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| ID | Type | Description | Link |
|---|---|---|---|
| 67652000PCR3002 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-002209-25 | EudraCT Number | ||
| 2023-506365-64-00 | Registry Identifier | EUCT number |
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The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).
Prostate cancer is a heterogenous disease and recent genomic analyses have highlighted specific germline and somatic mutations and alternative driver growth signaling pathways in patients with metastatic disease. Abiraterone acetate plus prednisone (AAP) is an established standard of care for the treatment of participants with mCSPC and is included in widely accepted clinical treatment guidelines. Niraparib in combination with AAP has been approved for the treatment of BRCA-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC). Niraparib is an investigational agent in the Metastatic Castration-Sensitive Prostate Cancer (mCSPC) population. Whether the addition of niraparib to the AAP standard of care may improve initial disease control and long-term outcomes compared with AAP alone in a biomarker selected mCSPC population is being evaluated on this trial. The study will consist of 4 phases; a Prescreening Phase for biomarker evaluation for eligibility only, a Screening Phase, a Treatment Phase, and a Follow-up Phase. Efficacy evaluations include the following: tumor measurements by computed tomography (CT), magnetic resonance imaging (MRI; abdomen, chest, and pelvis), Technetium-99m (99mTc) bone scans, serum prostate sensitive antigen (PSA) evaluations, and patient reported outcomes (PROs). Safety evaluations include incidence of adverse events and clinical laboratory parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niraparib with Abiraterone Acetate plus Prednisone (AAP) | Experimental | Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily. |
|
| AA plus Prednisone (AAP) | Active Comparator | Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Participants will receive Niraparib 200 mg once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator | rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors (RECIST) 1.1; (2) progression of bone lesions observed by bone scan per prostate cancer working group 3 (PCWG3) criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later. | From date of randomization (Day -3 to Day 1) up to approximately 49 months |
| HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator | rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan >= 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later. | From date of randomization (Day -3 to Day 1) up to approximately 49 months |
| All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator |
| Measure | Description | Time Frame |
|---|---|---|
| BRCA Subgroup: Time to Symptomatic Progression | Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers Of Alabama | Homewood | Alabama | 35209 | United States | ||
| Mayo Clinic Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41057655 | Derived | Attard G, Agarwal N, Graff JN, Sandhu S, Efstathiou E, Ozguroglu M, Pereira de Santana Gomes AJ, Vianna K, Luo H, Gotto GT, Cheng HH, Kim W, Varela CR, Schaeffer D, Kramer K, Li S, Baron B, Shen F, Mundle SD, McCarthy SA, Olmos D, Chi KN, Rathkopf DE. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nat Med. 2025 Dec;31(12):4109-4118. doi: 10.1038/s41591-025-03961-8. Epub 2025 Oct 7. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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The results presented are based on the primary completion date (07 January 2025). Remaining results will be reported within a year of study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo With Abiraterone Acetate Plus Prednisone | Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 28, 2023 | Jan 6, 2026 |
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| Abiraterone acetate (AA) | Drug | Participants will receive AA 1000 mg once daily. |
|
| Prednisone | Drug | Participants will receive prednisone 5 mg once daily. |
|
| Placebo for Niraparib | Drug | Participants will receive matching placebo for Niraparib once daily. |
|
rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan >= 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later.
