or by computed tomography or magnetic resonance imaging Have prostate cancer progression documented by prostate specific antigen according to Prostate Cancer Working Group 2 or radiographic progression according to modified RECIST (response evaluation criteria in solid tumors, v1.1) criteria Be asymptomatic from prostate cancer. A score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours) will be considered asymptomatic Be surgically or medically castrated, with testosterone levels of \<50 ng/dL (\<2.0 nmol/L). If the subject is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (subjects who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Day 1, Cycle 1 and must be continued throughout the study.
Exclusion criteria
Has a history of pituitary or adrenal dysfunction Has an active infection or other medical condition that would contraindicate corticosteroid use Has any chronic medical condition requiring corticosteroid treatment or has received prior corticosteroid treatment for prostate cancer Has a pathological finding consistent with small cell carcinoma of the prostate Has a known brain metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment | Week 24 | No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of main study treatment period [MSTP]) | BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (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 scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Worst pain item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine. Last observation carried forward (LOCF) approach used for endpoint analysis. Last observation defined as last visit with non-missing data for parameter analyzed. |
| Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) | BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (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 scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-SF; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed. |
| Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) | BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (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 scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Interference Index is the mean of the scores for the 7 items of the BPI-SF; range is 0=Does not interfere to 10=Completely interferes. LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed. |
| Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) | EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed. |
| Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) | EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed. |
| Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) | FACT-P is a 39-item participant rated questionnaire which consists of 5 subscales assessing physical well-being (7 items; score range 0-28), social/family well-being (7 items; score range 0-28), emotional well-being (6 items; score range 0-24), functional well-being (7 items; score range 0-28), prostate-specific concerns (12 items; score range 0-48). Each item rated on 0 to 4 Likert type scale, then combined to produce subscale scores for each domain, as well as global quality of life (QoL) score that ranges from 0 to 156. Higher scores represent better QoL. Additional Concerns subscale has 12 items, each with a score 0-6 making a total subscale range 0-72 (higher scores are better). Missing data imputed as per FACT-P Ver4 scoring system (sum of item scores\*number of items in subscale/number of items answered). |
| Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12 | Week 12 | The PSA response is defined as a \>= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2) criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show \>=50% decline from baseline. |
| Time to Prostate-Specific Antigen (PSA) Progression | Up to 156 weeks | Time to PSA progression was defined as time interval from the date of randomization to the date of the first prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group 2 (PSAWG2) criteria during the main study treatment period. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. |
| Objective Response Rate (ORR) | Up to 4.9 years | ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions , any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 millimetre \[mm\] short axis). PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. |
| Time to Opiate Use for Cancer-related Pain | Up to 156 weeks | Time to opiate use for cancer-related pain is defined the time interval from the date of randomization to the first date of opiate use for cancer pain. |
| Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point | Up to 156 weeks | Time to deterioration in ECOG Performance Status, the time interval from the date of randomization to the first date in which at least one point change (worsening) in the ECOG is observed during the main study treatment period. The ECOG performance status is a grade scale to measure quality of life (QoL). Scores run from 0 to 5, with 0 denoting perfect health and 5 denoting death. |
| Overall Survival | Up to 156 weeks | Overall survival was defined as the time interval from the date of randomization to the date of death from any cause. |
| Time to Next Prostate Cancer Therapy | Up to 4.9 years | Time to next prostate cancer therapy is defined as the time interval from the date of randomization to the date of initiation of first next therapy for prostate cancer. |
