Studie talazoparibu s enzalutamidem u mužů s mutovaným genem DDR mCSPC
TALAPRO-3: FÁZE 3, RANDOMIZOVANÁ, DVOJLE SLEPÁ, STUDIE TALAZOPARIB S ENZALUTAMIDEM VERSUS PLACEBO S ENZALUTAMIDEM U MUŽŮ S METASTATICKOU KASTRACÍ CITLIVOU RAKOVINOU PROSTATY CITLIVÝM GENEM DDR
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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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 studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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CABA, Argentina, C1426ANZ
- Instituto Médico Especializado Alexander Fleming
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Caba, Argentina, C1426AGE
- Centro Oncologico Korben
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Córdoba, Argentina, X5008HHW
- Centro Medico Privado CEMAIC
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Buenos Aires
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Berazategui, Buenos Aires, Argentina, B1884BBF
- COIBA
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Pergamino, Buenos Aires, Argentina, B2700CPM
- Centro de Investigacion Pergamino SA - Clinica Pergamino SA
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Río Negro Province
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Viedma, Río Negro Province, Argentina, R8500ACE
- Centro de Investigaciones Clínicas - Clínica Viedma
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000IAK
- Centro Medico San Roque
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New South Wales
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Camperdown, New South Wales, Austrálie, 2050
- Chris O'Brien Lifehouse
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Wollongong, New South Wales, Austrálie, 2500
- Cancer Care Wollongong Pty Limited
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Queensland
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Brisbane, Queensland, Austrálie, 4120
- Gallipoli Medical Research Foundation, Greenslopes Private Hospital
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Southport, Queensland, Austrálie, 4215
- Gold Coast University Hospital
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South Australia
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Woodville South, South Australia, Austrálie, 5011
- The Queen Elizabeth Hospital
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Victoria
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East Melbourne, Victoria, Austrálie, 3002
- Epworth Freemasons-Epworth HealthCare
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Malvern, Victoria, Austrálie, 3144
- Cabrini Hospital
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Richmond, Victoria, Austrálie, 3121
- Epworth Foundation Trading as Epworth HealthCare
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St Albans, Victoria, Austrálie, 3021
- Western Health, Sunshine Hospital
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Aalst, Belgie, 9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Anderlecht, Belgie, 1070
- Institut Jules Bordet
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Brussels, Belgie, 1200
- Cliniques universitaires Saint-Luc
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Brussels, Belgie, 1000
- Institut Jules Bordet
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Ghent, Belgie, 9000
- AZ (Algemeen Ziekenhuis) Maria Middelares
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Ghent, Belgie, 9000
- AZ (Algemeen Ziekenhuis) Sint-Lucas
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Kortrijk, Belgie, 8500
- AZ (Algemeen Ziekenhuis) Groeninge
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Liège, Belgie, 4000
- CHU de Liege
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Merksem, Belgie, 2170
- ZNA Jan Palfijn
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Panagyurishte, Bulharsko, 4500
- Multiprofile Hospital for Active Treatment - Uni Hospital OOD
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Plovdiv, Bulharsko, 4000
- Complex Oncology Center - Plovdiv EOOD
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Plovdiv, Bulharsko, 4000
- Independent medical-diagnostic laboratory "Medisken" EOOD
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Plovdiv, Bulharsko, 4000
- Complex Oncology Center- Plovdiv EOOD
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Shumen, Bulharsko, 9700
- Complex Oncology Center - Shumen EOOD
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Sofia, Bulharsko, 1407
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
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Sofia, Bulharsko
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
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Stara Zagora, Bulharsko, 6003
- Complex Oncology Center - Stara Zagora Ltd.
