Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: talazoparib plus enzalutamide; Drug: Placebo plus enzalutamide

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 599
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Argentina
  • Caba, Argentina, C1426ANZ
    • Instituto Medico Especializado Alexander Fleming
  • Caba, Argentina, C1426AGE
    • Centro Oncológico Korben
  • Córdoba, Argentina, X5008HHW
    • Centro Medico Privado CEMAIC
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, B1884BBF
      • COIBA
    • Pergamino, Buenos Aires, Argentina, B2700CPM
      • Centro de Investigacion Pergamino SA - Clinica Pergamino SA
  • RÍO Negro
    • Viedma, RÍO Negro, Argentina, R8500ACE
      • Centro de Investigaciones Clínicas - Clínica Viedma
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, T4000IAK
      • Centro Medico San Roque
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care Centre
  • Queensland
    • Brisbane, Queensland, Australia, 4120
      • Gallipoli Medical Research Foundation, Greenslopes Private Hospital
    • Southport, Queensland, Australia, 4215
      • Gold Coast University Hospital
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Epworth Freemasons-Epworth HealthCare
    • Malvern, Victoria, Australia, 3144
      • Cabrini Hospital
    • St Albans, Victoria, Australia, 3021
      • Western Health, Sunshine Hospital
• Belgium
  • Aalst, Belgium, 9300
    • Onze Lieve Vrouw Ziekenhuis Aalst
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Gent, Belgium, 9000
    • AZ (Algemeen Ziekenhuis) Maria Middelares
  • Gent, Belgium, 9000
    • AZ (Algemeen Ziekenhuis) Sint-Lucas
  • Kortrijk, Belgium, 8500
    • AZ (Algemeen Ziekenhuis) Groeninge
  • Liege, Belgium, 4000
    • CHU de Liège
  • Merksem, Belgium, 2170
    • ZNA Jan Palfijn
• Bulgaria
  • Panagyurishte, Bulgaria, 4500
    • Multiprofile Hospital for Active Treatment - Uni Hospital OOD
  • Plovdiv, Bulgaria, 4002
    • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
  • Plovdiv, Bulgaria, 4000
    • Complex Oncology Center - Plovdiv EOOD
  • Plovdiv, Bulgaria, 4000
    • Independent medical-diagnostic laboratory "Medisken" EOOD
  • Shumen, Bulgaria, 9700
    • Complex Oncology Center - Shumen EOOD
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
  • Sofia, Bulgaria
    • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
  • Stara Zagora, Bulgaria, 6003
    • Complex Oncology Center - Stara Zagora Ltd.
  • Stara Zagora, Bulgaria, 6003
    • MRI SMDLOD "Mediscan" Ltd
  • Stara Zagora, Bulgaria, 6003
    • UMHAT "Prof. Dr. Stoyan Kirkovich"
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2V 1P9
      • Prostate Cancer Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Centre of Applied Urology Research, Nova Scotia Health Authority
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Cancer Center
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network-Princess Margaret Cancer Centre
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • CIUSSS- saguenay-Lac-Saint-Jean
    • Greenfield Park, Quebec, Canada, J4V 2H3
      • Urology South Shore Research
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Center
    • Montreal, Quebec, Canada, H2X 0A9
      • CHUM - Centre Hospitalier de l'Universite de Montreal
• China
  • Chongqing, China, 400042
    • The First Affiliated Hospital Chongqing Medical University
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou University Second Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • The First Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin medical university cancer hospital
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer hospital
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
    • Nantong, Jiangsu, China, 226000
      • Nantong Tumor Hospital
    • Suzhou, Jiangsu, China, 215004
      • The Second Affiliated Hospital of Soochow University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Provincial Cancer Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Cancer Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300211
      • The Second Hospital of Tianjin Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University
• Czechia
  • Olomouc, Czechia, 779 00