| Progression-Free Survival (PFS) | Up to 4.9 years | PFS: Time from randomization to one of following: radiographic progression (RP), clinical progression (CP) or death. RP- per PCWG2 criteria and modified RECIST as time from randomization to one of following: 1) considered to have progressed by bone scan if: a) first scan with \>=2 new lesions compared to baseline at \<12 weeks from randomization and confirmed by second scan \>=6 weeks later with \>=2 additional new lesions, b) first scan with \>=2 new lesions compared to baseline at \>=12 weeks from randomization and new lesions on next bone scan \>=6 weeks later; 2) Progression of soft tissue lesions per modified RECIST; CP: cancer pain requiring initiation of chronic use of opiate analgesia (oral use for \>=3 weeks; parenteral use for \>=7 days), Or immediate need to initiate cytotoxic chemotherapy or either radiation therapy or surgical intervention for complications due to tumor progression, even in absence of RP, Or deterioration in ECOG performance status to grade 3 or above. |
Countries
Belgium, Germany, Hungary, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study. | 41 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study. | 41 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study. | 40 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study. | 42 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Biochemical progression | 0 | 1 | 0 | 0 |
| Overall Study | Clinical progression | 0 | 0 | 1 | 0 |
| Overall Study | Death | 25 | 15 | 27 | 20 |
| Overall Study | Disease progression | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 4 | 3 | 2 |
| Overall Study | Patient decision | 0 | 0 | 0 | 1 |
| Overall Study | Patient to follow subsequent treatment | 0 | 1 | 0 | 0 |
| Overall Study | Progressive disease | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | PSA-progression | 0 | 1 | 0 | 0 |
| Overall Study | Study medication no longer effective | 0 | 1 | 0 | 0 |
| Overall Study | Study Terminated by Sponsor | 9 | 13 | 8 | 16 |
| Overall Study | Withdrawal of consent | 2 | 5 | 1 | 2 |
Baseline characteristics
| Characteristic | Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Total |
|---|---|---|---|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 9.28 | 69 years STANDARD_DEVIATION 8.44 | 69.3 years STANDARD_DEVIATION 7.51 | 71.3 years STANDARD_DEVIATION 8.12 | 69.6 years STANDARD_DEVIATION 8.35 |
| Region of Enrollment Belgium | 8 Participants | 9 Participants | 10 Participants | 14 Participants | 41 Participants |
| Region of Enrollment Germany | 7 Participants | 10 Participants | 5 Participants | 6 Participants | 28 Participants |
| Region of Enrollment Hungary | 6 Participants | 4 Participants | 6 Participants | 4 Participants | 20 Participants |
| Region of Enrollment Italy | 10 Participants | 9 Participants | 11 Participants | 19 Participants | 49 Participants |
| Region of Enrollment United Kingdom | 10 Participants | 9 Participants | 8 Participants | 8 Participants | 35 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 41 Participants | 41 Participants | 40 Participants | 42 Participants | 164 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 39 / 41 | 36 / 41 | 37 / 39 | 39 / 42 |
| serious Total, serious adverse events | 12 / 41 | 10 / 41 | 11 / 39 | 18 / 42 |
Outcome results
Primary
Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment
No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension.
Time frame: Week 24
Population: Safety population included all randomized and treated participants. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment | 70.6 Percentage of Participants |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment | 36.8 Percentage of Participants |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment | 60.0 Percentage of Participants |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment | 70.3 Percentage of Participants |
Secondary
Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale
BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (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 scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-SF; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed.
Time frame: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
Population: ITT population included all randomized participants regardless of whether they received any study treatment. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale | 1.31 Units on a scale | Standard Deviation 1.788 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale | 1.37 Units on a scale | Standard Deviation 1.952 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale | 1.80 Units on a scale | Standard Deviation 2.014 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale | 0.97 Units on a scale | Standard Deviation 1.61 |
Secondary
Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale
BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (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 scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Interference Index is the mean of the scores for the 7 items of the BPI-SF; range is 0=Does not interfere to 10=Completely interferes. LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed.
Time frame: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
Population: ITT population included all randomized participants regardless of whether they received any study treatment. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale | 0.89 Units on a scale | Standard Deviation 1.794 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale | 1.76 Units on a scale | Standard Deviation 2.1 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale | 1.52 Units on a scale | Standard Deviation 2.18 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale | 1.12 Units on a scale | Standard Deviation 1.687 |
Secondary
Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain
BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (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 scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Worst pain item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine. Last observation carried forward (LOCF) approach used for endpoint analysis. Last observation defined as last visit with non-missing data for parameter analyzed.