| From date of randomization (Day -3 to Day 1) up to approximately 49 months |
| From date of randomization (Day -3 to Day 1) up to approximately 49 months |
| HRR Effector Subgroup: Time to Symptomatic Progression | Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms. | From date of randomization (Day -3 to Day 1) up to approximately 49 months |
| All HRR: Time to Symptomatic Progression | Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms. | From date of randomization (Day -3 to Day 1) up to approximately 49 months |
| Overall Survival (OS) | From date of randomization (Day -3 to Day 1) up to 83 months |
| Time to Subsequent Therapy | From date of randomization (Day -3 to Day 1) up to 83 months |
| Number of Participants With Treatment-emergent Serious Adverse Events | From Cycle 1 Day 1 up to 83 months |
| Number of Participants With Treatment-emergent Adverse Events by Severity | From Cycle 1 Day 1 up to 83 months |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Urological Associates of Southern Arizona, P.C. | Tucson | Arizona | 85741 | United States |
| Greater Los Angeles VA Healthcare System | Los Angeles | California | 90073 | United States |
| University of California Irvine Medical Center Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| San Bernardino Urological Associates | San Bernardino | California | 92404 | United States |
| University of San Francisco California | San Francisco | California | 94158 | United States |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80907 | United States |
| AdventHealth Medical Group Urology of Denver | Denver | Colorado | 80210 | United States |
| Colorado Clinical Research | Lakewood | Colorado | 80228 | United States |
| Eastern Connecticut Hematology & Oncology Assoc. | Norwich | Connecticut | 06360 | United States |
| Advanced Urology Institute | Daytona Beach | Florida | 32114 | United States |
| Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center | Fort Lauderdale | Florida | 33308 | United States |
| University of Florida Health Jacksonville | Jacksonville | Florida | 32209 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | United States |
| Urology of Indiana | Greenwood | Indiana | 46143 | United States |
| First Urology | Jeffersonville | Indiana | 47130 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Baltimore VA Medical Center | Baltimore | Maryland | 21201 | United States |
| Maryland Oncology Hematology, PA | Columbia | Maryland | 21044 | United States |
| Chesapeake Urology Associates | Towson | Maryland | 21204 | United States |
| Michigan Institute of Urology | Troy | Michigan | 48084 | United States |
| Mosaic Life Care | Saint Joseph | Missouri | 64507 | United States |
| St. Louis VA Medical Center | St Louis | Missouri | 63109 | United States |
| GU Research Network | Omaha | Nebraska | 68130 | United States |
| New York Oncology Hematology | Albany | New York | 12206 | United States |
| Manhattan VAMC | New York | New York | 10010 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Associated Medical Professionals | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Durham VAMC | Durham | North Carolina | 27705 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| VA Portland Health Care System | Portland | Oregon | 97239 | United States |
| Oregon Oncology Specialists | Salem | Oregon | 97301 | United States |
| Keystone Urology Specialists | Lancaster | Pennsylvania | 17604 | United States |
| Philadelphia VA Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15232 | United States |
| Ralph H. Johnson Veterans Affairs Medical Center | Charleston | South Carolina | 29401 | United States |
| Prisma Health | Seneca | South Carolina | 29672 | United States |
| Urology Associates | Nashville | Tennessee | 37209 | United States |
| Texas Oncology-Austin | Austin | Texas | 78731 | United States |
| Texas Oncology - Northeast | Denton | Texas | 76201 | United States |
| Houston Metro Urology | Houston | Texas | 77027 | United States |
| Texas Oncology P A | New Braunfels | Texas | 78130 | United States |
| Texas Oncology - Northeast 1 | Tyler | Texas | 75702 | United States |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Virginia Commonwealth University - Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| VA Puget Sound Healthcare System | Seattle | Washington | 98108 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| MultiCare Health System | Tacoma | Washington | 98405 | United States |
| CIPREC | Buenos Aires | C1061AAS | Argentina |
| Asociacion de Beneficencia Hospital Sirio Libanes | Buenos Aires | C1419AHN | Argentina |
| Centro Oncológico Korben | Buenos Aires | C1426AGE | Argentina |
| Hospital Militar Cosme Argerich | C.a.b.a. | C1426BOR | Argentina |
| CINME Centro de Investigaciones Metabolicas | Caba | C1056ABI | Argentina |
| Centro de Urologia (CDU) | Ciudad Automoma Buenos Aires | C1120AAT | Argentina |
| Hospital Italiano de Buenos Aires | Ciudad Autonoma de | C1199ABB | Argentina |
| Clinica Adventista Belgrano | Ciudad de Buenos Aires | C1430EGF | Argentina |
| Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Córdoba | 5000 | Argentina |
| Centro Urologico Profesor Bengio | Córdoba | X5000KPH | Argentina |