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Stara Zagora, Bulharsko, 6003
- MRI SMDLOD "Mediscan" Ltd
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Stara Zagora, Bulharsko, 6003
- UMHAT "Prof. Dr. Stoyan Kirkovich"
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Helsinki, Finsko, 00029
- Helsinki University Hospital
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Helsinki, Finsko, 00180
- Docrates Cancer Center
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Helsinki, Finsko, 00280
- Clinical Research Institute Helsinki University Central Hospital Ltd
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Kuopio, Finsko, 70210
- Kuopio University Hospital
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Tampere, Finsko, 33520
- Tampere University Hospital
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Turku, Finsko, 20520
- Turku University Hospital
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Angers, Francie, 49933
- Centre Hospitalier Universitaire d'Angers
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Bayonne, Francie, 64100
- Clinique Belharra
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Lille, Francie, 59000
- Hopital Prive le Bois
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Lyon, Francie, 69373
- Centre Leon Berard
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Paris, Francie, 75018
- Hopital Bichat - Claude Bernard
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Paris, Francie, 75877
- Hopital Bichat - Claude Bernard
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Pierre-Bénite, Francie, 69310
- Hopital Lyon Sud
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Quint-Fonsegrives, Francie, 31130
- Clinique La Croix du Sud - Ramsay Sante
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Reims, Francie, 51726
- Institut Jean Godinot
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Saint-Grégoire, Francie, 35760
- CHP Saint-Grégoire
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Strasbourg, Francie, 67200
- Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)
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Vandœuvre-lès-Nancy, Francie, 54519
- Institut de cancerologie de Lorraine
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Villejuif, Francie, 94805
- Gustave Roussy
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Brittany Region
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Brest, Brittany Region, Francie, 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, Francie, 72000
- Clinique Victor Hugo Le Mans
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Île-de-France Region
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Créteil, Île-de-France Region, Francie, 94010
- Hopital Henri Mondor
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The Hague, Holandsko, 2545 AA
- Stichting HagaZiekenhuis
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Utrecht
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Amersfoort, Utrecht, Holandsko, 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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Arezzo, Itálie, 52100
- Ospedale San Donato
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Arezzo, Itálie, 52100
- Azienda Unita Sanitaria Locale Toscana Sud-Est
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Bari, Itálie, 70124
- IRCCS Istituto Tumori "Giovanni Paolo II" di Bari
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Bergamo, Itálie, 24127
- ASST Papa Giovanni XXIII
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Brescia, Itálie, 25123
- ASST degli Spedali Civili de Brescia
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Orbassano, Itálie, 10043
- Azienda Ospedaliera Universitaria San Luigi Gonzaga- Uinta di Oncologia Polmonare
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Verona, Itálie, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
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BO
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Bologna, BO, Itálie, 40138
- Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
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CR
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Cremona, CR, Itálie, 26100
- ASST Cremona
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FC
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Meldola, FC, Itálie, 47014
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST)
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FG
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San Giovanni Rotondo, FG, Itálie, 71013
- Fondazione Casa Sollievo della Sofferenza
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Naples
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Naples, Naples, Itálie, 80131
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
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PN
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Aviano, PN, Itálie, 33081
- Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
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TN
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Trento, TN, Itálie, 38122
- Ospedale Santa Chiara
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Trentino-Alto Adige
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Trento, Trentino-Alto Adige, Itálie, 38123
- Azienda Provinciale per i Servizi Sanitari, della Provincia Autonoma di Trento
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Kagoshima, Japonsko, 890-8520
- Kagoshima University Hospital
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Kumamoto, Japonsko, 860-0008
- National Hospital Organization Kumamoto Medical Center
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Tokushima, Japonsko, 770-8503
- Tokushima University Hospital
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Yamagata, Japonsko, 990-9585
- Yamagata University Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japonsko, 466-8560
