Badanie talazoparybu z enzalutamidem u mężczyzn ze zmutowanym genem DDR mCSPC
TALAPRO-3: FAZA 3, RANDOMIZOWANE, PODWÓJNIE ZAŚLEPANE BADANIE TALAZOPARYBU Z ENZALUTAMIDEM W KONTRASCIE PLACEBO Z ENZALUTAMIDEM U MĘŻCZYZN Z ZMUTOWANYM GENEM DDR, WRAŻLIWYM NA KASTRACJĘ RAKIEM PROSTATY Z PRZErzutami
The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The study will have 5 periods: prescreening, screening, double-blind treatment, safety follow-up, and long-term follow-up.
Approximately 550 men with mCSPC will be randomized. Eligible participants will be randomly assigned to either of 2 treatment groups as follows:
- Talazoparib in combination with enzalutamide.
- Placebo capsules identical in appearance to talazoparib capsules in combination with enzalutamide.
Talazoparib or identical placebo treatment will be blinded. Enzalutamide (160 mg/day) will be open label. The dose of talazoparib/placebo to be given in combination with enzalutamide is 0.5 mg once daily. Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m2 by the MDRD equation) at screening may be enrolled and the talazoparib/placebo dose will be 0.35 mg once daily.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Gauteng
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Johannesburg, Gauteng, Afryka Południowa, 2193
- Charlotte Maxeke Johannesburg Academic Hospital
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Johannesburg, Gauteng, Afryka Południowa, 2193
- 15 Eton Road
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Johannesburg, Gauteng, Afryka Południowa, 2193
- WCR Office
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Johannesburg, Gauteng, Afryka Południowa, 2196
- Sandton Oncology Medical Group (Pty) Ltd
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Parktown, Gauteng, Afryka Południowa, 2193
- Wits Clinical Research
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Pretoria, Gauteng, Afryka Południowa, 0002
- Clinical Research Unit, University of Pretoria
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CABA, Argentyna, C1426ANZ
- Instituto Médico Especializado Alexander Fleming
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Caba, Argentyna, C1426AGE
- Centro Oncologico Korben
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Córdoba, Argentyna, X5008HHW
- Centro Medico Privado CEMAIC
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Buenos Aires
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Berazategui, Buenos Aires, Argentyna, B1884BBF
- COIBA
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Pergamino, Buenos Aires, Argentyna, B2700CPM
- Centro de Investigacion Pergamino SA - Clinica Pergamino SA
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Río Negro Province
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Viedma, Río Negro Province, Argentyna, R8500ACE
- Centro de Investigaciones Clínicas - Clínica Viedma
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentyna, T4000IAK
- Centro Medico San Roque
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Chris O'Brien Lifehouse
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Wollongong, New South Wales, Australia, 2500
- Cancer Care Wollongong Pty Limited
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Queensland
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Brisbane, Queensland, Australia, 4120
- Gallipoli Medical Research Foundation, Greenslopes Private Hospital
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Southport, Queensland, Australia, 4215
- Gold Coast University Hospital
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South Australia
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Woodville South, South Australia, Australia, 5011
- The Queen Elizabeth Hospital
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Victoria
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East Melbourne, Victoria, Australia, 3002
- Epworth Freemasons-Epworth HealthCare
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Malvern, Victoria, Australia, 3144
- Cabrini Hospital
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Richmond, Victoria, Australia, 3121
- Epworth Foundation Trading as Epworth HealthCare
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St Albans, Victoria, Australia, 3021
- Western Health, Sunshine Hospital
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Aalst, Belgia, 9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Anderlecht, Belgia, 1070
- Institut Jules Bordet
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Brussels, Belgia, 1200
- Cliniques universitaires Saint-Luc
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Brussels, Belgia, 1000
- Institut Jules Bordet
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Ghent, Belgia, 9000
- AZ (Algemeen Ziekenhuis) Maria Middelares
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Ghent, Belgia, 9000
- AZ (Algemeen Ziekenhuis) Sint-Lucas
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Kortrijk, Belgia, 8500
- AZ (Algemeen Ziekenhuis) Groeninge
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Liège, Belgia, 4000
- CHU de Liege
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Merksem, Belgia, 2170
- ZNA Jan Palfijn
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Panagyurishte, Bułgaria, 4500
- Multiprofile Hospital for Active Treatment - Uni Hospital OOD
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Plovdiv, Bułgaria, 4000
- Complex Oncology Center - Plovdiv EOOD
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Plovdiv, Bułgaria, 4000
- Independent medical-diagnostic laboratory "Medisken" EOOD
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Plovdiv, Bułgaria, 4000
- Complex Oncology Center- Plovdiv EOOD
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Shumen, Bułgaria, 9700
- Complex Oncology Center - Shumen EOOD
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Sofia, Bułgaria, 1407
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
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Sofia, Bułgaria
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
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Stara Zagora, Bułgaria, 6003
- Complex Oncology Center - Stara Zagora Ltd.