| Instituto Médico de RÃo Cuarto | Córdoba | X5800 | Argentina |
| Hospital Privado de Cordoba | Córdoba | XX5016KEH | Argentina |
| Hospital Privado de Comunidad | Mar del Plata | B7602CBM | Argentina |
| Centro de Investigacion Pergamino SA | Pergamino | B2700CPM | Argentina |
| ARS Médica | San Salvador de Jujuy | Y4600AFW | Argentina |
| Sunshine Coast University Hospital | Birtinya | 4575 | Australia |
| St Vincent s Hospital Sydney | Darlinghurst | 2010 | Australia |
| Cancer Care Services Clinical Research Unit | Herston | 4029 | Australia |
| Royal Hobart Hospital | Hobart | 7000 | Australia |
| Icon Cancer Centre Kurralta Park | Kurralta Park | 5037 | Australia |
| Liverpool Hospital | Liverpool | 2170 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | 3000 | Australia |
| Fiona Stanley Hospital | Murdoch | 6150 | Australia |
| Macquarie University Hospital | North Ryde | 2109 | Australia |
| ICON Cancer Care | South Brisbane | 4101 | Australia |
| St John of God Subiaco Hospital | Subiaco | 6008 | Australia |
| Bobruisk Interregional Oncology Dispensary | Babruysk | 213825 | Belarus |
| Brest Regional Oncology Dispensary | Brest | 224027 | Belarus |
| Grodno University Hospital | Grodno | 230017 | Belarus |
| Gomel Regional Clinical Oncology Dispensary | Homyel | 246012 | Belarus |
| N N Alexandrov National Cancer Centre of Belarus | Lesnoy | 223040 | Belarus |
| Minsk city Clinical Oncological Dispensary | Minsk | 220013 | Belarus |
| Mogilev Regional Oncology Dispensary | Mogilev | 212018 | Belarus |
| Vitebsk Regional Clinical Oncology Dispensary | Vitebsk | 210603 | Belarus |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| ZAS Augustinus | Antwerp | 2610 | Belgium |
| Grand Hopital De Charleroi Site Les Viviers | Charleroi | 6060 | Belgium |
| Jolimont | Haine-St-Paul | 7100 | Belgium |
| CHC MontLegia | Liège | 4000 | Belgium |
| CHU UCL Namur - Site Sainte Elisabeth | Namur | 5000 | Belgium |
| Clinique St Pierre | Ottignies | 1340 | Belgium |
| Algemeen Ziekenhuis Delta | Roeselare | 8800 | Belgium |
| Fundacao Pio XII | Barretos | 14784-400 | Brazil |
| Cetus Oncologia | Belo Horizonte | 30110-022 | Brazil |
| PERSONAL Oncologia de Precisao e Personalizada | Belo Horizonte | 30130-090 | Brazil |
| CIONC Centro Integrado de Oncologia de Curitiba | Curitiba | 80810 050 | Brazil |
| Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN | Florianópolis | 88034-000 | Brazil |
| Pronutrir | Fortaleza | 60 810180 | Brazil |
| Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge | Goiânia | 74605-070 | Brazil |
| Fundacao Sao Francisco Xavier | Ipatinga | 35162 189 | Brazil |
| Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia | Joinville | 89201-260 | Brazil |
| Liga Norte Riograndense Contra O Cancer | Natal | 59075-740 | Brazil |
| UPCO Unidade de Pesquisa Clinica em Oncologia | Pelotas | 96020 080 | Brazil |
| Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre | 90020-090 | Brazil |
| Hospital Ernesto Dornelles | Porto Alegre | 90160-093 | Brazil |
| MultiHemo Servicos Medicos S.A | Recife | CEP: 50070-460 | Brazil |
| Ministerio da Saude Instituto Nacional do Cancer | Rio de Janeiro | 20230-130 | Brazil |
| Universidade do Estado do Rio de Janeiro - UERJ | Rio de Janeiro | 20551-030 | Brazil |
| Oncoclinicas Rio de Janeiro S A | Rio de Janeiro | 22250 905 | Brazil |
| Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) | Rio de Janeiro | 22775 001 | Brazil |
| Nucleo de Oncologia da Bahia | Salvador | 40170 110 | Brazil |
| Hospital Sao Rafael | Salvador | 41253 190 | Brazil |
| Fundacao do ABC Centro Universitario FMABC | Santo André | 09060 870 | Brazil |
| Instituto do Cancer Arnaldo Vieira de Carvalho | São Paulo | 01221 020 | Brazil |
| Irmandade Santa Casa de Misericordia de Sao Paulo | São Paulo | 01221-020 | Brazil |
| Instituto de Ensino e Pesquisa São Lucas | São Paulo | 01236-030 | Brazil |
| Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo | São Paulo | 01246 000 | Brazil |
| Real e Benemerita Associacao Portuguesa de Beneficencia | São Paulo | 01323 900 | Brazil |
| Hospital Alemao Oswaldo Cruz | São Paulo | 01421-000 | Brazil |
| Núcleo de Pesquisa São Camilo | São Paulo | 04014-002 | Brazil |
| Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE | São Paulo | 04039-004 | Brazil |
| IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado | Sorocaba | 18030-005 | Brazil |
| Centro Oncológico do Triângulo | Uberlândia | 38408-150 | Brazil |
| MHAT Deva Maria | Burgas | 8001 | Bulgaria |
| UMHAT Dr Georgi Stranski EAD 1 | Pleven | 5800 | Bulgaria |
| Complex Oncology Center - Plovdiv EOOD | Plovdiv | 4004 | Bulgaria |
| Multifunctional Hospital for Active Treatment for Women Health Nadezhda | Sofia | 1330 | Bulgaria |
| Specialized Hospital for Active Treatment in Oncology | Sofia | 1756 | Bulgaria |
| UMHAT Sofia Med | Sofia | 1797 | Bulgaria |
| Comprehensive Cancer Center | Vratsa | 3001 | Bulgaria |
| Prostate Cancer Centre | Calgary | Alberta | T2V 1P9 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI) | Kelowna | British Columbia | V1Y 5L3 | Canada |
