Исследование нирапариба в комбинации с абиратеронацетатом и преднизоном по сравнению с абиратеронацетатом и преднизоном для лечения пациентов с разрушительной зародышевой линией или соматической гомологичной рекомбинацией (HRR), генетически мутировавшим, метастатическим, чувствительным к кастрации раком простаты (mCSPC)

Название протокола
Клинические исследование Метастатический рак простаты, чувствительный к кастрату: Niraparib, Абиратерона ацетат (AA), Преднизон, Плацебо для Нирапариба - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Janssen Research & Development, LLC

Источник Janssen Research & Development, LLC
Краткое содержание

Цель исследования - определить, подходит ли комбинация нирапариба с абиратероном Ацетат (АК) плюс преднизон по сравнению с АК плюс преднизон у участников с Вредная зародышевая линия или соматическая гомологичная рекомбинационная репарация (HRR), мутированный в гене Метастатический Чувствительный к кастрации рак простаты (mCSPC) обеспечивает превосходную эффективность в улучшении рентгенографическая выживаемость без прогрессирования (rPFS).

Подробное описание

Рак простаты - гетерогенное заболевание, и недавние геномные анализы выявили: специфические мутации зародышевой линии и соматические мутации и альтернативные пути передачи сигналов роста в пациенты с метастатическим заболеванием. Абиратерона ацетат плюс преднизон (AA-P) установленный стандарт ухода за участниками с mCSPC и включен в общепринятые клинические рекомендации по лечению. Нирапариб - следственный агент в популяция рака, чувствительного к кастрации, и была одобрена для лечения яичников рак. Добавление нирапариба к основной схеме AA-P может улучшить исходное заболевание. контроль и отдаленные результаты по сравнению с одним AA-P в популяции, выбранной по биомаркеру. Исследование будет состоять из 4 этапов; Фаза предварительного скрининга для оценки биомаркеров на только право на участие, фаза скрининга, фаза лечения и фаза последующего наблюдения. Эффективность оценки включают следующее: измерения опухоли с помощью компьютерной томографии (КТ), магнитной резонансная томография (МРТ; брюшная полость, грудная клетка и таз), сканирование костей с технецием-99m (99mTc), сыворотка оценка чувствительного к простате антигена (ПСА) и результаты, сообщаемые пациентом (PRO). Безопасность оценки включают частоту нежелательных явлений и клинические лабораторные параметры.

Общий статус Рекрутинг
Дата начала 2020-09-23
Дата завершения 2027-05-07
Дата первичного завершения 2024-11-15
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Рентгенографическая выживаемость без прогрессирования (rPFS) До 47 месяцев
Вторичный результат
Мера Временное ограничение
Overall Survival (OS) Up to 78 months
Симптоматическая выживаемость без прогрессирования До 47 месяцев
Время до последующей терапии До 47 месяцев
Количество участников с нежелательными явлениями как показатель безопасности и переносимости До 78 месяцев
Регистрация 788
Состояние
  • Метастатический рак простаты, чувствительный к кастрату
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Niraparib

Описание: Participants will receive Niraparib 200 mg once daily.

Этикетка Arm Group: Niraparib with Abiraterone Acetate plus Prednisone (AA-P)

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Абиратерона ацетат (AA)

Описание: Участники будут получать 1000 мг АА один раз в день.

Этикетка Arm Group: Нирапариб с ацетатом абиратерона плюс преднизон (AA-P)

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Преднизон

Описание: Участники будут получать преднизон 5 мг один раз в день.

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Плацебо для Нирапариба

Описание: Участники будут получать плацебо для нирапариба один раз в день.

Этикетка Arm Group: AA плюс преднизон (AA-P)

Приемлемость

Критерии:

Критерии включения: - Патологическая диагностика аденокарциномы простаты - Должен иметь соответствующий вредный ген репарации гомологичной рекомбинации (HRR) изменение - Метастатическое заболевание, задокументированное обычными методами визуализации с помощью компьютерной томографии (КТ) или магнитно-резонансная томография (МРТ) (для поражений мягких тканей) или сканирование костей 99mTc (для костные поражения). Участники с единичным поражением кости на кости с технецием-99m (99mTc) сканирование без других метастатических заболеваний, не связанных с лимфоузлами, должно иметь подтверждение наличия кости метастазы при КТ или МРТ. Участники с поражением только лимфатических узлов не допускаются. - Андрогенная депривация (медицинская или хирургическая кастрация) должна быть началось> = 14 дней до рандомизации, и участники захотят продолжить андрогенная депривационная терапия (ADT) на протяжении фазы лечения - Другое разрешенное предшествующее лечение метастатического чувствительного к кастрации рака простаты (mCSPC): (а) максимум 1 курс облучения и 1 хирургическое вмешательство для симптоматический контроль рака простаты (например, неконтролируемая боль, надвигающийся спинальный сдавление пуповины или обструктивные симптомы). Участники с лучевой терапией или хирургическим вмешательством вмешательства во все известные места метастазирования будут исключены из исследования участие. Облучение должно быть завершено до рандомизации. (B) Максимум 6 месяцев ADT до рандомизации; (c) Максимум 45 дней абиратерона ацетат + преднизон (AA-P) до рандомизации (d) Максимум 2 недели кетоконазола при раке простаты до рандомизации Критерий исключения: - Предварительная обработка поли (аденозиндифосфат-рибоза) полимеразой (ингибитором) (PARP) ингибитор - История нарушения функции надпочечников - Длительный прием системно вводимых кортикостероидов (более [>] 5 миллиграммы [мг] преднизона или его эквивалента) во время исследования не допускается. Кратковременное использование (