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Stara Zagora, Bułgaria, 6003
- MRI SMDLOD "Mediscan" Ltd
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Stara Zagora, Bułgaria, 6003
- UMHAT "Prof. Dr. Stoyan Kirkovich"
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Chongqing, Chiny, 400042
- The First Affiliated Hospital Chongqing Medical University
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Guangzhou, Chiny, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Anhui
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Hefei, Anhui, Chiny, 230022
- The First Affiliated Hospital of Anhui Medical University
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Beijing Municipality
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Beijing, Beijing Municipality, Chiny, 100034
- Peking University First Hospital
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Gansu
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Lanzhou, Gansu, Chiny, 730030
- Lanzhou university second hospital
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Guangdong
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Guangzhou, Guangdong, Chiny, 510515
- Nanfang Hospital of Southern Medical University
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Guangzhou, Guangdong, Chiny, 510230
- The First Affiliated Hospital of Guangzhou Medical University
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Henan
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Zhengzhou, Henan, Chiny, 450003
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, Chiny, 430079
- Hubei Cancer Hospital
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Wuhan, Hubei, Chiny, 430022
- Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
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Wuhan, Hubei, Chiny, 430030
- Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Chiny, 410013
- Hunan Cancer Hospital
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Changsha, Hunan, Chiny, 410013
- The Third Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, Chiny, 210009
- Zhongda Hospital Southeast University
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Nantong, Jiangsu, Chiny, 226000
- Nantong Tumor Hospital
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Suzhou, Jiangsu, Chiny, 215004
- The Second Affiliated Hospital of Soochow University
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Jiangxi
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Nanchang, Jiangxi, Chiny, 330029
- Jiangxi Provincial Cancer Hospital
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Jilin
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Changchun, Jilin, Chiny, 130021
- The First hospital of Jilin University
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Shaanxi
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Xi'an, Shaanxi, Chiny, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chiny, 200032
- Fudan University Cancer Hospital
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Sichuan
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Chengdu, Sichuan, Chiny, 610041
- West China Hospital of Sichuan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Chiny, 300211
- The Second Hospital of Tianjin Medical University
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Zhejiang
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Hangzhou, Zhejiang, Chiny, 310014
- Zhejiang Provincial People's Hospital
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Ningbo, Zhejiang, Chiny, 315010
- The first affiliated hospital of Ningbo university
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Wenzhou, Zhejiang, Chiny, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Olomouc, Czechy, 779 00
- Fakultni nemocnice Olomouc
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Ostrava - Poruba, Czechy, 708 52
- Fakultni nemocnice Ostrava
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Prague, Czechy, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Prague, Czechy, 150 00
- Fakultni Nemocnice Motol a Homolka
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Praha 8- Liben, Czechy, 180 81
- Fakultni nemocnice Bulovka
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Helsinki, Finlandia, 00029
- Helsinki University Hospital
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Helsinki, Finlandia, 00180
- Docrates Cancer Center
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Helsinki, Finlandia, 00280
- Clinical Research Institute Helsinki University Central Hospital Ltd
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Kuopio, Finlandia, 70210
- Kuopio University Hospital
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Tampere, Finlandia, 33520
- Tampere University Hospital
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Turku, Finlandia, 20520
- Turku University Hospital
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Angers, Francja, 49933
- Centre Hospitalier Universitaire d'Angers
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Bayonne, Francja, 64100
- Clinique Belharra
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Lille, Francja, 59000
- Hopital Prive le Bois
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Lyon, Francja, 69373
- Centre Leon Berard
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Paris, Francja, 75018
- Hopital Bichat - Claude Bernard
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Paris, Francja, 75877
- Hopital Bichat - Claude Bernard
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Pierre-Bénite, Francja, 69310
- Hopital Lyon Sud
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Quint-Fonsegrives, Francja, 31130
- Clinique La Croix du Sud - Ramsay Sante
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Reims, Francja, 51726
- Institut Jean Godinot
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Saint-Grégoire, Francja, 35760
- CHP Saint-Grégoire
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Strasbourg, Francja, 67200
- Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)
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Vandœuvre-lès-Nancy, Francja, 54519
- Institut de cancerologie de Lorraine
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Villejuif, Francja, 94805
- Gustave Roussy
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Brittany Region
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Brest, Brittany Region, Francja, 29200
- CHU Morvan de Brest
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Pays de la Loire Region
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Le Mans, Pays de la Loire Region, Francja, 72000
- Clinique Victor Hugo Le Mans
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Île-de-France Region
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Créteil, Île-de-France Region, Francja, 94010
- Hopital Henri Mondor
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Barcelona, Hiszpania, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Hiszpania, 08036
- Hospital Clínic de Barcelona
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Córdoba, Hiszpania, 14004
- Hospital Universitario Reina Sofía
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Madrid, Hiszpania, 28040
- Hospital Clinico San Carlos
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Madrid, Hiszpania, 28033
- MD Anderson Cancer Center
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Madrid, Hiszpania, 28009
- Hospital Universitario Gregorio Marañón
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Seville, Hiszpania, 41009
- Hospital Universitario Virgen de la Macarena
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Valencia, Hiszpania, 46026
- Hospital Politecnic Universitari La Fe
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Alicante
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Elche, Alicante, Hiszpania, 03203
- Hospital General Universitario de Elche
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Hiszpania, 08908
- Institut Català d'Oncologia de l'Hospitalet
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Manresa, Barcelona, Hiszpania, 08243
- Althaia, Xarxa Assistencial Universitària de Manresa
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Barcelona [barcelona]
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Badalona, Barcelona [barcelona], Hiszpania, 08916
- Hospital Germans Trias i Pujol
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Galicia
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Lugo, Galicia, Hiszpania, 27003
- Hospital Universitario Lucus Augusti
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Madrid, Comunidad de
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Majadahonda, Madrid, Comunidad de, Hiszpania, 28222
- Hospital Universitario Puerta de Hierro
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Navarre
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Pamplona, Navarre, Hiszpania, 31008
- Complejo Hospitalario de Navarra
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Principality of Asturias
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Oviedo, Principality of Asturias, Hiszpania, 33011