    • Fakultní nemocnice Olomouc
  • Ostrava - Poruba, Czechia, 708 52
    • Fakultni nemocnice Ostrava
  • Praha 10, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Praha 8- Liben, Czechia, 180 81
    • Fakultni nemocnice Bulovka
• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Hospital
  • Helsinki, Finland, 00180
    • Docrates Cancer Center
  • Kuopio, Finland, 70210
    • Kuopio University Hospital
  • Tampere, Finland, 33520
    • Tampere University Hospital
  • Turku, Finland, 20520
    • Turku University Hospital
• France
  • Angers Cedex 9, France, 49933
    • Centre Hospitalier Universitaire d'Angers
  • Bayonne, France, 64100
    • Clinique Belharra
  • Brest, France, 29200
    • CHU Morvan de Brest
  • LYON Cedex 08, France, 69373
    • Centre Leon Berard
  • Le Mans, France, 72000
    • Clinique Victor Hugo
  • Le Mans, France, 72000
    • Centre de cancerologie de la Sarthe
  • Lille, France, 59000
    • Hôpital Privé Le Bois
  • Paris, France, 75018
    • Hôpital Bichat - Claude Bernard
  • Paris cedex 18, France, 75877
    • Hôpital Bichat - Claude Bernard
  • Pierre-Benite, France, 69310
    • Hopital Lyon Sud
  • Quint Fonsegrives, France, 31130
    • Clinique La Croix du Sud - Ramsay Sante
  • Reims Cedex, France, 51726
    • Institut Jean Godinot
  • Saint Gregoire, France, 35760
    • CHP Saint-Gregoire
  • Strasbourg, France, 67200
    • Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)
  • Vandoeuvre-Les-Nancy, France, 54519
    • Institut de Cancérologie de Lorraine
  • Villejuif Cedex, France, 94805
    • Gustave Roussy
  • Bretagne
    • Brest, Bretagne, France, 29200
      • CHU Morvan de Brest
  • ILE DE France
    • Creteil, ILE DE France, France, 94010
      • Hopital Henri Mondor
• Germany
  • Berlin, Germany, 10117
    • Charité Universitaetsmedizin Berlin - Campus Mitte
  • Duisburg, Germany, 47169
    • Urologicum Duisburg
  • Frankfurt, Germany, 60590
    • Universitaetsklinikum Frankfurt
  • Goettingen, Germany, 37075
    • Institut fuer Diagnostische und Interventionelle Radiologie
  • Goettingen, Germany, 37075
    • Klinik fuer Nuklearmedizin
  • Heidelberg, Germany, 69120
    • Universitaetsklinik Heidelberg
  • Jena, Germany, 07747
    • Jena University Hospital
  • Leipzig, Germany, 04105
    • Uro-/Onkologisches Zentrum
  • Nuertingen, Germany, 72622
    • Studienpraxis Urologie
  • Tuebingen, Germany, 72076
    • Universitaetsklinikum Tuebingen
  • Niedersachsen
    • Göttingen, Niedersachsen, Germany, 37075
      • Universitaetsmedizin Goettingen
  • Nordrhein-westfalen
    • Wesel, Nordrhein-westfalen, Germany, 46483
      • Urologische Gemeinschaftspraxis Wesel
  • Thüringen
    • Jena, Thüringen, Germany, 07747
      • Universitatsklinikum Jena
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet
  • Budapest, Hungary, 1204
    • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
  • Budapest, Hungary, 1145
    • Uzsoki Utcai Kórház
  • Budapest, Hungary, 1076
    • Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet
• India
  • Delhi
    • New Delhi, Delhi, India, 110085
      • Rajiv Gandhi Cancer Institute and Research Centre
    • New Delhi, Delhi, India, 110076
      • Indraprastha Apollo Hospital
  • Gujarat
    • Surat, Gujarat, India, 395009
      • Gujarat Hospital - Gastro and Vascular Centre
  • Haryana
    • Gurugram, Haryana, India, 122001
      • Artemis Hospital
    • Gurugram, Haryana, India, 122001
      • Medanta- The Medicity hospital
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 012
      • Tata Memorial Hospital
    • Mumbai, Thane, Maharashtra, India, 401107
      • Bhakti Vedanta Hospital and Research Institute
    • Mumbai, Thane, Maharashtra, India, 401107
      • Bhaktivedanta Hospital and research institute
    • Pune, Maharashtra, India, 411004
      • Sahyadri Super Speciality Hospital
    • Pune, Maharashtra, India, 411004
      • Sahyadri Clinical Research & Development Centre
  • Uttar Pradesh
    • Meerut, Uttar Pradesh, India, 250001
      • Valentis Cancer Hospital
  • WEST Bengal
    • Kolkata, WEST Bengal, India, 700094
      • Netaji Subhas Chandra Bose Cancer Hospital
• Italy
  • Arezzo, Italy, 52100
    • Ospedale San Donato