Пол:

Мужчина

Минимальный возраст:

18 лет

Максимальный возраст:

N / A

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Общий контакт

Фамилия: Study Contact

Телефон: 844-434-4210

Расположение
Объект: Положение дел:
Urology Centers Of Alabama | Homewood, Alabama, 35209, United States Recruiting
Mayo Clinic Arizona | Phoenix, Arizona, 85054, United States Recruiting
Urological Associates of Southern Arizona, P.C. | Tucson, Arizona, 85741, United States Recruiting
Greater Los Angeles VA Healthcare System | Los Angeles, California, 90073, United States Not yet recruiting
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center | Orange, California, 92868, United States Not yet recruiting
San Bernardino Urological Associates | San Bernardino, California, 92404, United States Recruiting
UCSD Moores Cancer Center | San Diego, California, 92093-0987, United States Withdrawn
University of San Francisco California | San Francisco, California, 94115, United States Not yet recruiting
Rocky Mountain Cancer Centers | Colorado Springs, Colorado, 80907, United States Recruiting
The Urology Center of Colorado | Denver, Colorado, 80211, United States Recruiting
Colorado Permanente Medical Group | Denver, Colorado, 80230, United States Withdrawn
Foothills Urology - Golden Off | Lakewood, Colorado, 80228-2271, United States Recruiting
Advanced Urology Institute | Daytona Beach, Florida, 32114, United States Recruiting
University of Florida | Jacksonville, Florida, 32209, United States Recruiting
Cancer Specialists of North Florida | Jacksonville, Florida, 32256, United States Recruiting
First Urology | Jeffersonville, Indiana, 47130, United States Recruiting
Ochsner Clinic Foundation | New Orleans, Louisiana, 70121, United States Recruiting
Chesapeake Urology Associates | Towson, Maryland, 21204, United States Recruiting
Michigan Institute of Urology | Troy, Michigan, 48084, United States Recruiting
University of Mississippi Medical Center | Jackson, Mississippi, 39213, United States Withdrawn
Mosaic Life Care | Saint Joseph, Missouri, 64507, United States Recruiting
John Cochran VA | Saint Louis, Missouri, 63106, United States Not yet recruiting
GU Research Network | Omaha, Nebraska, 68130, United States Recruiting
New York Oncology Hematology | Albany, New York, 12206, United States Recruiting
Montefiore Medical Center | Bronx, New York, 10461, United States Recruiting
Memorial Sloan Kettering Cancer Center | Brooklyn, New York, 11203, United States Not yet recruiting
Memorial Sloan Kettering Cancer Center | Jamaica, New York, 11432, United States Not yet recruiting
Mount Sinai | New York, New York, 10029, United States Recruiting
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States Recruiting
Associated Medical Professionals | Syracuse, New York, 13210, United States Recruiting
Durham VAMC | Durham, North Carolina, 27705, United States Not yet recruiting
Stephenson Cancer Center | Oklahoma City, Oklahoma, 73104, United States Recruiting
VA Portland Health Care System | Portland, Oregon, 97239, United States Recruiting
Keystone Urology Specialists | Lancaster, Pennsylvania, 17604, United States Recruiting
University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States Recruiting
Thomas Jefferson University | Philadelphia, Pennsylvania, 19107, United States Withdrawn
University of Pittsburgh Medical Center (UPMC) | Pittsburgh, Pennsylvania, 15232, United States Recruiting
Ralph H. Johnson Veterans Affairs Medical Center | Charleston, South Carolina, 29401, United States Recruiting
Prisma Health | Seneca, South Carolina, 29672, United States Recruiting
West Cancer Center | Germantown, Tennessee, 38138, United States Withdrawn
Urology Associates | Nashville, Tennessee, 37209, United States Recruiting
Houston Metro Urology | Houston, Texas, 77027, United States Recruiting
Texas Oncology P.A. | New Braunfels, Texas, 78130, United States Recruiting
Texas Oncology-Tyler | Tyler, Texas, 75702, United States Recruiting
University of Utah Huntsman Cancer Institute | Salt Lake City, Utah, 84112, United States Recruiting
Virginia Oncology Associates | Norfolk, Virginia, 23502, United States Recruiting
Virginia Commonwealth University - Massey Cancer Center | Richmond, Virginia, 23298, United States Not yet recruiting
Urology of Virginia, PLCC | Virginia Beach, Virginia, 23462, United States Withdrawn
VA Puget Sound Healthcare System | Seattle, Washington, 98108, United States Not yet recruiting