- Hospital Universitario Central de Asturias
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Tarragona
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Reus, Tarragona, Hiszpania, 43204
- Hospital Universitari Sant Joan de Reus
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, Hiszpania, 46009
- Fundación Instituto Valenciano de Oncología
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The Hague, Holandia, 2545 AA
- Stichting HagaZiekenhuis
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Utrecht
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Amersfoort, Utrecht, Holandia, 3813 TZ
- Meander Medisch Centrum
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New Delhi, Indie, 600028
- Indraprastha Apollo Hospitals
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Gujarat
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Surat, Gujarat, Indie, 395009
- Gujarat Hospital - Gastro and Vascular Centre
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Haryana
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Gurugram, Haryana, Indie, 122001
- Medanta- The Medicity hospital
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Gurugram, Haryana, Indie, 122001
- Artemis hospital
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Maharashtra
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Mumbai, Maharashtra, Indie, 401107
- Bhaktivedanta Hospital and Research Institute
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Pune, Maharashtra, Indie, 411004
- Sahyadri Super Speciality Hospital
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Pune, Maharashtra, Indie, 411004
- Sahyadri Clinical Research & Development Centre
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Pune, Maharashtra, Indie, 411038
- Sahyadri Hospitals Private Limited
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, Indie, 110076
- Indraprastha Apollo Hospital
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New Delhi, National Capital Territory of Delhi, Indie, 110085
- Rajiv Gandhi Cancer Institute and Research Centre
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Uttar Pradesh
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Meerut, Uttar Pradesh, Indie, 250001
- Valentis Cancer Hospital
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West Bengal
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Kolkata, West Bengal, Indie, 700094
- Netaji Subhas Chandra Bose Cancer Hospital
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-
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Kagoshima, Japonia, 890-8520
- Kagoshima University Hospital
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Kumamoto, Japonia, 860-0008
- National Hospital Organization Kumamoto Medical Center
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Tokushima, Japonia, 770-8503
- Tokushima University Hospital
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Yamagata, Japonia, 990-9585
- Yamagata University Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japonia, 466-8560
- Nagoya University Hospital
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Aomori
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Hirosaki, Aomori, Japonia, 036-8563
- Hirosaki University School of Medicine & Hospital
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Chiba
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Chiba, Chiba, Japonia, 2608717
- Chiba cancer center
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Kashiwa, Chiba, Japonia, 277-8577
- National Cancer Center Hospital East
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Ehime
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Matsuyama, Ehime, Japonia, 791-0280
- National Hospital Organization Shikoku Cancer Center
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Fukuoka
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Fukuoka, Fukuoka, Japonia, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Hiroshima
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Kure, Hiroshima, Japonia, 737-0023
- National Hospital Organization Kure Medical Center and Chugoku Cancer Center
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Hokkaido
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Sapporo, Hokkaido, Japonia, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Sapporo, Hokkaido, Japonia, 060-8648
- Hokkaido University Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japonia, 920-8641
- Kanazawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japonia, 232-0024
- Yokohama City University Medical Center
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Yokosuka, Kanagawa, Japonia, 238-8558
- Yokosukakyosai
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Osaka
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Osaka, Osaka, Japonia, 5418567
- Osaka International Cancer Institute
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Sakai, Osaka, Japonia, 590-0197
- Kindai University Hospital
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Suita, Osaka, Japonia, 565-0871
- The University of Osaka Hospital
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Shizuoka
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Hamamatsu, Shizuoka, Japonia, 431-3192
- Hamamatsu University Hospital
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Tokyo
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Meguro-Ku, Tokyo, Japonia, 152-8902
- National Hospital Organization Tokyo Medical Center
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Shinjuku-ku, Tokyo, Japonia, 160-8582
- Keio university hospital
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Alberta
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Calgary, Alberta, Kanada, T2V 1P9
- Prostate Cancer Centre
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 2Y9
- Centre of Applied Urology Research, Nova Scotia Health Authority
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Ontario
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London, Ontario, Kanada, N6A 5W9
- London Health Sciences Centre
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London, Ontario, Kanada, N6C2R5
- Organisation Lawson Health Research Institute
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Ottawa, Ontario, Kanada, K1H 8L6
- The Ottawa Hospital Cancer Center
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Toronto, Ontario, Kanada, M5G 2M9
- University Health Network-Princess Margaret Cancer Centre
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Quebec
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Chicoutimi, Quebec, Kanada, G7H 5H6
- CIUSSS- saguenay-Lac-Saint-Jean
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Chicoutimi, Quebec, Kanada, G7H 7K9
- Centre integre universitaire de sante et de services sociaux Saguenay-Lac-Saint-Jean
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Greenfield Park, Quebec, Kanada, J4V 2H3
- Urology South Shore Research
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Montreal, Quebec, Kanada, H3T 1E2
- Jewish General Hospital
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Montreal, Quebec, Kanada, H4A 3J1
- McGill University Health Center
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Montreal, Quebec, Kanada, H2X 0A9
- Centre Hospitalier de I'Universite de Montreal (CHUM)
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Montreal, Quebec, Kanada, H2X 0A9
- CHUM - Centre Hospitalier de l'Université de Montréal
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Daegu, Korea Południowa, 41404
- Kyungpook National University Chilgok Hospital
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Seoul, Korea Południowa, 03080
- Seoul National University Hospital
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Seoul, Korea Południowa, 05505
- Asan Medical Center
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Seoul, Korea Południowa, 06351
- Samsung Medical Center
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Seoul, Korea Południowa, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Korea Południowa, 06591
- The Catholic Univ. of Korea Seoul St. Mary's Hospital
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Seoul, Korea Południowa, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Korea Południowa, 07985
- Ewha Womans University Mokdong Hospital
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea Południowa, 10408
- National Cancer Center
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Jeollanam-do
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Hwasun-gun, Jeollanam-do, Korea Południowa, 58128
- Chonnam National University Hwasun Hospital
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Kyǒnggi-do
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Seongnam, Kyǒnggi-do, Korea Południowa, 13620
- Seoul National University Bundang Hospital
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Oaxaca City, Meksyk, 68020
- Centro de Investigacion Clinica de Oaxaca
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Veracruz, Meksyk, 91851
- Instituto Veracruzano en Investigación Clínica S.C.