  • Bari, Italy, 70124
    • IRCCS Istituto Tumori "Giovanni Paolo II" di Bari
  • Bergamo, Italy, 24127
    • ASST Papa Giovanni XXIII
  • Brescia, Italy, 25123
    • ASST degli Spedali Civili de Brescia
  • Verona, Italy, 37134
    • Azienda Ospedaliera Universitaria Integrata Verona
  • BO
    • Bologna, BO, Italy, 40138
      • Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
  • CR
    • Cremona, CR, Italy, 26100
      • ASST Cremona
  • FC
    • Meldola, FC, Italy, 47014
      • Istituto Romagnolo per lo Studio dei Tum.ori "Dino Amadori" (IRST)
  • FG
    • San Giovanni Rotondo, FG, Italy, 71013
      • Fondazione Casa Sollievo della Sofferenza
  • Naples
    • Napoli, Naples, Italy, 80131
      • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
  • PN
    • Aviano, PN, Italy, 33081
      • Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
  • TN
    • Trento, TN, Italy, 38122
      • Ospedale Santa Chiara
  • TO
    • Orbassano, TO, Italy, 10043
      • Aou San Luigi Gonzaga
• Japan
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Kumamoto, Japan, 860-0008
    • National Hospital Organization Kumamoto Medical Center
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 466-8560
      • Nagoya University Hospital
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8563
      • Hirosaki University School of Medicine & Hospital
  • Chiba
    • Chiba City, Chiba, Japan, 2608717
      • Chiba Cancer Center
    • Chiba-shi, Chiba, Japan, 260-8717
      • Chiba Cancer Center
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 811-1395
      • National Hospital Organization Kyushu Cancer Center
  • Hiroshima
    • Kure, Hiroshima, Japan, 737-0023
      • National Hospital Organization Kure Medical Center and Chugoku Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • National Hospital Organization Hokkaido Cancer Center
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
    • Yokosuka, Kanagawa, Japan, 238-8558
      • Yokosukakyosai
  • Osaka
    • Osaka-shi, Osaka, Japan, 5418567
      • Osaka International Cancer Institute
    • Osakasayama, Osaka, Japan, 589-8511
      • Kindai University Hospital
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
  • Tokyo
    • Meguro-Ku, Tokyo, Japan, 152-8902
      • National Hospital Organization Tokyo Medical Center
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Chilgok Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 07985
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 06591
    • The Catholic Univ. of Korea Seoul St. Mary's Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center
  • Jeollanam-do
    • Hwasun-gun, Jeollanam-do, Korea, Republic of, 58128
      • Chonnam National University Hwasun Hospital
  • Kyǒnggi-do
    • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
  • Seoul-teukbyeolsi
    • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 06351
      • Samsung Medical Center
• Mexico
  • Oaxaca, Mexico, 68020
    • Centro de Investigacion Clinica de Oaxaca
  • Veracruz, Mexico, 91851
    • Instituto Veracruzano en Investigación Clínica S.C.
  • Estado DE Mexico
    • Naucalpan de Juarez, Estado DE Mexico, Mexico, 53100
      • Oncologia Integral Satelite SA de CV
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37178
      • Preparaciones Oncológicas S.C.
  • Nuevo LEÓN
    • Monterrey, Nuevo LEÓN, Mexico, 64040
      • Axis Heilsa S. de R.L. de C.V.
    • Monterrey, Nuevo LEÓN, Mexico, 64460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Oaxaca
    • Oaxaca de Juarez, Oaxaca, Mexico, 68000
      • Oaxaca Site Management Organization
• Netherlands
  • Den Haag, Netherlands, 2545 AA
    • Stichting HagaZiekenhuis
  • Utrecht
    • Amersfoort, Utrecht, Netherlands, 3813 TZ
      • Meander Medisch Centrum
• Norway
  • Gjoevik, Norway, 2819
    • Sykehuset Innlandet Gjoevik
• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • Evimed LLC
  • Chelyabinsk, Russian Federation, 454087
    • SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
  • Ivanovo, Russian Federation, 153040
    • Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")
  • Moscow, Russian Federation, 121205
    • Branch of the Limited Liability Company "Hadassah Medical Ltd."