- Nagoya University Hospital
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Aomori
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Hirosaki, Aomori, Japonsko, 036-8563
- Hirosaki University School of Medicine & Hospital
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Chiba
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Chiba, Chiba, Japonsko, 2608717
- Chiba cancer center
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Kashiwa, Chiba, Japonsko, 277-8577
- National Cancer Center Hospital East
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Ehime
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Matsuyama, Ehime, Japonsko, 791-0280
- National Hospital Organization Shikoku Cancer Center
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Fukuoka
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Fukuoka, Fukuoka, Japonsko, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Hiroshima
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Kure, Hiroshima, Japonsko, 737-0023
- National Hospital Organization Kure Medical Center and Chugoku Cancer Center
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Hokkaido
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Sapporo, Hokkaido, Japonsko, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Sapporo, Hokkaido, Japonsko, 060-8648
- Hokkaido University Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japonsko, 920-8641
- Kanazawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japonsko, 232-0024
- Yokohama City University Medical Center
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Yokosuka, Kanagawa, Japonsko, 238-8558
- Yokosukakyosai
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Osaka
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Osaka, Osaka, Japonsko, 5418567
- Osaka International Cancer Institute
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Sakai, Osaka, Japonsko, 590-0197
- Kindai University Hospital
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Suita, Osaka, Japonsko, 565-0871
- The University of Osaka Hospital
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Shizuoka
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Hamamatsu, Shizuoka, Japonsko, 431-3192
- Hamamatsu University Hospital
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Tokyo
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Meguro-Ku, Tokyo, Japonsko, 152-8902
- National Hospital Organization Tokyo Medical Center
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Shinjuku-ku, Tokyo, Japonsko, 160-8582
- Keio university hospital
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Gauteng
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Johannesburg, Gauteng, Jižní Afrika, 2193
- Charlotte Maxeke Johannesburg Academic Hospital
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Johannesburg, Gauteng, Jižní Afrika, 2193
- 15 Eton Road
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Johannesburg, Gauteng, Jižní Afrika, 2193
- WCR Office
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Johannesburg, Gauteng, Jižní Afrika, 2196
- Sandton Oncology Medical Group (Pty) Ltd
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Parktown, Gauteng, Jižní Afrika, 2193
- Wits Clinical Research
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Pretoria, Gauteng, Jižní Afrika, 0002
- Clinical Research Unit, University of Pretoria
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Daegu, Jižní Korea, 41404
- Kyungpook National University Chilgok Hospital
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Seoul, Jižní Korea, 03080
- Seoul National University Hospital
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Seoul, Jižní Korea, 05505
- Asan Medical Center
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Seoul, Jižní Korea, 06351
- Samsung Medical Center
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Seoul, Jižní Korea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Jižní Korea, 06591
- The Catholic Univ. of Korea Seoul St. Mary's Hospital
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Seoul, Jižní Korea, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Jižní Korea, 07985
- Ewha Womans University Mokdong Hospital
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Jižní Korea, 10408
- National Cancer Center
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Jeollanam-do
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Hwasun-gun, Jeollanam-do, Jižní Korea, 58128
- Chonnam National University Hwasun Hospital
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Kyǒnggi-do
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Seongnam, Kyǒnggi-do, Jižní Korea, 13620
- Seoul National University Bundang 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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Budapest, Maďarsko, 1122
- Országos Onkológiai Intézet
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Budapest, Maďarsko, 1204
- Jahn Ferenc Del-pesti Korhaz es Rendelointezet
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Budapest, Maďarsko, 1145
- Uzsoki Utcai Korhaz
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Budapest, Maďarsko, 1076
- Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet
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Oaxaca City, Mexiko, 68020
- Centro de Investigacion Clinica de Oaxaca
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Veracruz, Mexiko, 91851
- Instituto Veracruzano en Investigación Clínica S.C.
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Guanajuato
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León, Guanajuato, Mexiko, 37178
- Preparaciones Oncológicas S.C.
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Nuevo León
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Monterrey, Nuevo León, Mexiko, 64460
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
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Monterrey, Nuevo León, Mexiko, 64040
- Axis Heilsa S. de R.L. de C.V.