Seattle Cancer Care Alliance | Seattle, Washington, 98109, United States Recruiting
CIPREC | Buenos Aires, C1119ACN, Argentina Not yet recruiting
Hospital Sirio Libanes | Buenos Aires, C1419AHN, Argentina Recruiting
Hospital Militar Cosme Argerich | C.a.b.a., C1426BOR, Argentina Recruiting
Hospital Aleman | Caba, 1118, Argentina Not yet recruiting
Centro de Urologia (CDU) | Ciudad Automoma Buenos Aires, C1120AAT, Argentina Recruiting
CINME - Centro de Investigaciones Metabolicas | Ciudad Autonoma de Buenos Aires, C1027AAP, Argentina Recruiting
Hospital Italiano de Buenos Aires | Ciudad Autonoma de, C1199ABB, Argentina Recruiting
Centro Oncológico Korben | Ciudad Autónoma de Buenos Aires, C1426AGE, Argentina Recruiting
Clínica Adventista Belgrano | Ciudad De Buenos Aires, C1430EGF, Argentina Recruiting
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Cordoba, 5000, Argentina Recruiting
Centro Urologico Profesor Bengio | Cordoba, X5000KPH, Argentina Recruiting
Hospital Privado de Cordoba | Cordoba, XX5016KEH, Argentina Recruiting
Hospital Privado de Comunidad | Mar Del Plata, B7602CBM, Argentina Recruiting
Centro de Investigacion Pergamino SA | Pergamino, B2700CPM, Argentina Recruiting
ARS Médica | San Salvador De Jujuy, Y4600AFW, Argentina Recruiting
Sunshine Coast University Hospital | Birtinya, Australia Recruiting
St. Vincent's Hospital Sydney | Darlinghurst, 2010, Australia Recruiting
Royal Brisbane and Women's Hospital | Herston, 4029, Australia Recruiting
Royal Hobart Hospital | Hobart, 7000, Australia Recruiting
Ashford Cancer Centre | Kurralta Park, 5037, Australia Recruiting
Liverpool Hospital | Liverpool, 2170, Australia Recruiting
Peter MacCallum Cancer Centre | Melbourne, 3000, Australia Recruiting
Fiona Stanley Hospital | Murdoch, 6150, Australia Recruiting
Macquarie University Hospital | North Ryde, 2109, Australia Recruiting
ICON Cancer Care | South Brisbane, 4101, Australia Recruiting
St John of God Subiaco Hospital | Subiaco, 6008, Australia Recruiting
Bobruisk Interregional Oncological Dispensary | Bobruisk, 213825, Belarus Recruiting
Brest Regional Oncology Dispensary | Brest, 224027, Belarus Recruiting
Gomel Regional Clinical Oncology Dispensary | Gomel, 246012, Belarus Recruiting
Grodno University Hospital | Grodno, 230017, Belarus Recruiting
State Institution N.N. Alexandrov Republican Scientific and | Lesnoy, 223040, Belarus Recruiting
Minsk city Clinical Oncological Dispensary | Minsk, 220013, Belarus Recruiting
Mogilev Regional Hospital | Mogilev, 212018, Belarus Recruiting
Vitebsk Regional Clinical Hospital | Vitebsk, 210603, Belarus Recruiting
ZNA Middelheim | Antwerp, 2020, Belgium Not yet recruiting
Grand Hôpital de Charleroi, site Notre Dame | Charleroi, 6000, Belgium Recruiting
Jolimont | Haine-St-Paul, 7100, Belgium Recruiting
CHC MontLegia | Liege, 4000, Belgium Recruiting
CHU UCL Namur - Site Sainte Elisabeth | Namur, 5000, Belgium Recruiting
Clinique St Pierre | Ottignies, 1340, Belgium Recruiting
Algemeen Ziekenhuis Delta | Roeselare, 8800, Belgium Recruiting
GZA Ziekenhuizen | Wilrijk, 2610, Belgium Recruiting
Hospital Do Cancer De Barretos - Fundacao Pio Xii | Barretos, 14784-400, Brazil Recruiting
Cetus Oncologia | Belo Horizonte, 30110-022, Brazil Recruiting
PERSONAL - Oncologia de Precisão e Personalizada | Belo Horizonte, 30130-090, Brazil Recruiting
CIONC - Centro Integrado de Oncologia de Curitiba | Curitiba, 80810-050, Brazil Recruiting
Centro de Pesquisas Oncológicas - CEPON | Florianópolis, 88034-000, Brazil Recruiting
Pronutrir | Fortaleza, 60 810180, Brazil Recruiting
Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás | Goiânia, 74605-070, Brazil Recruiting
Hospital de Caridade de Ijui - CACON | Ijui, 98700-000, Brazil Not yet recruiting
Fundação São Francisco Xavier | Ipatinga, 35162 189, Brazil Recruiting
Instituto Joinvilense De Hematologia e Oncologia | Joinville, 89201260, Brazil Recruiting
Liga Norte Riograndense Contra O Cancer | Natal, 59075-740, Brazil Recruiting
Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre, 90020-090, Brazil Recruiting
Hospital Ernesto Dornelles | Porto Alegre, 90160-093, Brazil Recruiting
MultiHemo | Recife, CEP: 50070-460, Brazil Recruiting
Instituto Nacional do Cancer - INCA | Rio de Janeiro, 20230-130, Brazil Recruiting
Hospital Universitário Pedro Ernesto | Rio de Janeiro, 20551-030, Brazil Recruiting
Oncoclínicas | Rio De Janeiro, 22250-905, Brazil Recruiting
Instituto COI de Pesquisa, Educacao e Gestao | Rio de Janeiro, 22793-080, Brazil Recruiting