| British Columbia Cancer Agency BCCA Vancouver Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| British Columbia Cancer Agency Vancouver Island Centre | Victoria | British Columbia | V8R 6V5 | Canada |
| McMaster Institute of Urology | Hamilton | Ontario | L8N 4A6 | Canada |
| Kingston Health Sciences Centre, Kingston General Health Research Institute | Kingston | Ontario | K7L2V7 | Canada |
| Sunnybrook Health Sciences Center | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre University Health Network | Toronto | Ontario | M5G2M9 | Canada |
| Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2X 0A9 | Canada |
| McGill University - Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | 100021 | China |
| Peking University First Hospital | Beijing | 100034 | China |
| Beijing Friendship Hospital Capital Medical University | Beijing | 100050 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| Beijing University Third Hospital | Beijing | 100191 | China |
| Beijing Hospital | Beijing | 100730 | China |
| West China Hospital of Sichuan University | Chengdu | 610041 | China |
| Sichuan Provincial Peoples Hospital | Chengdu | 610072 | China |
| Western Theater General Hospital of the Chinese People's Liberation Army | Chengdu | 610083 | China |
| Chongqing University Cancer Hospital | Chongqing | 400030 | China |
| Southwest Hospital, The Third Military Medical University | Chongqing | 400038 | China |
| Sun Yat Sen University Cancer Center | Guangzhou | 430030 | China |
| Guangzhou First Municipal People's Hospital | Guangzhou | 510180 | China |
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou | 510289 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | 310014 | China |
| The First Affiliated Hospital of NanChang University | Nanchang | 330006 | China |
| Jiangsu Province Cancer Hospital | Nanjing | 210000 | China |
| Nanjing Drum Tower Hospital | Nanjing | 210008 | China |
| The First Affiliated Hospital of Ningbo University | Ningbo | 315010 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Huashan Hospital Fudan University | Shanghai | 200040 | China |
| Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University | Shanghai | 200127 | China |
| The Fifth People's Hospital of Shanghai, Fudan University | Shanghai | 200240 | China |
| Huadong Hospital Affiliated to Fudan University | Shanghai | 200400 | China |
| Shengjing Hospital Of China Medical University | Shenyang | 110004 | China |
| Second Affiliated Hospital of Soochow University | Suzhou | 200233 | China |
| The First Affliated Hospital of Soochow University | Suzhou | 215006 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | 325000 | China |
| TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology | Wuhan | 430030 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | 710061 | China |
| Fakultni nemocnice u sv. Anny v Brne | Brno | 656 91 | Czechia |
| FN Hradec Kralove, Urologicka klinika | Hradec Králové | 500 05 | Czechia |
| Krajská nemocnice Liberec | Liberec | 460 63 | Czechia |
| Uromedical Center s.r.o. | Olomouc | 77900 | Czechia |
| Urologicka klinika 1 LF UK a VFN | Prague | 128 00 | Czechia |
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
| Copenhagen University Hospital | Copenhagen | 2100 | Denmark |
| Herlev Hospital | Herlev | DK-2730 | Denmark |
| Næstved Hospital | Næstved | 4700 | Denmark |
| Odense Universitetshospital | Odense | DK-5000 | Denmark |
| Vejle Hospital | Vejle | DK-7100 | Denmark |
| Institut de Cancerologie de l Ouest ICO | Angers | 49933 | France |
| Institut Sainte Catherine | Avignon | 84918 | France |
| CHRU De Besancon | Besançon | 25030 | France |
| Institut Bergonie | Bordeaux | 33000 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre Georges Francois Leclerc | Dijon | 21000 | France |
| Centre Oscar Lambret | Lille | 59000 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| Hopital Prive Jean Mermoz | Lyon | 69008 | France |
| Institut Regional du Cancer de Montpellier Val d'Aurelle | Montpellier | 34298 | France |
| Polyclinique de Gentilly | Nancy | 54100 | France |
| CHU De Poitiers | Poitiers | 86021 | France |
| Centre Hopitalier Inter-Communal De Cornouaille | Quimper | 29000 | France |
| HIA Begin | Saint-Mandé | 94163 | France |
| Institut de Cancérologie de Loire | Saint-Priest-en-Jarez | 42271 | France |
| Clinique Sainte Anne | Strasbourg | 67000 | France |
| Hopital Foch | Suresnes | 32151 | France |
| CHRU de Tours | Tours | 37044 | France |
| Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer | Braunschweig | 38126 | Germany |
| Universitaetsklinikum Koelnt | Cologne | 50937 | Germany |
| Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I | Dresden | 01307 | Germany |
| Urologicum Duisburg | Duisburg | 47169 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Klinikum rechts der Isar - III. Med. Klinik und Poliklinik | München | 81675 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Studienpraxis Urologie Drs. Feyerabend | Nürtingen | 72622 | Germany |
| Jahn Ferenc Del-pesti Korhaz es Rendelointezet | Budapest | 1204 | Hungary |
| Debreceni Egyetem | Debrecen | 4032 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | 9024 | Hungary |
| Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Gyula | 5700 | Hungary |
| Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz | Miskolc | 3526 | Hungary |
| Szegedi Tudomanyegyetem | Szeged | 6720 | Hungary |
| Szent Borbala Hospital Tatabanya | Tatabánya | 2800 | Hungary |
| Haemek Medical Center - Afula | Afula | 1834111 | Israel |
| Soroka Hospital | Beersheba | 85101 | Israel |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Hadassah Hospital | Jerusalem | 91200 | Israel |
| Rabin Medical Center, Beilinson Hospital | Petach Tikvah | 49100 | Israel |
| Sheba Medical Center Tel Hashomer | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Ospedale S. Donato - Asl 8 Arezzo | Arezzo | 52100 | Italy |
| Divisione di Oncologia - Istituto per la ricerca e cura del cancro | Candiolo | 10060 | Italy |
| Istituti Ospitalieri di Cremona, AO di Cremona | Cremona | 26100 | Italy |
| Azienda Ospedaliera ''Vito Fazzi'' | Lecce | 73100 | Italy |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | 47014 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| European Institute of Oncology | Milan | 20141 | Italy |
| Fondazione G Pascale Istituto Nazionale Tumori IRCCS | Naples | 80138 | Italy |
| Aou San Luigi Gonzaga | Orbassano | 10043 | Italy |
| Istituto Oncologico Veneto Iov Irccs Padova | Padova | 35128 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| ASL Napoli 2 Nord-SM delle Grazie Hospital | Pozzuoli | 80078 | Italy |
| Casa Sollievo Della Sofferenza IRCCS | San Giovanni Rotondo | 71013 | Italy |
| Ospedale S. Chiara | Trento | Italy |
| Ospedale San Bortolo | Vicenza | 36100 | Italy |
| Hospital Pulau Pinang | George Town | 10990 | Malaysia |
| Hospital Sultan Ismail | Johor Bahru | 81100 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Sarawak General Hospital | Kuching | 93586 | Malaysia |
| Institut Kanser Negara Clinical Research Center | Putrajaya | 62250 | Malaysia |
| Consultorio de Especialidad en Urologia Privado | Durango | 34000 | Mexico |
| Consultorio Privado | León | 37000 | Mexico |
| Centro de Investigacion ClÃnica Gramel S.C.1 | Mexico City | 3720 | Mexico |
| Avix Investigacion Clinica S C | Monterrey | 64710 | Mexico |
| i Can Oncology Center | Monterrey | 64710 | Mexico |
| Oncologia Integral Satelite | Naucalpan | 53100 | Mexico |
| Centro de Investigacion Clinica de Oaxaca | Oaxaca City | 68020 | Mexico |
| Consultorio Privado 1 | Zapopan | 45040 | Mexico |
| Reinier de Graaf Gasthuis | Delft | 2625 AD | Netherlands |
| Tergooiziekenhuizen | Hilversum | 1213XZ | Netherlands |
| Canisius-Wilhelminaziekenhuis | Nijmegen | 6532 SZ | Netherlands |
| Elisabeth-TweeSteden Ziekenhuis | Tilburg | 5022 GC | Netherlands |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Canterbury Urology Research Trust | Christchurch | 8013 | New Zealand |
| Dunedin Hospital | Dunedin Central | 9016 | New Zealand |
| Tauranga Hospital | Tauranga | 3112 | New Zealand |
| IN VIVO Sp. z o.o | Bydgoszcz | 85 048 | Poland |
| Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza | Bydgoszcz | 85 094 | Poland |
| Centrum Onkologii im Prof F Lukaszczyka | Bydgoszcz | 85 796 | Poland |
| Szpitale Pomorskie Sp z o o | Gdynia | 81 519 | Poland |
| Przychodnia Lekarska KOMED Roman Karaszewski | Konin | 62-500 | Poland |
| Klinika MedTrials | Krakow | 30 539 | Poland |
| Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi | Lodz | 93-509 | Poland |
| Medisport | Lublin | 20-223 | Poland |
| Urologica Praktyka Lekarska Adam Marcheluk | Siedlce | 08-110 | Poland |
| Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O | Warsaw | 04 073 | Poland |
| Specjalistyczna przychodnia lekarska POLIMED | Wroclaw | 53-329 | Poland |
| Uls Almada Seixal - Hosp. Garcia de Orta | Almada | 2805-607 | Portugal |
| Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A. | Coimbra | 3000075 | Portugal |
| Fund. Champalimaud | Lisbon | 1400-038 | Portugal |
| Uls Santa Maria - Hosp. Santa Maria | Lisbon | 1649 035 | Portugal |
| Puerto Rico Medical Research Center | Hato Rey | 00917 | Puerto Rico |
| Altai Regional Oncology Dispensary | Barnaul | 656045 | Russia |
| Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine | Chelyabinsk | 454087 | Russia |
| Ivanovo Regional Oncology Dispensary | Ivanovo | 153040 | Russia |
| Moscow City Clinical Hospital # 62 | Moscow | 125130 | Russia |
| Hertzen Oncology Research Institute | Moscow | 125284 | Russia |
| Privolzhsky District Medical Centre | Nizhny Novgorod | 603001 | Russia |
| Clinical Oncology Dispensary | Omsk | 644013 | Russia |
| LLC Novaya Clinica | Pyatigorsk | 357500 | Russia |
| Pyatigorsk Interdistrict Oncology Dispensary | Pyatigorsk | 357502 | Russia |
| Leningrad Regional Oncology Dispensary | Saint Petersburg | 191104 | Russia |
| Private Medical Institution Euromedservice | Saint Petersburg | 196603 | Russia |
| Republican Oncology Dispensary | Saransk | 430032 | Russia |
| Tomsk Cancer Research Institute | Tomsk | 634050 | Russia |
| Multifunctional clinical medical center 'Medical city' | Tyumen | 625041 | Russia |
| Bashkir State Medical University | Ufa | 450083 | Russia |
| CancerCare Rondebosch | Cape Town | 7700 | South Africa |
| Steve Biko Academic Hospital | Pretoria | 0001 | South Africa |