  • Moscow, Russian Federation, 121359
    • Federal State Budgetary Institution "Central Clinical Hospital with ambulance"
  • Moscow, Russian Federation, 117997
    • Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of t
  • Omsk, Russian Federation, 644013
    • BHI of Omsk region "Clinical Oncological Dispensary"
  • Saint-Petersburg, Russian Federation, 191025
    • LLC "Medicina Severnoy Stolitsy"
  • Saint-Petersburg, Russian Federation, 192007
    • LLC "Severo-Zapadny Medical Center"
  • Samara, Russian Federation, 443011
    • Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"
  • Ufa, Russian Federation, 450054
    • SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
  • Vologda, Russian Federation, 160022
    • Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
  • Vologda, Russian Federation, 160002
    • Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
  • Yaroslavl, Russian Federation, 150054
    • State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
  • Kaluga Region
    • Obninsk, Kaluga Region, Russian Federation, 249036
      • MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia
  • Saint-petersburg
    • Pushkin, Saint-petersburg, Russian Federation, 196603
      • Private medical institution "Euromedservice"
  • Stavropol Region
    • Pyatigorsk, Stavropol Region, Russian Federation, 357502
      • Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
  • Bratislava, Slovakia, 833 10
    • Narodny Onkologicky Ustav
  • Kosice, Slovakia, 041 91
    • Vychodoslovensky onkologicky ustav, a.s.
  • Nitra, Slovakia, 949 01
    • UROEXAM, spol. s r.o.
  • Poprad, Slovakia, 058 21
    • POKO Poprad s.r.o.
  • Presov, Slovakia, 08 001
    • MILAB s.r.o.
  • Trencin, Slovakia, 911 01
    • Privatna urologicka ambulancia, s.r.o.
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Charlotte Maxeke Johannesburg Academic Hospital
    • Johannesburg, Gauteng, South Africa, 2193
      • 15 Eton Road
    • Johannesburg, Gauteng, South Africa, 2193
      • WCR Office
    • Johannesburg, Gauteng, South Africa, 2196
      • Sandton Oncology Medical Group (Pty) Ltd
    • Parktown, Johannesburg, Gauteng, South Africa, 2193
      • WITS Clinical Research
    • Pretoria, Gauteng, South Africa, 0002
      • Clinical Research Unit, University of Pretoria
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofía
  • Madrid, Spain, 28040
    • Hospital Clínico San Carlos
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center
  • Madrid, Spain, 28009
    • Hospital Universitario Gregorio Marañon
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen De La Macarena
  • Valencia, Spain, 46026
    • Hospital Politecnic Universitari La Fe
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
      • ALTHAIA, Xarxa Assistencial Universitària de Manresa
  • Barcelona [barcelona]
    • Badalona, Barcelona [barcelona], Spain, 08916
      • Hospital Germans Trias i Pujol
  • Galicia
    • Lugo, Galicia, Spain, 27003
      • Hospital Universitario Lucus Augusti
  • Madrid, Comunidad DE
    • Majadahonda, Madrid, Comunidad DE, Spain, 28222
      • Hospital Universitario Puerta de Hierro
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Complejo Hospitalario de Navarra
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Hospital Universitari Sant Joan de Reus
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46009
      • Fundacion Instituto Valenciano de Oncologia
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital
• Turkey
  • Adana, Turkey, 01415
    • Adana City Training and Research Hospital
  • Ankara, Turkey, 06800
    • Ankara City Hospital
  • Ankara, Turkey, 06620
    • Ankara University Faculty of Medicine
  • Edirne, Turkey, 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey, 34098
    • Istanbul University, Cerrahpasa Faculty of Medicine
  • Istanbul, Turkey, 34722
    • Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Malatya, Turkey, 44280
    • Inonu University, Faculty of Medicine
  • Ankara
    • Bilkent, Ankara, Turkey, 06800
      • Ankara Bilkent Sehir Hastanesi
• Ukraine
  • Dnipro, Ukraine, 49102
    • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
  • Dnipro, Ukraine, 49005
    • Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)
  • Ivano-Frankivsk, Ukraine, 76008
    • Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
  • Kharkiv, Ukraine, 61070
    • Communal Non-Profit Enterprise "Regional Center of Oncology"
  • Kharkiv, Ukraine, 61037
    • Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of
  • Lviv, Ukraine, 79031
    • Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre
  • Dnipropetrovska Oblast
    • Kryviy Rih, Dnipropetrovska Oblast, Ukraine, 50048
      • MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
  • KYIV Region
    • Pliuty Village, KYIV Region, Ukraine, 08720
      • Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"
  • Kyivska Oblast
    • Khodosivka, Kyivska Oblast, Ukraine, 08173
      • Asklepion Medical Center
    • Kyiv, Kyivska Oblast, Ukraine, 03022
      • National Cancer Institute
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • University Hospitals Birmingham NHS Foundation Trust
  • Glasgow, United Kingdom, G12 0YN
    • NHS Greater Glasgow and Clyde
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, W6 8RF
    • Imperial College Healthcare NHS Trust
  • Manchester, United Kingdom, M20 4BX
    • The Christie Nhs Foundation Trust
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon and Exeter NHS Foundation Trust
  • Kent
    • Maidstone, Kent, United Kingdom, ME16 9QQ
      • Maidstone and Tunbridge Wells NHS Trust
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR2 9HT
      • Lancashire Teaching Hospitals NHS Foundation Trust
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH4 2XU
      • NHS Lothian
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2SJ
      • Sheffield Teaching Hospitals NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Arizona Institute of Urology, PLLC
  • California
    • Beverly Hills, California, United States, 90211
      • Beverly Hills Cancer Center
    • Glendale, California, United States, 91206
      • Adventist Health Glendale
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare System
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
    • Washington, District of Columbia, United States, 20010
      • Washington Cancer Institute at MedStar Washington Hospital Center
  • Florida
    • Orlando, Florida, United States, 32804
      • Investigational Drug Services, Advent Health Orlando
    • Orlando, Florida, United States, 32804
      • Investigational Drug Services
    • Orlando, Florida, United States, 32804
      • AdventHealth Medical Group Hematology and Oncology
  • Georgia
    • Austell, Georgia, United States, 30106
      • WellStar Cobb Hospital
    • Austell, Georgia, United States, 30106
      • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
    • Carrollton, Georgia, United States, 30117
      • Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
    • Carrollton, Georgia, United States, 30117
      • West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
    • Cartersville, Georgia, United States, 30121
      • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
    • Douglasville, Georgia, United States, 30134
      • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
  • Illinois
    • Lake Barrington, Illinois, United States, 60010
      • Comprehensive Urologic Care, SC
    • Normal, Illinois, United States, 61761
      • Mid-Illinois Hematology & Oncology Associates, Ltd
  • Louisiana
    • Shreveport, Louisiana, United States, 71115
      • Willis Knighton Advanced Urology
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Farmington Hills, Michigan, United States, 48334
      • Revive Research Institute, Inc.
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • David C. Pratt Cancer Center
  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • New Jersey Cancer Care, P.A.
  • New York
    • Poughkeepsie, New York, United States, 12603
      • Premier Medical Group of the Hudson Valley PC
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Providence Cancer Institute Clackamas Clinic
    • Newberg, Oregon, United States, 97132
      • Providence Cancer Institute Newberg Clinic
    • Oregon City, Oregon, United States, 97045
      • Providence Cancer Institute Willamette Falls
    • Portland, Oregon, United States, 97213
      • Providence Cancer Institute Franz Clinic
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97225
      • Providence Oncology and Hematology Care Clinic - Westside
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Keystone Urology Specialists
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Parkway Surgery Center
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Bristol Regional Medical Center
    • Kingsport, Tennessee, United States, 37660
      • Ballad Health Cancer Care - Kingsport
    • Kingsport, Tennessee, United States, 37660
      • Indian Path Community Hospital
    • Kingsport, Tennessee, United States, 37660
      • Holston Valley Hospital and Medical Center
  • Texas
    • Houston, Texas, United States, 77005
      • Kelsey Research Foundation
    • Houston, Texas, United States, 77025
      • Kelsey-Seybold Clinic
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
    • Houston, Texas, United States, 77024
      • Oncology Consultants, P.A.