Núcleo de Oncologia da Bahia | Salvador, 40170-110, Brazil Recruiting
Hospital Sao Rafael | Salvador, 41253-190, Brazil Recruiting
CEPHO - Faculdade de Medicina do ABC | Santo André, 09060-870, Brazil Recruiting
Centro de Pesquisa do Instituto do Cancer Arnaldo Vieira de Carvalho | Sao Paulo, 01221-020, Brazil Recruiting
Santa Casa de Misericordia de São Paulo | Sao Paulo, 01221-020, Brazil Recruiting
Instituto de Ensino E Pesquisa Sao Lucas | Sao Paulo, 01236-030, Brazil Recruiting
ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA | Sao Paulo, 01246-000, Brazil Recruiting
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado | Sorocaba, 18030-005, Brazil Recruiting
Hospital Samaritano de São Paulo | São Paulo, 01243-020, Brazil Withdrawn
Hospital Beneficência Portuguesa de São Paulo | São Paulo, 01323-001, Brazil Recruiting
Núcleo de Pesquisa São Camilo | São Paulo, 04014-002, Brazil Recruiting
Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO | São Paulo, 04039-004, Brazil Recruiting
MHAT Deva Maria | Burgas, 8001, Bulgaria Recruiting
UMHAT 'Dr. Georgi Stranski', EAD | Pleven, 5800, Bulgaria Withdrawn
UMHAT 'Dr. Georgi Stranski', EAD | Pleven, 5800, Bulgaria Recruiting
Complex Oncology Center - Plovdiv EOOD | Plovdiv, 4004, Bulgaria Withdrawn
District Oncology Dispensary with In-Patient Stationary - Plovdiv | Plovdiv, 4004, Bulgaria Recruiting
Specialized Hospital for Active Treatment in Oncology | Sofia, 1756, Bulgaria Recruiting
UMHAT Sofia Med | Sofia, 1797, Bulgaria Withdrawn
Comprehensive Cancer Center | Vratsa, 3001, Bulgaria Recruiting
Prostate Cancer Centre | Calgary, Alberta, T2V 1P9, Canada Recruiting
Cross Cancer Institute | Edmonton, Alberta, T6G 1Z2, Canada Recruiting
British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI) | Kelowna, British Columbia, V1Y 5L3, Canada Recruiting
British Columbia Cancer Agency (BCCA) - Vancouver Centre | Vancouver, British Columbia, V5Z 4E6, Canada Recruiting
British Columbia Cancer Agency - Vancouver Island Centre | Victoria, British Columbia, V8R 6V5, Canada Recruiting
McMaster Institute of Urology | Hamilton, Ontario, L8N 4A6, Canada Recruiting
Kingston Health Sciences Centre, Kingston General Health Research Institute | Kingston, Ontario, K7L2V7, Canada Recruiting
Sunnybrook Health Sciences Center | Toronto, Ontario, M4N 3M5, Canada Recruiting
University Health Network (UHN) Princess Margaret Cancer Centre | Toronto, Ontario, M5G 2M9, Canada Recruiting
Centre Hospitalier de l'Universite de Montreal | Montreal, Quebec, H2X 0A9, Canada Recruiting
McGill University - Jewish General Hospital | Montreal, Quebec, H3T 1E2, Canada Recruiting
Cancer Hospital Chinese Academy of Medical Sciences | Beijing, 100021, China Not yet recruiting
Peking University First Hospital | Beijing, 100034, China Not yet recruiting
Beijing Friendship Hospital, Capital Medical University | Beijing, 100050, China Recruiting
Beijing Cancer Hospital | Beijing, 100142, China Recruiting
Beijing University Third Hospital | Beijing, 100191, China Recruiting
Beijing Hospital | BeiJing, 100730, China Recruiting
Hunan Cancer hospital | Changsha, 410013, China Withdrawn
West China Hospital of Sichuan University | Chengdu, 610041, China Not yet recruiting
Sichuan Provincial People's Hospital | Chengdu, 610072, China Recruiting
Western Theater General Hospital of the Chinese People's Liberation Army | Chengdu, 610083, China Recruiting
Chongqing University Cancer Hospital | Chongqing, 400030, China Recruiting
Southwest Hospital, The Third Military Medical University | Chongqing, 400038, China Recruiting
Sun Yat-Sen University Cancer Center | GuangZhou, 430030, China Not yet recruiting
Guangzhou First Municipal People's Hospital | Guangzhou, 510180, China Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou, 510289, China Not yet recruiting
Zhejiang Provincial People's Hospital | Hangzhou, 310014, China Recruiting
The First Affiliated Hospital of NanChang University | Nanchang, 330006, China Recruiting
Jiangsu Province Cancer Hospital | Nanjing, 210000, China Not yet recruiting
Nanjing Drum Tower Hospital | Nanjing, 210008, China Recruiting
Ningbo First Hospital | Ningbo, 315010, China Recruiting
Fudan University Shanghai Cancer Center | Shanghai, 200032, China Recruiting
Zhongshan Hospital,Fudan University | Shanghai, 200032, China Not yet recruiting
Huashan Hospital Fudan University | Shanghai, 200040, China Recruiting
Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University | Shanghai, 200127, China Recruiting