| East Rand Urology Research Unit | Vosloorus | 1475 | South Africa |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 42601 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| National Cancer Center | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital, Yonsei University Health System | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Mary s Hospital | Seoul | 06591 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Hosp Univ A Coruna | A Coruña | 15006 | Spain |
| Hosp. de La Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Gral. Univ. de Castellon | Castellon | 12004 | Spain |
| Institut Català D'Oncologia Girona | Girona | 17007 | Spain |
| Hosp. de Jerez de La Frontera | Jerez de la Frontera | 11407 | Spain |
| Hosp. Univ. de La Princesa | Madrid | 28006 | Spain |
| Hosp. Univ. Ramon Y Cajal | Madrid | 28034 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Hosp. Univ. Hm Monteprincipe | Madrid | 28660 | Spain |
| Hosp Virgen de La Victoria | Málaga | 29010 | Spain |
| Corporacio Sanitari Parc Tauli | Sabadell | 08208 | Spain |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| Hosp. Virgen Del Rocio | Seville | 41013 | Spain |
| Hosp. Clinico Univ. de Valencia | Valencia | 46010 | Spain |
| Salgrenska University hospital | Gothenburg | 413 45 | Sweden |
| Urologiska Mottagningen | Malmö | 205 02 | Sweden |
| Sodersjukhuset | Stockholm | 11883 | Sweden |
| Karolinska Universitetssjukhuset Solna | Stockholm | 17164 | Sweden |
| Kaohsiung Medical University Chung Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| Tungs' Taichung MetroHarbor Hospital | Taichung | 435 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang-Gung Memorial Hospital, LinKou Branch | Taoyuan | 333 | Taiwan |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Adana Baskent Yuregir Hospital | Adana | 01250 | Turkey (Türkiye) |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi | Ankara | 06200 | Turkey (Türkiye) |
| Memorial Ankara Hastanesi | Ankara | 06520 | Turkey (Türkiye) |
| Gazi Hastanesi | Ankara | 06560 | Turkey (Türkiye) |
| Ankara University Medical Faculty | Ankara | 06590 | Turkey (Türkiye) |
| Ankara Bilkent Sehir Hastanesi | Ankara | 06800 | Turkey (Türkiye) |
| Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi | Bursa | 16310 | Turkey (Türkiye) |
| Trakya University Medical Faculty | Edirne | 22030 | Turkey (Türkiye) |
| Istanbul University Istanbul Medical Faculty | Istanbul | 34000 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd | Istanbul | 34098 | Turkey (Türkiye) |
| Bakirkoy Training and Research Hospital | Istanbul | 34147 | Turkey (Türkiye) |
| T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi | Istanbul | 34722 | Turkey (Türkiye) |
| Dokuz Eylul Universitesi Arastirma ve Uygulama Hastanesi | Izmir | 35340 | Turkey (Türkiye) |
| Izmir Medical Point Hospital | Izmir | 35530 | Turkey (Türkiye) |
| Sakarya Üniversitesi Tıp Fakültesi Hastanesi | Sakarya | 54050 | Turkey (Türkiye) |
| Medical Park Samsun Hastanesi | Samsun | 55200 | Turkey (Türkiye) |
| CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC | Cherkasy | 18009 | Ukraine |
| Municipal Non-profit enterprise 'Bukovinian clinical oncology center' | Chernivtsi | 58013 | Ukraine |
| Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc | Dnipro | 49005 | Ukraine |
| Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council | Dnipro | 49100 | Ukraine |
| Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4 | Dnipro | 49102 | Ukraine |
| Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | 76008 | Ukraine |
| Communal Institution 'City hospital â„–7 of Kamianske' of Dnepropetrov'sk Regional Council | Kamyanske | 51900 | Ukraine |
| Municipal non-profit enterprise 'Regional Center of Oncology' | Khakhiv | 61070 | Ukraine |
| Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval | Kharkiv | 61037 | Ukraine |
| Kherson Regional Oncological Dispensary | Kherson | 73035 | Ukraine |
| State Nonprofit Enterprise National Cancer Institute | Kyiv | 03022 | Ukraine |
| State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center | Kyiv | 03115 | Ukraine |
| Kyiv Regional Oncological Dispensary | Kyiv | 04107 | Ukraine |
| Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' | Lviv | 79010 | Ukraine |
| Podilskiy Regional Center of Oncology | Vinnitsa | 21029 | Ukraine |
| Municipal non-profit enterprise Zhytomyr Regional Oncology Dispensary of Zhytomyr Regional Council | Zhytomyr | 10002 | Ukraine |
| Ysbyty Gwynedd | Bangor | LL57 2PW | United Kingdom |
| Belfast City Hospital | Belfast | BT9 7AB | United Kingdom |
| Brighton and Sussex University Hospitals NHS Trust | Brighton | BN2 5BE | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | BS2 8ED | United Kingdom |
| Guy's Hospital | Great Maze Pond | SE1 9RT | United Kingdom |
| Prince Of Wales Hospital | Grimsby | DN33 2BA | United Kingdom |
| Marie Curie Research Wing - Mount Vernon Hospital | Hillingdon | HA6 2RN | United Kingdom |
| Raigmore Hospital | Inverness | IV2 3UJ | United Kingdom |
| University College London Hospitals NHSFT | London | NW1 2PG | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LE | United Kingdom |
| Royal Preston Hospital | Preston | PR2 9HT | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital | Truro | TR1 3LJ | United Kingdom |