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Guanajuato
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León, Guanajuato, Meksyk, 37178
- Preparaciones Oncológicas S.C.
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Nuevo León
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Monterrey, Nuevo León, Meksyk, 64460
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
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Monterrey, Nuevo León, Meksyk, 64040
- Axis Heilsa S. de R.L. de C.V.
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Oaxaca
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Oaxaca City, Oaxaca, Meksyk, 68000
- Oaxaca Site Management Organization
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State of Mexico
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Naucalpan, State of Mexico, Meksyk, 53100
- Oncologia Integral Satelite SA de CV
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Berlin, Niemcy, 10117
- Charite Universitaetsmedizin Berlin - Campus Mitte
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Duisburg, Niemcy, 47169
- Urologicum Duisburg
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Frankfurt, Niemcy, 60590
- Universitaetsklinikum Frankfurt
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Göttingen, Niemcy, 37075
- Institut fuer Diagnostische und Interventionelle Radiologie
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Göttingen, Niemcy, 37075
- Klinik fuer Nuklearmedizin
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Heidelberg, Niemcy, 69120
- Universitaetsklinik Heidelberg
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Leipzig, Niemcy, 04105
- Uro-/Onkologisches Zentrum
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Nürtingen, Niemcy, 72622
- Studienpraxis Urologie
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Tübingen, Niemcy, 72076
- Universitaetsklinikum Tuebingen
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Lower Saxony
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Göttingen, Lower Saxony, Niemcy, 37075
- Universitaetsmedizin Goettingen
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North Rhine-Westphalia
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Wesel, North Rhine-Westphalia, Niemcy, 46483
- Urologische Gemeinschaftspraxis Wesel
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Thuringia
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Jena, Thuringia, Niemcy, 07747
- Universitätsklinikum Jena
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-
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Gjøvik, Norwegia, 2819
- Sykehuset Innlandet Gjoevik
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-
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-
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Chelyabinsk, Rosja, 454048
- Evimed Llc
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Chelyabinsk, Rosja, 454087
- SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
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Ivanovo, Rosja, 153040
- Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")
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Moscow, Rosja, 117997
- Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of the
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Moscow, Rosja, 121205
- Branch of the Limited Liability Company "Hadassah Medical Ltd."
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Moscow, Rosja, 121359
- Federal State Budgetary Institution "Central Clinical Hospital with ambulance"
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Omsk, Rosja, 644013
- BHI of Omsk region "Clinical Oncological Dispensary"
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Saint Petersburg, Rosja, 191025
- LLC "Medicina Severnoy Stolitsy"
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Saint Petersburg, Rosja, 192007
- LLC "Severo-Zapadny Medical Center"
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Samara, Rosja, 443011
- Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"
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Ufa, Rosja, 450054
- SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
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Vologda, Rosja, 160002
- Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
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Vologda, Rosja, 160022
- Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
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Yaroslavl, Rosja, 150054
- State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
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Kaluga Oblast
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Obninsk, Kaluga Oblast, Rosja, 249036
- MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia
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Sankt-Peterburg
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Pushkin, Sankt-Peterburg, Rosja, 196603
- Private Medical Institution "Euromedservice"
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Stavropol Kray
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Pyatigorsk, Stavropol Kray, Rosja, 357502
- Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35233
- University of Alabama at Birmingham
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Birmingham, Alabama, Stany Zjednoczone, 35249
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Stany Zjednoczone, 85704
- Arizona Institute of Urology, PLLC
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California
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Beverly Hills, California, Stany Zjednoczone, 90211
- Beverly Hills Cancer Center
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Glendale, California, Stany Zjednoczone, 91206
- Adventist Health Glendale
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Long Beach, California, Stany Zjednoczone, 90822
- VA Long Beach Healthcare System
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06510
- Yale-New Haven Hospital
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District of Columbia
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Washington D.C., District of Columbia, Stany Zjednoczone, 20007
- MedStar Georgetown University Hospital
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Washington D.C., District of Columbia, Stany Zjednoczone, 20010
- Washington Cancer Institute at MedStar Washington Hospital Center
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Florida
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Orlando, Florida, Stany Zjednoczone, 32804
- Investigational Drug Services, Advent Health Orlando
-
Orlando, Florida, Stany Zjednoczone, 32804
- AdventHealth Medical Group Hematology and Oncology
-
-
Georgia
-
Austell, Georgia, Stany Zjednoczone, 30106
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
-
Austell, Georgia, Stany Zjednoczone, 30106
- Wellstar Cobb Hospital
-
Carrollton, Georgia, Stany Zjednoczone, 30117
- Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
-
Carrollton, Georgia, Stany Zjednoczone, 30117
- West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
-
Cartersville, Georgia, Stany Zjednoczone, 30121
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
-
Douglasville, Georgia, Stany Zjednoczone, 30134
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
-
Marietta, Georgia, Stany Zjednoczone, 30060
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
-
-
Illinois
-
Lake Barrington, Illinois, Stany Zjednoczone, 60010
- Comprehensive Urologic Care, SC
-
Normal, Illinois, Stany Zjednoczone, 61761
- Mid-Illinois Hematology & Oncology Associates, Ltd
-
-
Michigan
-
Detroit, Michigan, Stany Zjednoczone, 48202
- Henry Ford Health System
-
Detroit, Michigan, Stany Zjednoczone, 48202
- Henry Ford Medical Center - New Center One
-
Farmington Hills, Michigan, Stany Zjednoczone, 48334
- Revive Research Institute, Inc.