The Fifth People's Hospital of Shanghai, Fudan University | Shanghai, 200240, China Recruiting
Huadong Hospital Affiliated to Fudan University | Shanghai, 200400, China Recruiting
Shengjing Hospital of China Medical University | Shenyang, 110004, China Recruiting
Second Affiliated Hospital of Soochow University | SuZhou, 200233, China Recruiting
The First Affliated Hospital of Soochow University | Suzhou, 215006, China Recruiting
The First Affiliated Hospital of Wenzhou Medical University | Wenzhou, 325000, China Recruiting
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology | Wuhan, 430030, China Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an, 710061, China Recruiting
Yantai Yuhuangding Hospital | Yantai, 264000, China Withdrawn
Fakultni nemocnice u sv. Anny v Brne | Brno, 656 91, Czechia Recruiting
FN Hradec Kralove, Urologicka klinika | Hradec Kralove, 500 05, Czechia Recruiting
Krajská nemocnice Liberec | Liberec, 460 63, Czechia Recruiting
Uromedical Center s.r.o. | Olomouc, 77900, Czechia Recruiting
Urologicka klinika 1.LF UK a VFN | Praha 2, 128 00, Czechia Recruiting
Thomayerova nemocnice | Praha 4, 140 59, Czechia Withdrawn
Aalborg University Hospital | Aalborg, 9000, Denmark Recruiting
Copenhagen University Hospital | Copenhagen, 2100, Denmark Recruiting
Herlev Hospital | Herlev, DK-2730, Denmark Recruiting
Næstved Hospital | Naestved, 4700, Denmark Recruiting
Odense Universitetshospital | Odense, DK-5000, Denmark Not yet recruiting
Vejle Hospital | Vejle, DK-7100, Denmark Recruiting
Institut de Cancérologie de l'Ouest (ICO) | Angers Cedex 9, 49933, France Recruiting
Institut Sainte Catherine | Avignon Cedex 9, 84918, France Recruiting
CHRU De Besancon | Besancon, 25030, France Recruiting
Institut Bergonié | Bordeaux, 33000, France Recruiting
Centre Georges François Leclerc | Dijon, 21000, France Recruiting
Centre Oscar Lambret | Lille, 59020, France Recruiting
Centre Leon Bérard | Lyon, 69008, France Recruiting
Hopital Prive Jean Mermoz | Lyon, 69008, France Recruiting
Hôpital Privé Clairval | Marseilli, 13009, France Not yet recruiting
Institut Regional du Cancer de Montpellier Val d'Aurelle | Montpellier, 34298, France Recruiting
Polyclinique de Gentilly | Nancy, 54100, France Recruiting
CHU De Poitiers | Poitiers Cedex, 86021, France Recruiting
Centre Hopitalier Inter-Communal De Cornouaille | Quimper, 29000, France Recruiting
Centre de radiothérapie et d'Oncologie médicale de l'Essonne | Ris Orangis, 91130, France Withdrawn
HIA Begin | Saint Mande, 94163, France Recruiting
Institut de Cancérologie de Loire | Saint-Priest-en-Jarez, 42271, France Recruiting
Clinique Sainte Anne | Strasbourg, 67000, France Not yet recruiting
Hopital Foch | Suresnes, 32151, France Recruiting
CHRU de Tours | Tours, 37044, France Recruiting
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer | Braunschweig, 38126, Germany Recruiting
Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I | Dresden, 01307, Germany Not yet recruiting
Urologicum Duisburg | Duisburg, 47179, Germany Not yet recruiting
Urologikum Hamburg | Hamburg, 22399, Germany Not yet recruiting
Medizinische Hochschule Hannover | Hannover, 30625, Germany Not yet recruiting
Universitaetsklinikum Koeln | Koeln, 50937, Germany Not yet recruiting
Urologie Neandertal Praxis Mettmann | Mettmann, 40822, Germany Withdrawn
Klinikum rechts der Isar - III. Med. Klinik und Poliklinik | Muenchen, 81675, Germany Not yet recruiting
Universitaetsklinikum Muenster | Muenster, 48149, Germany Not yet recruiting
Studienpraxis Urologie Drs. Feyerabend | Nuertingen, 72622, Germany Not yet recruiting
Semmelweis Egyetem, Urológia Klinika | Budapest, 1082, Hungary Withdrawn
Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály | Budapest, 1122, Hungary Withdrawn
Jahn Ferenc Del-pesti Korhaz es Rendelointezet | Budapest, 1204, Hungary Not yet recruiting
Uzsoki Utcai Korhaz | Budapest, H-1145, Hungary Withdrawn
Petz Aladar Megyei Oktato Korhaz | Gyor, 9024, Hungary Recruiting
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Gyula, 5700, Hungary Not yet recruiting
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz | Miskolc, 3526, Hungary Recruiting
Szegedi Tudomanyegyetem | Szeged, 6720, Hungary Recruiting
Szent Borbala Hospital Tatabanya | Tatabanya, 2800, Hungary Recruiting
Zala Megyei Szent Rafael Korhaz | Zalaegerszeg, 8900, Hungary Not yet recruiting
Haemek Medical Center - Afula | Afula, 1834111, Israel Recruiting