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Oaxaca
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Oaxaca City, Oaxaca, Mexiko, 68000
- Oaxaca Site Management Organization
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State of Mexico
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Naucalpan, State of Mexico, Mexiko, 53100
- Oncologia Integral Satelite SA de CV
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Gjøvik, Norsko, 2819
- Sykehuset Innlandet Gjoevik
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Berlin, Německo, 10117
- Charite Universitaetsmedizin Berlin - Campus Mitte
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Duisburg, Německo, 47169
- Urologicum Duisburg
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Frankfurt, Německo, 60590
- Universitaetsklinikum Frankfurt
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Göttingen, Německo, 37075
- Institut fuer Diagnostische und Interventionelle Radiologie
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Göttingen, Německo, 37075
- Klinik fuer Nuklearmedizin
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Heidelberg, Německo, 69120
- Universitaetsklinik Heidelberg
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Leipzig, Německo, 04105
- Uro-/Onkologisches Zentrum
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Nürtingen, Německo, 72622
- Studienpraxis Urologie
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Tübingen, Německo, 72076
- Universitaetsklinikum Tuebingen
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Lower Saxony
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Göttingen, Lower Saxony, Německo, 37075
- Universitaetsmedizin Goettingen
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North Rhine-Westphalia
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Wesel, North Rhine-Westphalia, Německo, 46483
- Urologische Gemeinschaftspraxis Wesel
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Thuringia
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Jena, Thuringia, Německo, 07747
- Universitätsklinikum Jena
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Chelyabinsk, Rusko, 454048
- Evimed Llc
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Chelyabinsk, Rusko, 454087
- SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
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Ivanovo, Rusko, 153040
- Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")
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Moscow, Rusko, 117997
- Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of the
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Moscow, Rusko, 121205
- Branch of the Limited Liability Company "Hadassah Medical Ltd."
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Moscow, Rusko, 121359
- Federal State Budgetary Institution "Central Clinical Hospital with ambulance"
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Omsk, Rusko, 644013
- BHI of Omsk region "Clinical Oncological Dispensary"
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Saint Petersburg, Rusko, 191025
- LLC "Medicina Severnoy Stolitsy"
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Saint Petersburg, Rusko, 192007
- LLC "Severo-Zapadny Medical Center"
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Samara, Rusko, 443011
- Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"
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Ufa, Rusko, 450054
- SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
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Vologda, Rusko, 160002
- Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
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Vologda, Rusko, 160022
- Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
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Yaroslavl, Rusko, 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, Rusko, 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, Rusko, 196603
- Private Medical Institution "Euromedservice"
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Stavropol Kray
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Pyatigorsk, Stavropol Kray, Rusko, 357502
- Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")
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Banská Bystrica, Slovensko, 975 17
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
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Bratislava, Slovensko, 833 10
- Narodny onkologicky ustav
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Košice, Slovensko, 041 91
- Vychodoslovensky onkologicky ustav, a.s.
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Nitra, Slovensko, 949 01
- UROEXAM, spol. s r.o.
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Poprad, Slovensko, 058 01
- POKO Poprad s.r.o.
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Prešov, Slovensko, 08001
- MILAB s.r.o.
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Trenčín, Slovensko, 911 01
- Privatna urologicka ambulancia, s.r.o.
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Birmingham, Spojené království, B9 5SS
- University Hospitals Birmingham NHS Foundation Trust
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Glasgow, Spojené království, G12 0YN
- NHS Greater Glasgow and Clyde
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London, Spojené království, SW3 6JJ
- The Royal Marsden NHS Foundation Trust
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London, Spojené království, W6 8RF
- Imperial College Healthcare NHS Trust
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Manchester, Spojené království, M20 4BX
- The Christie NHS Foundation Trust
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Devon
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Exeter, Devon, Spojené království, EX2 5DW
- Royal Devon and Exeter NHS Foundation Trust