-
-
Missouri
-
St Louis, Missouri, Stany Zjednoczone, 63141
- David C. Pratt Cancer Center
-
-
New Jersey
-
Belleville, New Jersey, Stany Zjednoczone, 07109
- New Jersey Cancer Care, P.A.
-
-
New York
-
Poughkeepsie, New York, Stany Zjednoczone, 12603
- Premier Medical Group of the Hudson Valley PC
-
-
Oregon
-
Portland, Oregon, Stany Zjednoczone, 97213
- Providence Cancer Institute Franz Clinic
-
Portland, Oregon, Stany Zjednoczone, 97213
- Providence Portland Medical Center
-
-
Pennsylvania
-
Lancaster, Pennsylvania, Stany Zjednoczone, 17604
- Keystone Urology Specialists
-
-
South Carolina
-
Myrtle Beach, South Carolina, Stany Zjednoczone, 29572
- Carolina Urologic Research Center, LLC
-
-
Tennessee
-
Bristol, Tennessee, Stany Zjednoczone, 37620
- Bristol Regional Medical Center
-
Kingsport, Tennessee, Stany Zjednoczone, 37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport, Tennessee, Stany Zjednoczone, 37660
- Indian Path Community Hospital
-
Kingsport, Tennessee, Stany Zjednoczone, 37660
- Holston Valley Hospital and Medical Center
-
-
Texas
-
Houston, Texas, Stany Zjednoczone, 77005
- Kelsey Research Foundation
-
Houston, Texas, Stany Zjednoczone, 77025
- Kelsey-Seybold Clinic
-
Houston, Texas, Stany Zjednoczone, 77027
- Houston Metro Urology
-
Houston, Texas, Stany Zjednoczone, 77008
- Oncology Consultants, P.A.
-
Houston, Texas, Stany Zjednoczone, 77030
- Oncology Consultants P.A.
-
Houston, Texas, Stany Zjednoczone, 77014
- Kelsey-Seybold Clinic
-
Houston, Texas, Stany Zjednoczone, 77055
- Kelsey-Seybold Clinic
-
Houston, Texas, Stany Zjednoczone, 77024
- oncology Consultants, P.A.
-
San Antonio, Texas, Stany Zjednoczone, 78229
- Urology San Antonio
-
Webster, Texas, Stany Zjednoczone, 77598
- Texas Oncology-Deke Slayton Cancer Center
-
-
Utah
-
Salt Lake City, Utah, Stany Zjednoczone, 84112
- Huntsman Cancer Institute - University of Utah
-
-
-
-
-
Banská Bystrica, Słowacja, 975 17
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
-
Bratislava, Słowacja, 833 10
- Narodny onkologicky ustav
-
Košice, Słowacja, 041 91
- Vychodoslovensky onkologicky ustav, a.s.
-
Nitra, Słowacja, 949 01
- UROEXAM, spol. s r.o.
-
Poprad, Słowacja, 058 01
- POKO Poprad s.r.o.
-
Prešov, Słowacja, 08001
- MILAB s.r.o.
-
Trenčín, Słowacja, 911 01
- Privatna urologicka ambulancia, s.r.o.