Soroka Hospital | Beer-Sheva, 85101, Israel Recruiting
Rambam Medical Center | Haifa, 31096, Israel Recruiting
Hadassah Hospital | Jerusalem, 91200, Israel Recruiting
Rabin Medical Center, Beilinson Hospital | Petach Tikvah, 49100, Israel Recruiting
Sheba Medical Center Tel Hashomer | Ramat Gan, 52621, Israel Recruiting
Tel-Aviv Sourasky Medical Center | Tel-Aviv, 64239, Israel Recruiting
Yitzhak Shamir Medical Center | Tzrifin, 70300, Israel Withdrawn
Ospedale S. Donato - Asl 8 Arezzo | Arezzo, 52100, Italy Recruiting
Divisione di Oncologia - Istituto per la ricerca e cura del cancro | Candiolo, 10060, Italy Recruiting
Istituti Ospitalieri di Cremona, AO di Cremona | Cremona, 26100, Italy Recruiting
Azienda Ospedaliera ''Vito Fazzi'' | Lecce, 73100, Italy Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola, 47014, Italy Recruiting
Ospedale San Raffaele | Milano, 20132, Italy Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori | Milano, 20133, Italy Recruiting
European Institute of Oncology | Milano, 20141, Italy Recruiting
Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS | Napoli, 80138, Italy Recruiting
Aou San Luigi Gonzaga | Orbassano, 10043, Italy Recruiting
Istituto Oncologico Veneto Iov Irccs Padova | Padova, 35128, Italy Recruiting
Azienda Ospedaliero Universitaria Pisana | Pisa, 56126, Italy Recruiting
ASL Napoli 2 Nord-SM delle Grazie Hospital | Pozzuoli, 80078, Italy Recruiting
Casa Sollievo della Sofferenza, IRCCS | San Giovanni Rotondo, 71013, Italy Recruiting
Ospedale S. Chiara | Trento, Italy Recruiting
Ospedale San Bortolo | Vicenza, Italy Recruiting
Pusan National University Hospital | Busan, 49241, Korea, Republic of Recruiting
Kyungpook National University Chilgok Hospital | Daegu, 41404, Korea, Republic of Recruiting
Keimyung University Dongsan Hospital | Daegu, 42601, Korea, Republic of Recruiting
Chungnam National University Hospital | Daejeon, 35015, Korea, Republic of Recruiting
National Cancer Center | Goyang-si, 10408, Korea, Republic of Recruiting
Chonnam National University Hospital | Gwangju, 61469, Korea, Republic of Recruiting
Seoul National University Bundang Hospital | Seongnam-si, 13620, Korea, Republic of Recruiting
Seoul National University Hospital | Seoul, 03080, Korea, Republic of Recruiting
Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea, Republic of Recruiting
Asan Medical Center | Seoul, 05505, Korea, Republic of Recruiting
Gangnam Severance Hospital | Seoul, 06273, Korea, Republic of Recruiting
Samsung Medical Center | Seoul, 06351, Korea, Republic of Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul, 06591, Korea, Republic of Recruiting
Ajou University Hospital | Suwon, 16499, Korea, Republic of Recruiting
Hospital Pulau Pinang | George Town, 10990, Malaysia Recruiting
Hospital Sultan Ismail | Johor Bahru, 81100, Malaysia Recruiting
Hospital Kuala Lumpur | Kuala Lumpur N/a, 50586, Malaysia Recruiting
University Malaya Medical Centre | Kuala Lumpur, 59120, Malaysia Recruiting
Sarawak General Hospital | Kuching, 93586, Malaysia Recruiting
Institut Kanser Negara - Clinical Research Center | Putrajaya, 62250, Malaysia Recruiting
Centro de Investigación Clínica Gramel S.C. | Ciudad de Mexico, 3720, Mexico Not yet recruiting
Consultorio de Especialidad en Urologia Privado | Durango, 34000, Mexico Recruiting
Consultorio Privado | Leon, 37000, Mexico Not yet recruiting
Avix Investigacion Clinica, S.C. | Monterrey, 64710, Mexico Not yet recruiting
i Can Oncology Center | Monterrey, 64710, Mexico Not yet recruiting
Oncología Integral Satelite | Naucalpan, 53100, Mexico Not yet recruiting
Consultorio de Oncología Médica | Oaxaca, 68020, Mexico Recruiting
Consultorio Privado | Zapopan, 45040, Mexico Not yet recruiting
Reinier de Graaf Gasthuis | Delft, 2625 AD, Netherlands Recruiting
Tergooiziekenhuizen | Hilversum, 1213XZ, Netherlands Recruiting
UMC Radboud | Nijmegen, 6525AG, Netherlands Withdrawn
Canisius-Wilhelminaziekenhuis | Nijmegen, 6532 SZ, Netherlands Recruiting
Elisabeth-TweeSteden Ziekenhuis | Tilburg, 5022 GC, Netherlands Recruiting
Auckland City Hospital | Auckland, 1023, New Zealand Recruiting
Canterbury Urology Research Trust | Christchurch, 8013, New Zealand Recruiting
Dunedin Hospital | Dunedin Central, 9016, New Zealand Recruiting
Tauranga Hospital | Tauranga, 3112, New Zealand Recruiting
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza | Bydgoszcz, 85-094, Poland Recruiting
Centrum Onkologii im. Prof. F. Lukaszczyka | Bydgoszcz, 85-796, Poland Recruiting