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KENT
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Maidstone, KENT, Spojené království, ME16 9QQ
- Maidstone and Tunbridge Wells NHS Trust
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Lancashire
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Preston, Lancashire, Spojené království, PR2 9HT
- Lancashire Teaching Hospitals NHS Foundation Trust
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Midlothian
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Edinburgh, Midlothian, Spojené království, EH4 2XU
- NHS Lothian
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Scotland
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Glasgow, Scotland, Spojené království, G12 0XH
- Greater Glasgow Health Board J B Russell House, Gartnavel Royal Hospital
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South Yorkshire
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Sheffield, South Yorkshire, Spojené království, S10 2SJ
- Sheffield Teaching Hospitals NHS Foundation Trust
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Alabama
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Birmingham, Alabama, Spojené státy, 35233
- University of Alabama at Birmingham
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Birmingham, Alabama, Spojené státy, 35249
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Spojené státy, 85704
- Arizona Institute of Urology, PLLC
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California
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Beverly Hills, California, Spojené státy, 90211
- Beverly Hills Cancer Center
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Glendale, California, Spojené státy, 91206
- Adventist Health Glendale
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Long Beach, California, Spojené státy, 90822
- VA Long Beach Healthcare System
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Connecticut
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New Haven, Connecticut, Spojené státy, 06510
- Yale-New Haven Hospital
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District of Columbia
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Washington D.C., District of Columbia, Spojené státy, 20007
- MedStar Georgetown University Hospital
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Washington D.C., District of Columbia, Spojené státy, 20010
- Washington Cancer Institute at MedStar Washington Hospital Center
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Florida
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Orlando, Florida, Spojené státy, 32804
- Investigational Drug Services, Advent Health Orlando
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Orlando, Florida, Spojené státy, 32804
- AdventHealth Medical Group Hematology and Oncology
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Georgia
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Austell, Georgia, Spojené státy, 30106
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
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Austell, Georgia, Spojené státy, 30106
- Wellstar Cobb Hospital
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Carrollton, Georgia, Spojené státy, 30117
- Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
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Carrollton, Georgia, Spojené státy, 30117
- West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
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Cartersville, Georgia, Spojené státy, 30121
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
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Douglasville, Georgia, Spojené státy, 30134
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
-
Marietta, Georgia, Spojené státy, 30060
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
-
-
Illinois
-
Lake Barrington, Illinois, Spojené státy, 60010
- Comprehensive Urologic Care, SC
-
Normal, Illinois, Spojené státy, 61761
- Mid-Illinois Hematology & Oncology Associates, Ltd
-
-
Michigan
-
Detroit, Michigan, Spojené státy, 48202
- Henry Ford Health System
-
Detroit, Michigan, Spojené státy, 48202
- Henry Ford Medical Center - New Center One
-
Farmington Hills, Michigan, Spojené státy, 48334
- Revive Research Institute, Inc.
-
-
Missouri
-
St Louis, Missouri, Spojené státy, 63141
- David C. Pratt Cancer Center
-
-
New Jersey
-
Belleville, New Jersey, Spojené státy, 07109
- New Jersey Cancer Care, P.A.
-
-
New York
-
Poughkeepsie, New York, Spojené státy, 12603
- Premier Medical Group of the Hudson Valley PC
-
-
Oregon
-
Portland, Oregon, Spojené státy, 97213
- Providence Cancer Institute Franz Clinic
-
Portland, Oregon, Spojené státy, 97213
- Providence Portland Medical Center
-
-
Pennsylvania
-
Lancaster, Pennsylvania, Spojené státy, 17604
- Keystone Urology Specialists
-
-
South Carolina
-
Myrtle Beach, South Carolina, Spojené státy, 29572
- Carolina Urologic Research Center, LLC
-
-
Tennessee
-
Bristol, Tennessee, Spojené státy, 37620
- Bristol Regional Medical Center
-
Kingsport, Tennessee, Spojené státy, 37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport, Tennessee, Spojené státy, 37660
- Indian Path Community Hospital
-
Kingsport, Tennessee, Spojené státy, 37660
- Holston Valley Hospital and Medical Center
-
-
Texas
-
Houston, Texas, Spojené státy, 77005
- Kelsey Research Foundation
-
Houston, Texas, Spojené státy, 77025
- Kelsey-Seybold Clinic
-
Houston, Texas, Spojené státy, 77027
- Houston Metro Urology
-
Houston, Texas, Spojené státy, 77008
- Oncology Consultants, P.A.
-
Houston, Texas, Spojené státy, 77030
- Oncology Consultants P.A.
-
Houston, Texas, Spojené státy, 77014
- Kelsey-Seybold Clinic
-
Houston, Texas, Spojené státy, 77055
- Kelsey-Seybold Clinic
-
Houston, Texas, Spojené státy, 77024
- oncology Consultants, P.A.