Time frame: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of main study treatment period [MSTP])
Population: ITT population included all randomized participants regardless of whether they received any study treatment. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain | 1.6 Units on a scale | Standard Deviation 2.43 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain | 2.2 Units on a scale | Standard Deviation 2.86 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain | 2.5 Units on a scale | Standard Deviation 2.39 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain | 1.3 Units on a scale | Standard Deviation 2.28 |
Secondary
Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS
EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed.
Time frame: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
Population: ITT population included all randomized participants regardless of whether they received any study treatment. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS | -4.5 Units on a scale | Standard Deviation 18.11 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS | -5.0 Units on a scale | Standard Deviation 16.82 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS | -6.6 Units on a scale | Standard Deviation 15.09 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS | -3.1 Units on a scale | Standard Deviation 13 |
Secondary
Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score
EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed.
Time frame: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
Population: ITT population included all randomized participants regardless of whether they received any study treatment. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score | -0.0694 Units on a scale | Standard Deviation 0.18402 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score | -0.0638 Units on a scale | Standard Deviation 0.17772 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score | -0.0728 Units on a scale | Standard Deviation 0.18113 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score | -0.0359 Units on a scale | Standard Deviation 0.13515 |
Secondary
Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score
FACT-P is a 39-item participant rated questionnaire which consists of 5 subscales assessing physical well-being (7 items; score range 0-28), social/family well-being (7 items; score range 0-28), emotional well-being (6 items; score range 0-24), functional well-being (7 items; score range 0-28), prostate-specific concerns (12 items; score range 0-48). Each item rated on 0 to 4 Likert type scale, then combined to produce subscale scores for each domain, as well as global quality of life (QoL) score that ranges from 0 to 156. Higher scores represent better QoL. Additional Concerns subscale has 12 items, each with a score 0-6 making a total subscale range 0-72 (higher scores are better). Missing data imputed as per FACT-P Ver4 scoring system (sum of item scores\*number of items in subscale/number of items answered).
Time frame: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
Population: ITT population included all randomized participants regardless of whether they received any study treatment. Here,'n'(number of participants analyzed) signifies the number of participants analyzed in specific category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Physical Well-Being | -0.98 Units on a scale | Standard Deviation 3.93 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Social/Family Well-Being | -0.01 Units on a scale | Standard Deviation 3.679 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Emotional Well-Being | -1.46 Units on a scale | Standard Deviation 4.785 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Functional Well-Being | -1.13 Units on a scale | Standard Deviation 4.575 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Global Score | -4.73 Units on a scale | Standard Deviation 18.248 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Additional Concerns | -1.29 Units on a scale | Standard Deviation 7.694 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Additional Concerns | -2.35 Units on a scale | Standard Deviation 6.342 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Functional Well-Being | -2.19 Units on a scale | Standard Deviation 5.767 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Physical Well-Being | -2.20 Units on a scale | Standard Deviation 4.449 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Emotional Well-Being | -0.89 Units on a scale | Standard Deviation 3.289 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Social/Family Well-Being | 0.61 Units on a scale | Standard Deviation 3.794 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Global Score | -6.62 Units on a scale | Standard Deviation 17.118 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Social/Family Well-Being | -0.78 Units on a scale | Standard Deviation 5.177 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Emotional Well-Being | -1.66 Units on a scale | Standard Deviation 3.915 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Functional Well-Being | -2.67 Units on a scale | Standard Deviation 5.957 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Additional Concerns | -3.96 Units on a scale | Standard Deviation 6.492 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Global Score | -10.39 Units on a scale | Standard Deviation 20.798 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Physical Well-Being | -2.46 Units on a scale | Standard Deviation 4.124 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Global Score | -5.77 Units on a scale | Standard Deviation 18.322 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Additional Concerns | -0.72 Units on a scale | Standard Deviation 6.08 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Social/Family Well-Being | -1.97 Units on a scale | Standard Deviation 5.749 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Functional Well-Being | -2.95 Units on a scale | Standard Deviation 6.698 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Physical Well-Being | -1.04 Units on a scale | Standard Deviation 3.268 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score | Emotional Well-Being | -0.02 Units on a scale | Standard Deviation 3.542 |
Secondary
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions , any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 millimetre \[mm\] short axis). PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 4.9 years
Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment. Population included participants with measurable disease at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Objective Response Rate (ORR) | 42.1 Percentage of participants |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Objective Response Rate (ORR) | 38.9 Percentage of participants |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Objective Response Rate (ORR) | 60.0 Percentage of participants |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Objective Response Rate (ORR) | 56.3 Percentage of participants |
Secondary
Overall Survival
Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.