-
-
-
-
-
Kaohsiung City, Tajwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Taichung, Tajwan, 40705
- Taichung Veterans General Hospital
-
Tainan, Tajwan, 704
- National Cheng Kung University Hospital
-
Taipei, Tajwan, 10002
- National Taiwan University Hospital
-
Taipei, Tajwan, 11217
- Taipei Veterans General Hospital
-
Taoyuan City, Tajwan, 333
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Adana, Turcja (Türkiye), 01415
- Adana City Training and Research Hospital
-
Ankara, Turcja (Türkiye), 06620
- Ankara University Faculty of Medicine
-
Ankara, Turcja (Türkiye), 06800
- Ankara City Hospital
-
Edirne, Turcja (Türkiye), 22030
- Trakya University Medical Faculty
-
Istanbul, Turcja (Türkiye), 34098
- Istanbul University, Cerrahpasa Faculty of Medicine
-
Istanbul, Turcja (Türkiye), 34722
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Malatya, Turcja (Türkiye), 44280
- Inonu University, Faculty of Medicine
-
-
-
-
-
Dnipro, Ukraina, 49102
- Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
-
Dnipro, Ukraina, 49005
- Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)
-
Kharkiv, Ukraina, 61070
- Communal Non-Profit Enterprise "Regional Center of Oncology"
-
Kharkiv, Ukraina, 61037
- Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of
-
Lviv, Ukraina, 79031
- Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre
-
-
Dnipropetrovsk Oblast
-
Kryviy Rih, Dnipropetrovsk Oblast, Ukraina, 50048
- MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
-
-
Kyiv Oblast
-
Pliuty Village, Kyiv Oblast, Ukraina, 08720
- Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"
-
-
Kyivska Oblast
-
Khodosovka, Kyivska Oblast, Ukraina, 08173
- Asklepion Medical Center
-
Kyiv, Kyivska Oblast, Ukraina, 03022
- National Cancer Institute
-
-
-
-
-
Budapest, Węgry, 1122
- Országos Onkológiai Intézet
-
Budapest, Węgry, 1204
- Jahn Ferenc Del-pesti Korhaz es Rendelointezet
-
Budapest, Węgry, 1145
- Uzsoki Utcai Korhaz
-
Budapest, Węgry, 1076
- Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet
-
-
-
-
-
Arezzo, Włochy, 52100
- Ospedale San Donato
-
Arezzo, Włochy, 52100
- Azienda Unita Sanitaria Locale Toscana Sud-Est
-
Bari, Włochy, 70124
- IRCCS Istituto Tumori "Giovanni Paolo II" di Bari
-
Bergamo, Włochy, 24127
- ASST Papa Giovanni XXIII
-
Brescia, Włochy, 25123
- ASST degli Spedali Civili de Brescia
-
Orbassano, Włochy, 10043
- Azienda Ospedaliera Universitaria San Luigi Gonzaga- Uinta di Oncologia Polmonare
-
Verona, Włochy, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
-
-
BO
-
Bologna, BO, Włochy, 40138
- Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
-
-
CR
-
Cremona, CR, Włochy, 26100
- ASST Cremona
-
-
FC
-
Meldola, FC, Włochy, 47014
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST)
-
-
FG
-
San Giovanni Rotondo, FG, Włochy, 71013
- Fondazione Casa Sollievo della Sofferenza
-
-
Naples
-
Naples, Naples, Włochy, 80131
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
-
-
PN
-
Aviano, PN, Włochy, 33081
- Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
-
-
TN
-
Trento, TN, Włochy, 38122
- Ospedale Santa Chiara
-
-
Trentino-Alto Adige
-
Trento, Trentino-Alto Adige, Włochy, 38123
- Azienda Provinciale per i Servizi Sanitari, della Provincia Autonoma di Trento
-
-
-
-
-
Birmingham, Zjednoczone Królestwo, B9 5SS
- University Hospitals Birmingham NHS Foundation Trust
-
Glasgow, Zjednoczone Królestwo, G12 0YN
- NHS Greater Glasgow and Clyde
-
London, Zjednoczone Królestwo, SW3 6JJ
- The Royal Marsden NHS Foundation Trust
-
London, Zjednoczone Królestwo, W6 8RF
- Imperial College Healthcare NHS Trust
-
Manchester, Zjednoczone Królestwo, M20 4BX
- The Christie NHS Foundation Trust
-
-
Devon
-
Exeter, Devon, Zjednoczone Królestwo, EX2 5DW
- Royal Devon and Exeter NHS Foundation Trust
-
-
KENT
-
Maidstone, KENT, Zjednoczone Królestwo, ME16 9QQ
- Maidstone and Tunbridge Wells NHS Trust
-
-
Lancashire
-
Preston, Lancashire, Zjednoczone Królestwo, PR2 9HT
- Lancashire Teaching Hospitals NHS Foundation Trust
-
-
Midlothian
-
Edinburgh, Midlothian, Zjednoczone Królestwo, EH4 2XU
- NHS Lothian
-
-
Scotland
-
Glasgow, Scotland, Zjednoczone Królestwo, G12 0XH
- Greater Glasgow Health Board J B Russell House, Gartnavel Royal Hospital
-
-
South Yorkshire
-
Sheffield, South Yorkshire, Zjednoczone Królestwo, S10 2SJ
- Sheffield Teaching Hospitals NHS Foundation Trust
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
-
Male participants at least 18 years of age at screening (20 years for Japan, 19 years for Republic of Korea).
-
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell or signet cell features. If the participant does not have a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis and may also be used to support biomarker analysis.
-
Confirmation of DDR gene mutation status by prospective or historical analysis (with sponsor pre-approval) of blood (liquid biopsy) and/or de novo or archival tumor tissue using FoundationOne Liquid CDx or FoundationOne CDx.
-
Willing to provide tumor tissue when available (de novo or archived) for retrospective molecular profiling analysis, if not already provided as part of inclusion criterion 3.
-
Unless prohibited by local regulations or ethics committee decision, consent to a saliva sample collection for retrospective sequencing of the same DDR genes tested on tumor tissue and blood (liquid biopsy), or a subset thereof, and to serve as a germline control in identifying tumor mutations.
-
Ongoing ADT with a GnRH agonist or antagonist for participants who have not undergone bilateral orchiectomy must be initiated before randomization and must continue throughout the study.
-
Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on CT or MRI scan (for soft tissue). Participants whose disease spread is limited to regional pelvic lymph nodes are not eligible. Note: a finding of superscan at baseline is exclusionary.
-
Prior treatment of mCSPC with docetaxel is not permitted.
-
Treatment with estrogens, cyproterone acetate, or first-generation anti-androgens is allowed until randomization.
-
Other prior therapy allowed for mCSPC; ≤3 months of ADT (chemical or surgical) with or without approved NHT in mCSPC (ie, abiraterone + prednisone, apalutamide, or enzalutamide), if required prior to randomization, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.