-
San Antonio, Texas, Spojené státy, 78229
- Urology San Antonio
-
Webster, Texas, Spojené státy, 77598
- Texas Oncology-Deke Slayton Cancer Center
-
-
Utah
-
Salt Lake City, Utah, Spojené státy, 84112
- Huntsman Cancer Institute - University of Utah
-
-
-
-
-
Kaohsiung City, Tchaj-wan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Taichung, Tchaj-wan, 40705
- Taichung Veterans General Hospital
-
Tainan, Tchaj-wan, 704
- National Cheng Kung University Hospital
-
Taipei, Tchaj-wan, 10002
- National Taiwan University Hospital
-
Taipei, Tchaj-wan, 11217
- Taipei Veterans General Hospital
-
Taoyuan City, Tchaj-wan, 333
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Adana, Turecko (Türkiye), 01415
- Adana City Training and Research Hospital
-
Ankara, Turecko (Türkiye), 06620
- Ankara University Faculty of Medicine
-
Ankara, Turecko (Türkiye), 06800
- Ankara City Hospital
-
Edirne, Turecko (Türkiye), 22030
- Trakya University Medical Faculty
-
Istanbul, Turecko (Türkiye), 34098
- Istanbul University, Cerrahpasa Faculty of Medicine
-
Istanbul, Turecko (Türkiye), 34722
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Malatya, Turecko (Türkiye), 44280
- Inonu University, Faculty of Medicine
-
-
-
-
-
Dnipro, Ukrajina, 49102
- Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
-
Dnipro, Ukrajina, 49005
- Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)
-
Kharkiv, Ukrajina, 61070
- Communal Non-Profit Enterprise "Regional Center of Oncology"
-
Kharkiv, Ukrajina, 61037
- Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of
-
Lviv, Ukrajina, 79031
- Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre
-
-
Dnipropetrovsk Oblast
-
Kryviy Rih, Dnipropetrovsk Oblast, Ukrajina, 50048
- MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
-
-
Kyiv Oblast
-
Pliuty Village, Kyiv Oblast, Ukrajina, 08720
- Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"
-
-
Kyivska Oblast
-
Khodosovka, Kyivska Oblast, Ukrajina, 08173
- Asklepion Medical Center
-
Kyiv, Kyivska Oblast, Ukrajina, 03022
- National Cancer Institute
-
-
-
-
-
Olomouc, Česko, 779 00
- Fakultni nemocnice Olomouc
-
Ostrava - Poruba, Česko, 708 52
- Fakultni nemocnice Ostrava
-
Prague, Česko, 100 34
- Fakultni nemocnice Kralovske Vinohrady
-
Prague, Česko, 150 00
- Fakultni Nemocnice Motol a Homolka
-
Praha 8- Liben, Česko, 180 81
- Fakultni nemocnice Bulovka
-
-
-
-
-
Chongqing, Čína, 400042
- The First Affiliated Hospital Chongqing Medical University
-
Guangzhou, Čína, 510120
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Anhui
-
Hefei, Anhui, Čína, 230022
- The First Affiliated Hospital of Anhui Medical University
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Čína, 100034
- Peking University First Hospital
-
-
Gansu
-
Lanzhou, Gansu, Čína, 730030
- Lanzhou university second hospital
-
-
Guangdong
-
Guangzhou, Guangdong, Čína, 510515
- Nanfang Hospital of Southern Medical University
-
Guangzhou, Guangdong, Čína, 510230
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Henan
-
Zhengzhou, Henan, Čína, 450003
- Henan Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, Čína, 430079
- Hubei Cancer Hospital
-
Wuhan, Hubei, Čína, 430022
- Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
-
Wuhan, Hubei, Čína, 430030
- Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
-
-
Hunan
-
Changsha, Hunan, Čína, 410013
- Hunan Cancer Hospital
-
Changsha, Hunan, Čína, 410013
- The Third Xiangya Hospital of Central South University
-
-
Jiangsu
-
Nanjing, Jiangsu, Čína, 210009
- Zhongda Hospital Southeast University
-
Nantong, Jiangsu, Čína, 226000
- Nantong Tumor Hospital
-
Suzhou, Jiangsu, Čína, 215004
- The Second Affiliated Hospital of Soochow University
-
-
Jiangxi
-
Nanchang, Jiangxi, Čína, 330029
- Jiangxi Provincial Cancer Hospital
-
-
Jilin
-
Changchun, Jilin, Čína, 130021
- The First hospital of Jilin University
-
-
Shaanxi
-
Xi'an, Shaanxi, Čína, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Čína, 200032
- Fudan University Cancer Hospital