    • Houston, Texas, United States, 77008
      • Oncology Consultants, P.A.
    • Houston, Texas, United States, 77030
      • Oncology Consultants P.A.
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio, PA dba USA Clinical Trials
    • San Antonio, Texas, United States, 78258
      • Baptist M&S Imaging (STONE OAK)
    • Webster, Texas, United States, 77598
      • Texas Oncology-Deke Slayton Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute - University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male participants at least 18 years of age at screening (20 years for Japan, 19 years for Republic of Korea).
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Prior treatment of mCSPC with docetaxel is not permitted.
9. Treatment with estrogens, cyproterone acetate, or first-generation anti-androgens is allowed until randomization.
10. 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.
11. 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.
12. ECOG performance status 0 or 1.

13. 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.
14. 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.
15. 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).
16. 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.
17. Capable of giving signed informed consent.
18. For France only: Participants affiliated with the social security system or beneficiaries of an equivalent system.

Exclusion Criteria:

1. 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.
2. 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.
3. Major surgery (as defined by the investigator) within 4 weeks before randomization.
4. Known or suspected brain metastasis or active leptomeningeal disease.
5. Symptomatic or impending spinal cord compression or cauda equina syndrome.

6. 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.
7. In the opinion of the investigator, any clinically significant gastrointestinal disorder affecting absorption.

8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. Prior treatment with a PARPi, or known or possible hypersensitivity to enzalutamide, any of enzalutamide capsule excipients or to any talazoparib/placebo capsule excipients.
14. Prior treatment in any setting with NHT, except as described in Inclusion Criterion #10.
15. Current use of potent P-gp inhibitors within 7 days prior to randomization.
16. 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.
17. 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.
18. 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.
19. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Talazoparib plus enzalutamide	Drug: talazoparib plus enzalutamide; experimental arm; Other Names: Combination arm
Active Comparator: Arm 2; Placebo plus enzalutamide	Drug: Placebo plus enzalutamide; Active comparator arm; Other Names: Monotherapy arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiological Progression-Free Survival	time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first	randomization up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	time from randomization to death from any cause	randomization up to 4 years
Objective response in measurable soft tissue disease	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	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	proportion of patients with PSA response grater than or equal to 50%	randomization up to 3 years
Time to PSA progression	time from baseline to PSA progression	randomization up to 3 years
Time to initiation of antineoplastic therapy	Time from randomization to initiation of antineoplastic therapy	randomization up to 3 years
Time to first symptomatic skeletal event	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	time from randomization to opiate use for prostate cancer pain	randomization up to 3 years
Incidence of adverse events	AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03)	randomization up to 3 years
Pharmacokinetic assessment of talazoparib	plasma concentrations of talazoparib	Weeks 5, 9, 13, and 17
Pharmacokinetic assessment of enzalutamide and its metabolite	plasma concentrations of enzalutamide and its metabolite	Weeks 5, 9, 13, and 17
Relationship between ctDNA burden and outcome	ctDNA burden at baseline and on study	randomization up to 3 years
Patient-reported outcomes in pain symptoms - change from baseline	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	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	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	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	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	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	change from baseline in PGI-S	randomization up to 3 years

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Astellas Pharma Inc
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Estimated): September 18, 2025
• Study Completion (Estimated): August 7, 2027

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: prostate cancer; enzalutamide; DDR; castration-sensitive; PARP-inhibitor; hormone-sensitive; metastatic hormone-sensitive prostate cancer; Advanced prostate cancer; Metastatic castration-sensitive prostate cancer; mCSPC; metastatic prostate cancer; DNA Damage Response; DNA Damage Repair
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Talazoparib
• Other Study ID Numbers: C3441052; TALAPRO-3 (Other Identifier: Alias Study Number); 2021-000248-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No