-
Participant may have received palliative radiation or surgery for symptomatic control secondary to prostate cancer, which should have been completed at least 2 weeks prior to randomization. NOTE: Radical prostatectomy or definitive radiotherapy to the primary tumor for metastatic castration-sensitive prostate cancer with curative intent is not permitted.
-
ECOG performance status 0 or 1.
-
Adequate organ function within 28 days before the first study treatment on Day 1, defined by the following:
- ANC ≥1500/µL, platelets ≥100,000/µL, or hemoglobin ≥9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology laboratory tests at screening).
- Total serum bilirubin <1.5 × ULN (<3 × ULN for participants with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).
- AST or ALT <2.5 × ULN (<5 × ULN if liver function abnormalities are due to hepatic metastasis).
- Albumin >2.8 g/dL.
- eGFR ≥30 mL/min/1.73 m2 by the MDRD equation.
-
Sexually active participants that in the opinion of the investigator are capable of ejaculating, must agree to use a condom when having sex with a partner (female or male) from the time of the first dose of study treatment through 4 months after last dose of study treatment (or, if talazoparib/placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide). Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment (or, if talazoparib / placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide) when having sex.
-
Must agree not to donate sperm from the first dose of study treatment to 4 months after the last dose of study treatment (or, if talazoparib/placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide).
-
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including being able to manage electronic diaries. The PRO assessments are not required to be completed if a patient does not understand the language(s) available for a specific questionnaire and/or cannot complete the specific questionnaire independently.
-
Capable of giving signed informed consent.
-
For France only: Participants affiliated with the social security system or beneficiaries of an equivalent system.
Exclusion Criteria:
-
Other acute or chronic medical (concurrent disease, infection, including chronic stable HIV, HBV, or HCV infection, or co-morbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that interferes with a participant's ability to participate in the study, may increase the risk of associated with study participation or study treatment administration, or may interfere with the interpretation of study results, and, in the investigator's judgment, make the participant inappropriate for entry into the study. HIV/HBV/HCV testing is not required unless mandated by local health authority.
-
History of seizure or any condition (as assessed by investigator) that may predispose to seizure (eg, prior cortical stroke, significant brain trauma), including any history of loss of consciousness or transient ischemic attack within 12 months of randomization.
-
Major surgery (as defined by the investigator) within 4 weeks before randomization.
-
Known or suspected brain metastasis or active leptomeningeal disease.
-
Symptomatic or impending spinal cord compression or cauda equina syndrome.
-
Any history of MDS, AML, or prior malignancy except for the following:
- Carcinoma in situ or non-melanoma skin cancer.
- A cancer diagnosed and treated ≥3 years before randomization with no subsequent evidence of recurrence.
- American Joint Committee on Cancer Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence in the opinion of the investigator and the sponsor.
-
In the opinion of the investigator, any clinically significant gastrointestinal disorder affecting absorption.
-
Clinically significant cardiovascular disease, including any of the following:
- Myocardial infarction or symptomatic cardiac ischemia within 6 months before randomization.
- Congestive heart failure New York Heart Association class III or IV.
- History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes) within 1 year before screening.
- History of Mobitz II second degree or third-degree heart block unless a permanent pacemaker is in place.
- Hypotension as indicated by systolic blood pressure <86 mm Hg at screening.
- Bradycardia as indicated by a heart rate of <45 beats per minute on the screening electrocardiogram.
- Uncontrolled hypertension as indicated by systolic blood pressure >170 mm Hg or diastolic blood pressure >105 mm Hg at screening. However, participants can be rescreened after adequate control of blood pressure is achieved.
-
Active COVID-19 infection detected by viral test or based on clinical diagnosis (as assessed by investigator). Asymptomatic participants with no active COVID-19 infection detected but positive antibody tests, indicating past infection are allowed.
-
Prior ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was less than 12 months prior to randomization and the total duration of ADT exceeded 36 months.
-
Participant received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to randomization, intended for the treatment of prostate cancer.
-
Any previous treatment with DNA-damaging cytotoxic chemotherapy (ie, platinum based therapy) within 5 years prior to randomization, except for indications other than prostate cancer.
-
Prior treatment with a PARPi, or known or possible hypersensitivity to enzalutamide, any of enzalutamide capsule excipients or to any talazoparib/placebo capsule excipients.
-
Prior treatment in any setting with NHT, except as described in Inclusion Criterion #10.
-
Current use of potent P-gp inhibitors within 7 days prior to randomization.
-
Treatment with any investigational study intervention within 4 weeks before randomization. Exception: COVID-19 vaccines authorized under an emergency use authorization (or equivalent) can be administered without a washout period.