Time frame: Up to 156 weeks
Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Overall Survival | 34.07 Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Overall Survival | 48.43 Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Overall Survival | 27.96 Months |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Overall Survival | 42.81 Months |
Secondary
Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12
The PSA response is defined as a \>= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2) criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show \>=50% decline from baseline.
Time frame: Week 12
Population: Intent-to-treat (ITT) population included all randomized participants regardless of whether they received any study treatment. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12 | 57.1 Percentage of Participants |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12 | 70.6 Percentage of Participants |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12 | 47.2 Percentage of Participants |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12 | 79.5 Percentage of Participants |
Secondary
Progression-Free Survival (PFS)
PFS: Time from randomization to one of following: radiographic progression (RP), clinical progression (CP) or death. RP- per PCWG2 criteria and modified RECIST as time from randomization to one of following: 1) considered to have progressed by bone scan if: a) first scan with \>=2 new lesions compared to baseline at \<12 weeks from randomization and confirmed by second scan \>=6 weeks later with \>=2 additional new lesions, b) first scan with \>=2 new lesions compared to baseline at \>=12 weeks from randomization and new lesions on next bone scan \>=6 weeks later; 2) Progression of soft tissue lesions per modified RECIST; CP: cancer pain requiring initiation of chronic use of opiate analgesia (oral use for \>=3 weeks; parenteral use for \>=7 days), Or immediate need to initiate cytotoxic chemotherapy or either radiation therapy or surgical intervention for complications due to tumor progression, even in absence of RP, Or deterioration in ECOG performance status to grade 3 or above.
Time frame: Up to 4.9 years
Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Progression-Free Survival (PFS) | 16.16 Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Progression-Free Survival (PFS) | 12.68 Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Progression-Free Survival (PFS) | 8.51 Months |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Progression-Free Survival (PFS) | 21.22 Months |
Secondary
Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point
Time to deterioration in ECOG Performance Status, the time interval from the date of randomization to the first date in which at least one point change (worsening) in the ECOG is observed during the main study treatment period. The ECOG performance status is a grade scale to measure quality of life (QoL). Scores run from 0 to 5, with 0 denoting perfect health and 5 denoting death.
Time frame: Up to 156 weeks
Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point | NA Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point | NA Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point | NA Months |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point | NA Months |
Secondary
Time to Next Prostate Cancer Therapy
Time to next prostate cancer therapy is defined as the time interval from the date of randomization to the date of initiation of first next therapy for prostate cancer.
Time frame: Up to 4.9 years
Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Time to Next Prostate Cancer Therapy | 20.14 Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Time to Next Prostate Cancer Therapy | 19.48 Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Time to Next Prostate Cancer Therapy | 16.66 Months |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Time to Next Prostate Cancer Therapy | 28.29 Months |
Secondary
Time to Opiate Use for Cancer-related Pain
Time to opiate use for cancer-related pain is defined the time interval from the date of randomization to the first date of opiate use for cancer pain.
Time frame: Up to 156 weeks
Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Time to Opiate Use for Cancer-related Pain | NA Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Time to Opiate Use for Cancer-related Pain | NA Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Time to Opiate Use for Cancer-related Pain | NA Months |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Time to Opiate Use for Cancer-related Pain | NA Months |
Secondary
Time to Prostate-Specific Antigen (PSA) Progression
Time to PSA progression was defined as time interval from the date of randomization to the date of the first prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group 2 (PSAWG2) criteria during the main study treatment period. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.
Time frame: Up to 156 weeks
Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | Time to Prostate-Specific Antigen (PSA) Progression | 10.38 Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | Time to Prostate-Specific Antigen (PSA) Progression | 10.22 Months |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | Time to Prostate-Specific Antigen (PSA) Progression | 4.83 Months |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | Time to Prostate-Specific Antigen (PSA) Progression | 18.56 Months |