| FG001 | Niraparib With Abiraterone Acetate Plus Prednisone | Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2* [100 mg niraparib/500 mg AA tablet]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days. |
| Treated |
|
| BRCA Subgroup |
|
| HRR Effector Subgroup |
|
| All HRR |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo With Abiraterone Acetate Plus Prednisone | Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days. |
| BG001 | Niraparib With Abiraterone Acetate Plus Prednisone | Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2* [100 mg niraparib/500 mg AA tablet]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator | rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors (RECIST) 1.1; (2) progression of bone lesions observed by bone scan per prostate cancer working group 3 (PCWG3) criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later. | BRCA full analysis set (FAS) included all randomized participants with BRCA gene alteration classified according to their assigned treatment arm, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | months | From date of randomization (Day -3 to Day 1) up to approximately 49 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator | rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan >= 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later. | HRR effector FAS included all randomized HRR effector participants classified according to their assigned treatment arm, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | months | From date of randomization (Day -3 to Day 1) up to approximately 49 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator | rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan >= 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later. | All HRR FAS included all randomized participants classified according to their assigned treatment arm, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | months | From date of randomization (Day -3 to Day 1) up to approximately 49 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | BRCA Subgroup: Time to Symptomatic Progression | Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms. | BRCA FAS included all randomized participants with BRCA gene alteration classified according to their assigned treatment arm, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | months | From date of randomization (Day -3 to Day 1) up to approximately 49 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HRR Effector Subgroup: Time to Symptomatic Progression | Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms. | HRR effector FAS included all randomized HRR effector participants classified according to their assigned treatment arm, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | months | From date of randomization (Day -3 to Day 1) up to approximately 49 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All HRR: Time to Symptomatic Progression | Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms. | All HRR FAS included all randomized participants classified according to their assigned treatment arm, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | months | From date of randomization (Day -3 to Day 1) up to approximately 49 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Not Posted | Nov 2028 | From date of randomization (Day -3 to Day 1) up to 83 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Subsequent Therapy | Not Posted | Nov 2028 | From date of randomization (Day -3 to Day 1) up to 83 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Serious Adverse Events | Not Posted | Nov 2028 | From Cycle 1 Day 1 up to 83 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events by Severity | Not Posted | Nov 2028 | From Cycle 1 Day 1 up to 83 months | Participants |
All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
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 | Placebo With Abiraterone Acetate Plus Prednisone | Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days. | 108 | 348 | 96 | 348 | 326 | 348 |
| EG001 | Niraparib With Abiraterone Acetate Plus Prednisone | Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2* [100 mg niraparib/500 mg AA tablet]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days. | 85 | 348 | 136 | 347 | 338 | 347 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Coronary Artery Stenosis | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Right Ventricular Failure | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Gastric Haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Gastric Stenosis | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Gastrointestinal Angiodysplasia | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Impaired Gastric Emptying | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Intestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Peptic Ulcer | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Varices Oesophageal | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Biliary Obstruction | Hepatobiliary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Allergy to Arthropod Sting | Immune system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Alpha