Szpitale Pomorskie Sp. z o.o. | Gdynia, 81-519, Poland Recruiting
Przychodnia Lekarska KOMED Roman Karaszewski | Konin, 62-500, Poland Recruiting
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi | Lodz, 93-509, Poland Recruiting
Urologica Praktyka Lekarska Adam Marcheluk | Siedlce, 08-110, Poland Recruiting
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. | Warszawa, 04-073, Poland Recruiting
Specjalistyczna przychodnia lekarska POLIMED | Wroclaw, 53-329, Poland Recruiting
Hosp. Garcia de Orta | Almada, 2805-607, Portugal Recruiting
Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A. | Coimbra, 3000075, Portugal Recruiting
Fundação Champalimaud | Lisboa, 1400-038, Portugal Recruiting
Chln - Hosp. Santa Maria | Lisboa, 1649-035, Portugal Recruiting
Altai Regional Oncology Dispensary | Barnaul, 656045, Russian Federation Recruiting
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine | Chelyabinsk, 454087, Russian Federation Not yet recruiting
Ivanovo Regional Oncology Dispensary | Ivanovo, 153040, Russian Federation Recruiting
GUZ Kursk Regional Oncology Dispensary | Kursk, 305524, Russian Federation Withdrawn
Russian Scientific Center of Roentgenoradiology | Moscow, 117997, Russian Federation Withdrawn
Moscow City Clinical Hospital # 62 | Moscow, 125130, Russian Federation Recruiting
Hertzen Oncology Research Institute | Moscow, 125284, Russian Federation Recruiting
Privolzhsky District Medical Centre | Nizhny Novgorod, 603074, Russian Federation Recruiting
Clinical Oncology Dispensary | Omsk, 644013, Russian Federation Recruiting
LLC Novaya Clinica | Pyatigorsk, 357500, Russian Federation Recruiting
Pyatigorsk Regional Oncology Dispensary | Pyatigorsk, 357502, Russian Federation Recruiting
Private Medical Institution Euromedservice | Saint Petersburg, 196603, Russian Federation Recruiting
Leningrad Regional Oncology Dispensary | Saint-Petersburg, 191104, Russian Federation Recruiting
Russian Scientific Center of Radiology and Surgical Technologies | Saint-Petersburg, 197758, Russian Federation Not yet recruiting
Republican Oncology Dispensary | Saransk, 430032, Russian Federation Recruiting
Oncologic Dispensary No.2 | Sochi, 354057, Russian Federation Withdrawn
Tomsk Cancer Research Institute | Tomsk, 634050, Russian Federation Recruiting
Multifunctional clinical medical center 'Medical city' | Tyumen, 625041, Russian Federation Recruiting
Bashkir State Medical University | Ufa, 450083, Russian Federation Recruiting
CancerCare Rondebosch | Cape Town, 7700, South Africa Recruiting
Steve Biko Academic Hospital | Pretoria, 0001, South Africa Not yet recruiting
East Rand Urology Research Unit | Vosloorus, 1475, South Africa Recruiting
Hosp. Univ. A Coruña | A Coruña, 15006, Spain Recruiting
Hosp. de La Santa Creu I Sant Pau | Barcelona, 08025, Spain Recruiting
Hosp. Clinic I Provincial de Barcelona | Barcelona, 08036, Spain Recruiting
Hosp. Gral. Univ. de Castellon | Castellon, 12004, Spain Recruiting
Institut Català D'Oncologia Girona | Girona, 17007, Spain Recruiting
Hosp. de Jerez de La Frontera | Jerez de la Frontera, 11407, Spain Recruiting
Hosp. Univ. de La Princesa | Madrid, 28006, Spain Recruiting
Hosp. Univ. Ramon Y Cajal | Madrid, 28034, Spain Recruiting
Hosp. Univ. 12 de Octubre | Madrid, 28041, Spain Recruiting
Hosp. Univ. La Paz | Madrid, 28046, Spain Recruiting
Hosp. Univ. Hm Monteprincipe | Madrid, 28660, Spain Recruiting
Hosp. Virgen de La Victoria | Málaga, 29010, Spain Recruiting
Corporacio Sanitari Parc Tauli | Sabadell, 08208, Spain Recruiting
Hosp. Univ. Marques de Valdecilla | Santander, 39008, Spain Recruiting
Hosp. Virgen Del Rocio | Sevilla, 41013, Spain Recruiting
Hosp. Clinico Univ. de Valencia | Valencia, 46010, Spain Recruiting
Salgrenska University hospital | Göteborg, 413 45, Sweden Recruiting
Urologiska Mottagningen | Malmö, 205 02, Sweden Recruiting
Södersjukhuset | Stockholm, 11883, Sweden Recruiting
Karolinska Universitetssjukhuset Solna | Stockholm, 17164, Sweden Recruiting
Akademiska Sjukhuset | Uppsala, 751 85, Sweden Withdrawn
Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City, 83301, Taiwan Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung, 807, Taiwan Recruiting
China Medical University Hospital | Taichung, 40447, Taiwan Recruiting
Taichung Veterans General Hospital | Taichung, 40705, Taiwan Recruiting
Tungs' Taichung MetroHarbor Hospital | Taichung, 435, Taiwan Recruiting
National Taiwan University Hospital. | Taipei, 10002, Taiwan Recruiting
