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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004331-23 | EudraCT Number | ||
| 212082PCR2023 | Other Identifier | Janssen CTMS ID |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AA + prednisone 5 mg twice daily | Experimental | Abiraterone acetate in combination with prednisone 5 mg twice daily |
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| AA + prednisone 5 mg once daily | Experimental | Abiraterone acetate in combination with prednisone 5 mg once daily dose |
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| AA + prednisone 2.5 mg twice daily | Experimental | Abiraterone acetate in combination with prednisone 2.5 mg twice daily |
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| AA + dexamethasone 0.5 mg once daily | Experimental | Abiraterone acetate in combination with dexamethasone 0.5 mg once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone Acetate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalst | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33794293 | Derived | Jayaram A, Wingate A, Wetterskog D, Wheeler G, Sternberg CN, Jones R, Berruti A, Lefresne F, Lahaye M, Thomas S, Gormley M, Meacham F, Garg K, Lim LP, Merseburger AS, Tombal B, Ricci D, Attard G. Plasma tumor gene conversions after one cycle abiraterone acetate for metastatic castration-resistant prostate cancer: a biomarker analysis of a multicenter international trial. Ann Oncol. 2021 Jun;32(6):726-735. doi: 10.1016/j.annonc.2021.03.196. Epub 2021 Mar 29. | |
| 32923850 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Prednisone 5 mg twice daily | Drug | 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 |
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| Prednisone 5 mg once daily | Drug | type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken once daily, in the morning after a meal |
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| Prednisone 2.5 mg twice daily | Drug | 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 |
|
| Dexamethasone 0.5 mg once daily | Drug | type = exact number; unit = mg; number = 0.5; form = tablet; route = oral; taken once daily, in the morning after breakfast |
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| Week 12 |
| 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. | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of main study treatment period [MSTP]) |
| 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. | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) |
| 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. | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) |
| 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. | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) |
| 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. | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) |
| 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). | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) |
| 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. | Up to 4.9 years |
| 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. | Up to 156 weeks |
| 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. | Up to 4.9 years |
| 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. | Up to 156 weeks |
| 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. | Up to 156 weeks |
| Overall Survival | Overall survival was defined as the time interval from the date of randomization to the date of death from any cause. | Up to 156 weeks |
| 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. | Up to 4.9 years |
| Brussels |
| Belgium |
| Ghent | Belgium |
| Hasselt | Belgium |
| Kortrijk | Belgium |
| Leuven | Belgium |
| Hanover | Germany |
| Mülheim | Germany |
| Nürtingen | Germany |
| Tübingen | Germany |
| Budapest | Hungary |
| Miskolc | Hungary |
| Birmingham | United Kingdom |
| Glasgow | United Kingdom |
| London | United Kingdom |
| Sutton | United Kingdom |
| Whitchurch | United Kingdom |
| Derived |
| Jayaram A, Wingate A, Wetterskog D, Conteduca V, Khalaf D, Sharabiani MTA, Calabro F, Barwell L, Feyerabend S, Grande E, Martinez-Carrasco A, Font A, Berruti A, Sternberg CN, Jones R, Lefresne F, Lahaye M, Thomas S, Joshi S, Shen D, Ricci D, Gormley M, Merseburger AS, Tombal B, Annala M, Chi KN, De Giorgi U, Gonzalez-Billalabeitia E, Wyatt AW, Attard G. Plasma Androgen Receptor Copy Number Status at Emergence of Metastatic Castration-Resistant Prostate Cancer: A Pooled Multicohort Analysis. JCO Precis Oncol. 2019 Sep 24;3:PO.19.00123. doi: 10.1200/PO.19.00123. eCollection 2019. |
| 31246234 | Derived | Attard G, Merseburger AS, Arlt W, Sternberg CN, Feyerabend S, Berruti A, Joniau S, Geczi L, Lefresne F, Lahaye M, Shelby FN, Pissart G, Chua S, Jones RJ, Tombal B. Assessment of the Safety of Glucocorticoid Regimens in Combination With Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer: A Randomized, Open-label Phase 2 Study. JAMA Oncol. 2019 Aug 1;5(8):1159-1167. doi: 10.1001/jamaoncol.2019.1011. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
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| COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| 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. | Safety population included all randomized and treated participants. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 24 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of main study treatment period [MSTP]) |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) |
| ||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP) |
| ||||||||||||||||||||||||||||||||||||
| 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. | Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 4.9 years |
| ||||||||||||||||||||||||||||||||||||
| 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. | Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 156 weeks |
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| 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. | 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. | Posted | Number | Percentage of participants | Up to 4.9 years |
| |||||||||||||||||||||||||||||||||||||
| 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. | Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 156 weeks |
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| 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. | Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 156 weeks |
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| Secondary | Overall Survival | Overall survival was defined as the time interval from the date of randomization to the date of death from any cause. | Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 156 weeks |
| ||||||||||||||||||||||||||||||||||||
| 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. | Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 4.9 years |
|
Up to 4.9 years
Safety population included all randomized and treated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 12 | 41 | 39 | 41 | ||
| EG001 | 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. | 10 | 41 | 36 | 41 | ||
| EG002 | 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. | 11 | 39 | 37 | 39 | ||
| EG003 | 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. | 18 | 42 | 39 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia of Malignant Disease | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Ventricular Arrhythmia | Cardiac disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Device Occlusion | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Neuroendocrine Carcinoma of the Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Nerve Root Compression | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Bladder Tamponade | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Anaemia of Malignant Disease | Blood and lymphatic system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Ventricular Arrhythmia | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Incarcerated Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Obstructive Pancreatitis | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pancreatic Cyst | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Performance Status Decreased | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Ketosis | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Mobility Decreased | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Neuroendocrine Carcinoma of the Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dementia Alzheimer's Type | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Frontotemporal Dementia | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Haemorrhage Intracranial | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Nerve Root Compression | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Device Occlusion | Product Issues | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Bladder Tamponade | Renal and urinary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Renal Colic | Renal and urinary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Circulatory Collapse | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Skin Atrophy | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
|
Study not designed/powered to allow comparisons in study groups. Per protocol amendment 6, the study was ended earlier since sufficient extension and follow-up data have been collected to allow statistical analysis of secondary objectives.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Janssen Pharmaceutica N.V | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Germany |
|
| United Kingdom |
|
| Hungary |
|
| Italy |
|
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.
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
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.
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
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