Haemolytic Streptococcal Infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Clostridium Difficile Infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dengue Fever | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Gastroenteritis Salmonella | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Metapneumovirus Pneumonia | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Necrotising Fasciitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pneumonia Influenzal | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pneumonia Mycoplasmal | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pneumonia Respiratory Syncytial Viral | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Psoas Abscess | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pulmonary Sepsis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Bladder Injury | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hand Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Multiple Fractures | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Procedural Complication | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urinary Tract Stoma Complication | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urostomy Complication | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Diabetic Ketosis | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Joint Range of Motion Decreased | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Adenocarcinoma Gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Gastrointestinal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Malignant Melanoma Stage Iii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Metastatic Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Neuroendocrine Tumour of the Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Ocular Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Papillary Cystadenoma Lymphomatosum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Basal Ganglia Infarction | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cerebral Artery Occlusion | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cerebral Ischaemia | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cerebral Venous Sinus Thrombosis | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Haemorrhagic Stroke | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypoglycaemic Encephalopathy | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Nervous System Disorder | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Bladder Outlet Obstruction | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Bladder Tamponade | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Calculus Bladder | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Calculus Urinary | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Lower Urinary Tract Symptoms | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urethral Stenosis | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Aortic Stenosis | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Essential Hypertension | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
|
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 | |
|---|---|---|---|---|
| Executive Director Clinical Prostate | Janssen Research and Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2025 | Jan 6, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| C545685 | niraparib |
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| From 65 to 84 years |
|
| 85 years and over |
|
| AUSTRALIA |
|
| BELARUS |
|
| BELGIUM |
|
| BRAZIL |
|
| BULGARIA |
|
| CANADA |
|
| CHINA |
|
| CZECH REPUBLIC |
|
| DENMARK |
|
| FRANCE |
|
| GERMANY |
|
| HUNGARY |
|
| ISRAEL |
|
| ITALY |
|
| MALAYSIA |
|
| MEXICO |
|
| NETHERLANDS |
|
| NEW ZEALAND |
|
| POLAND |
|
| PORTUGAL |
|
| RUSSIAN FEDERATION |
|
| SOUTH AFRICA |
|
| SOUTH KOREA |
|
| SPAIN |
|
| SWEDEN |
|
| TAIWAN |
|
| THAILAND |
|
| TURKEY |
|
| UKRAINE |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
| OG001 | HRR Effector Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone | Participants with deleterious germline or somatic HRR gene-mutated mCSPC and HRR effector gene alterations were randomized to receive niraparib and AA FDC tablets (2* [100 mg niraparib/500 mg AA tablet]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days. |
|
|
|
| OG001 | Niraparib With Abiraterone Acetate Plus Prednisone | Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2* [100 mg niraparib/500 mg AA tablet]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days. |
|
|
|
Participants with deleterious germline or somatic HRR gene-mutated mCSPC and BRCA alterations were randomized to receive niraparib and AA FDC tablets (2* [100 mg niraparib/500 mg AA tablet]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days. |
|
|
|
Participants with deleterious germline or somatic HRR gene-mutated mCSPC and HRR effector gene alterations were randomized to receive niraparib and AA FDC tablets (2* [100 mg niraparib/500 mg AA tablet]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days. |
|
|
|
Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2* [100 mg niraparib/500 mg AA tablet]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days. |
|
|
|