-
Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF interval >470 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >470 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 470 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
-
Investigator site staff or Sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
-
For France only: Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care, as well as adults subject to a legal protection measure (guardianship, curatorship, and safeguard of justice) covered by Articles 1121-6 to 1121-8 of the Public Health Code.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Arm 1
Talazoparib plus enzalutamide |
experimental arm
Inne nazwy:
|
|
Aktywny komparator: Arm 2
Placebo plus enzalutamide |
Active comparator arm
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
radiological Progression-Free Survival
Ramy czasowe: randomization up to 3 years
|
time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first |
randomization up to 3 years
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Overall Survival
Ramy czasowe: randomization up to 4 years
|
time from randomization to death from any cause |
randomization up to 4 years
|
|
Objective response in measurable soft tissue disease
Ramy czasowe: randomization up to 3 years
|
proportion of patients with measurable soft tissue disease at baseline with objective response per RECIST 1.1 |
randomization up to 3 years
|
|
Duration of response in measurable soft tissue disease
Ramy czasowe: randomization up to 3 years
|
duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1 |
randomization up to 3 years
|
|
Prostate Specific Antigen (PSA) response
Ramy czasowe: randomization up to 3 years
|
proportion of patients with PSA response grater than or equal to 50% |
randomization up to 3 years
|
|
Time to PSA progression
Ramy czasowe: randomization up to 3 years
|
time from baseline to PSA progression |
randomization up to 3 years
|
|
Time to initiation of antineoplastic therapy
Ramy czasowe: randomization up to 3 years
|
Time from randomization to initiation of antineoplastic therapy |
randomization up to 3 years
|
|
Time to first symptomatic skeletal event
Ramy czasowe: randomization up to 3 years
|
time from randomization to first symptomatic skeletal event (symptomatic fractures, spinal cord compression, surgery or radiation to the bone whichever is first) |
randomization up to 3 years
|
|
Opiate use for prostate cancer pain
Ramy czasowe: randomization up to 3 years
|
time from randomization to opiate use for prostate cancer pain |
randomization up to 3 years
|
|
Incidence of adverse events
Ramy czasowe: randomization up to 3 years
|
AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03) |
randomization up to 3 years
|
|
Pharmacokinetic assessment of talazoparib
Ramy czasowe: Weeks 5, 9, 13, and 17
|
plasma concentrations of talazoparib |
Weeks 5, 9, 13, and 17
|
|
Pharmacokinetic assessment of enzalutamide and its metabolite
Ramy czasowe: Weeks 5, 9, 13, and 17
|
plasma concentrations of enzalutamide and its metabolite |
Weeks 5, 9, 13, and 17
|
|
Relationship between ctDNA burden and outcome
Ramy czasowe: randomization up to 3 years
|
ctDNA burden at baseline and on study |
randomization up to 3 years
|
|
Patient-reported outcomes in pain symptoms - change from baseline
Ramy czasowe: randomization up to 3 years
|
change from baseline in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF) |
randomization up to 3 years
|
|
Patient-reported outcomes in pain symptoms - time to deterioration
Ramy czasowe: randomization up to 3 years
|
time to deterioration in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF) |
randomization up to 3 years
|
|
Patient-reported outcomes in cancer specific general health status - change from baseline
Ramy czasowe: randomization up to 3 years
|
change from baseline in participant-reported general health status per EQ-5D-5L |
randomization up to 3 years
|
|
Patient-reported outcomes in cancer specific global health status/QoL - change from baseline
Ramy czasowe: randomization up to 3 years
|
change from baseline in patient-reported Global health status/QoL per EORTC QLQ-C30 |
randomization up to 3 years
|
|
Patient-reported outcomes in cancer specific global health status/QoL - time to definitive deterioration
Ramy czasowe: randomization up to 3 years
|
time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30 |
randomization up to 3 years
|
|
Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration
Ramy czasowe: randomization up to 3 years
|
time to definitive deterioration in disease specific urinary symptoms per EORTC QLQ-PR25 |
randomization up to 3 years
|
|
Patient-reported outcome: cancer specific functioning, and symptoms - change from baseline
Ramy czasowe: randomization up to 3 years
|
change from baseline in PGI-S |
randomization up to 3 years
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: Pfizer CT.gov Call Center, Pfizer
Publikacje i pomocne linki
Publikacje ogólne
- Agarwal N, Saad F, Azad AA, Mateo J, Matsubara N, Shore ND, Chakrabarti J, Chen HC, Lanzalone S, Niyazov A, Fizazi K. TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer. Future Oncol. 2024 Mar;20(9):493-505. doi: 10.2217/fon-2023-0526. Epub 2023 Oct 26.
- Agarwal N, Matsubara N, Azad AA, Saad F, Mateo J, Jiang S, Ye D, Voog E, Shore ND, Cil T, Vulsteke C, Chung HJ, Zschabitz S, Laird AD, Zhang X, Nandoskar P, Chetcuti SF, Wang F, Fizazi K. PARP and Androgen-Signaling Inhibition plus ADT in Metastatic Prostate Cancer. N Engl J Med. 2026 Jul 30;395(5):427-439. doi: 10.1056/NEJMoa2604126. Epub 2026 May 30.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
- rak prostaty
- enzalutamid
- NRD
- wrażliwe na kastrację
- Inhibitor PARP
- wrażliwa na hormony
- hormonowrażliwy rak gruczołu krokowego z przerzutami
- Zaawansowany rak prostaty
- Rak gruczołu krokowego wrażliwy na kastrację z przerzutami
- mCSPC
- przerzutowy rak prostaty
- Odpowiedź na uszkodzenie DNA
- Naprawa uszkodzeń DNA
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby narządów płciowych
- Nowotwory narządów płciowych, mężczyzna
- Nowotwory układu moczowo-płciowego
- Nowotwory według lokalizacji
- Nowotwory
- Choroby narządów płciowych, mężczyzna
- Choroby prostaty
- Choroby układu moczowo-płciowego u mężczyzn
- Nowotwory prostaty
- enzalutamid
- Talazoparib
Inne numery identyfikacyjne badania
- C3441052
- TALAPRO-3 (Inny identyfikator: Alias Study Number)
- 2024-510809-28-00 (Identyfikator rejestru: CTIS (EU))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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