Taipei Veterans General Hospital | Taipei, 11217, Taiwan Recruiting
Chang-Gung Memorial Hospital, LinKou Branch | Taoyuan, 333, Taiwan Recruiting
King Chulalongkorn Memorial Hospital | Bangkok, 10330, Thailand Recruiting
Ramathibodi Hospital | Bangkok, 10400, Thailand Recruiting
Siriraj Hospital | Bangkok, 10700, Thailand Recruiting
Adana Baskent Yuregir Hospital | Adana, 01250, Turkey Not yet recruiting
Memorial Ankara Hastanesi | Ankara, 06520, Turkey Recruiting
Ankara University Medical Faculty | Ankara, 06590, Turkey Not yet recruiting
Ankara Bilkent City Hospital | Ankara, 06800, Turkey Recruiting
Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi | Bursa, 16310, Turkey Recruiting
Istanbul University Istanbul Medical Faculty | Istanbul, 34000, Turkey Recruiting
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd | Istanbul, 34098, Turkey Recruiting
T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi | Istanbul, 34722, Turkey Recruiting
Dokuz Eylul University Medical Faculty | Izmir, 35340, Turkey Recruiting
Izmir Medical Park Hospital | Izmir, 35530, Turkey Recruiting
Manisa Celal Bayar University | Manisa, 45030, Turkey Withdrawn
Sakarya University Training and Research Hospital | Sakarya, 54100, Turkey Recruiting
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' | Cherkasy, 18009, Ukraine Recruiting
Municipal Non-profit enterprise 'Bukovinian clinical oncology center' | Chernivtsi, 58013, Ukraine Recruiting
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc | Dnipro, 49005, Ukraine Recruiting
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council | Dnipro, 49100, Ukraine Recruiting
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4 | Dnipro, 49102, Ukraine Recruiting
Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk, 76008, Ukraine Recruiting
Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council | Kamianske, 51900, Ukraine Recruiting
Municipal non-profit enterprise 'Regional Center of Oncology' | Khakhiv, 61070, Ukraine Recruiting
Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval | Kharkiv, 61037, Ukraine Recruiting
Kherson Regional Oncological Dispensary | Kherson, 73035, Ukraine Recruiting
State Institution National Cancer Institute | Kyiv, 03022, Ukraine Recruiting
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center | Kyiv, 03115, Ukraine Recruiting
Kyiv Regional Oncological Dispensary | Kyiv, 04107, Ukraine Recruiting
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' | Lviv, 79010, Ukraine Recruiting
Podilskiy Regional Center of Oncology | Vinnitsa, 21029, Ukraine Recruiting
Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council | Zhytomyr, 10002, Ukraine Recruiting
Belfast City Hospital | Belfast, BT9 7AB, United Kingdom Recruiting
Brighton and Sussex University Hospitals NHS Trust | Brighton, BN2 5BE, United Kingdom Recruiting
Bristol Haematology and Oncology Centre | Bristol, BS2 8ED, United Kingdom Not yet recruiting
Guy's Hospital | Great Maze Pond, SE1 9RT, United Kingdom Not yet recruiting
Marie Curie Research Wing - Mount Vernon Hospital | Hillingdon, HA6 2RN, United Kingdom Recruiting
University College London Hospitals NHSFT | London, NW1 2PG, United Kingdom Recruiting
Churchill Hospital | Oxford, OX3 7LE, United Kingdom Recruiting
Royal Preston Hospital | Preston, PR2 9HT, United Kingdom Recruiting
Royal Marsden Hospital | Sutton, SM2 5PT, United Kingdom Recruiting
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital | Truro, TR1 3LJ, United Kingdom Recruiting
Расположение Страны

Argentina

Australia

Belarus

Belgium

Brazil

Bulgaria

Canada

China

Czechia

Denmark

France

Germany

Hungary

Israel

Italy

Korea, Republic of

Malaysia

Mexico

Netherlands

New Zealand

Poland

Portugal

Russian Federation

South Africa

Spain

Sweden

Taiwan

Thailand

Turkey

Ukraine

United Kingdom

United States

Дата проверки

2021-12-01

Ответственная сторона

Тип: Спонсор

Имеет расширенный доступ Нет
Количество рук 2
Группа вооружений

Метка: Niraparib with Abiraterone Acetate plus Prednisone (AA-P)

Тип: Experimental

Описание: 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.

Метка: AA плюс преднизон (AA-P)

Тип: Экспериментальный

Описание: В каждом 28-дневном цикле лечения участники будут получать следующее: плацебо для нирапариба вместе с 1000 мг AA плюс 5 мг преднизона один раз в день.

Акроним AMPLITUDE
Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Двойник (участник, исследователь)