-
-
Sichuan
-
Chengdu, Sichuan, Čína, 610041
- West China Hospital of Sichuan University
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Čína, 300211
- The Second Hospital of Tianjin Medical University
-
-
Zhejiang
-
Hangzhou, Zhejiang, Čína, 310014
- Zhejiang Provincial People's Hospital
-
Ningbo, Zhejiang, Čína, 315010
- The first affiliated hospital of Ningbo university
-
Wenzhou, Zhejiang, Čína, 325000
- The First Affiliated Hospital of Wenzhou Medical University
-
-
-
-
-
Barcelona, Španělsko, 08035
- Hospital Universitari Vall d'Hebron
-
Barcelona, Španělsko, 08036
- Hospital Clínic de Barcelona
-
Córdoba, Španělsko, 14004
- Hospital Universitario Reina Sofía
-
Madrid, Španělsko, 28040
- Hospital Clinico San Carlos
-
Madrid, Španělsko, 28033
- MD Anderson Cancer Center
-
Madrid, Španělsko, 28009
- Hospital Universitario Gregorio Marañón
-
Seville, Španělsko, 41009
- Hospital Universitario Virgen de la Macarena
-
Valencia, Španělsko, 46026
- Hospital Politecnic Universitari La Fe
-
-
Alicante
-
Elche, Alicante, Španělsko, 03203
- Hospital General Universitario de Elche
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Španělsko, 08908
- Institut Català d'Oncologia de l'Hospitalet
-
Manresa, Barcelona, Španělsko, 08243
- Althaia, Xarxa Assistencial Universitària de Manresa
-
-
Barcelona [barcelona]
-
Badalona, Barcelona [barcelona], Španělsko, 08916
- Hospital Germans Trias i Pujol
-
-
Galicia
-
Lugo, Galicia, Španělsko, 27003
- Hospital Universitario Lucus Augusti
-
-
Madrid, Comunidad de
-
Majadahonda, Madrid, Comunidad de, Španělsko, 28222
- Hospital Universitario Puerta de Hierro
-
-
Navarre
-
Pamplona, Navarre, Španělsko, 31008
- Complejo Hospitalario de Navarra
-
-
Principality of Asturias
-
Oviedo, Principality of Asturias, Španělsko, 33011
- Hospital Universitario Central de Asturias
-
-
Tarragona
-
Reus, Tarragona, Španělsko, 43204
- Hospital Universitari Sant Joan de Reus
-
-
Valenciana, Comunitat
-
Valencia, Valenciana, Comunitat, Španělsko, 46009
- Fundación Instituto Valenciano de Oncología
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: Arm 1
Talazoparib plus enzalutamide |
experimental arm
Ostatní jména:
|
|
Aktivní komparátor: Arm 2
Placebo plus enzalutamide |
Active comparator arm
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
radiological Progression-Free Survival
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: randomization up to 3 years
|
time from baseline to PSA progression |
randomization up to 3 years
|
|
Time to initiation of antineoplastic therapy
Časové okno: randomization up to 3 years
|
Time from randomization to initiation of antineoplastic therapy |
randomization up to 3 years
|
|
Time to first symptomatic skeletal event
Časové okno: 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
Časové okno: randomization up to 3 years
|
time from randomization to opiate use for prostate cancer pain |
randomization up to 3 years
|
|
Incidence of adverse events
Časové okno: 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
Časové okno: Weeks 5, 9, 13, and 17
|
plasma concentrations of talazoparib |
Weeks 5, 9, 13, and 17
|
|
Pharmacokinetic assessment of enzalutamide and its metabolite
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: randomization up to 3 years
|
change from baseline in PGI-S |
randomization up to 3 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
- rakovina prostaty
- enzalutamid
- DDR
- citlivý na kastraci
- PARP-inhibitor
- hormon-senzitivní
- metastatický hormonálně senzitivní karcinom prostaty
- Pokročilá rakovina prostaty
- Metastatický karcinom prostaty citlivý na kastraci
- mCSPC
- metastatický karcinom prostaty
- Reakce na poškození DNA
- Oprava poškození DNA
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- C3441052
- TALAPRO-3 (Jiný identifikátor: Alias Study Number)
- 2024-510809-28-00 (Identifikátor registru: CTIS (EU))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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