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
3 other identifiers
interventional
599
27 countries
313
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started May 2021
Typical duration for phase_3 prostate-cancer
313 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2021
CompletedStudy Start
First participant enrolled
May 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2027
ExpectedJuly 22, 2026
July 1, 2026
4.8 years
March 25, 2021
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (19)
Overall Survival
randomization up to 4 years
Objective response in measurable soft tissue disease
randomization up to 3 years
Duration of response in measurable soft tissue disease
randomization up to 3 years
Prostate Specific Antigen (PSA) response
randomization up to 3 years
Time to PSA progression
randomization up to 3 years
- +14 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALTalazoparib plus enzalutamide
Arm 2
ACTIVE COMPARATORPlacebo plus enzalutamide
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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.
- +6 more criteria
You may not qualify if:
- 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Astellas Pharma Inccollaborator
Study Sites (313)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Arizona Institute of Urology, PLLC
Tucson, Arizona, 85704, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
Adventist Health Glendale
Glendale, California, 91206, United States
VA Long Beach Healthcare System
Long Beach, California, 90822, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
AdventHealth Medical Group Hematology and Oncology
Orlando, Florida, 32804, United States
Investigational Drug Services, Advent Health Orlando
Orlando, Florida, 32804, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Austell, Georgia, 30106, United States
Wellstar Cobb Hospital
Austell, Georgia, 30106, United States
Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
Carrollton, Georgia, 30117, United States
West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
Carrollton, Georgia, 30117, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Cartersville, Georgia, 30121, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Douglasville, Georgia, 30134, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060, United States
Comprehensive Urologic Care, SC
Lake Barrington, Illinois, 60010, United States
Mid-Illinois Hematology & Oncology Associates, Ltd
Normal, Illinois, 61761, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202, United States
Revive Research Institute, Inc.
Farmington Hills, Michigan, 48334, United States
David C. Pratt Cancer Center
St Louis, Missouri, 63141, United States
New Jersey Cancer Care, P.A.
Belleville, New Jersey, 07109, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12603, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572, United States
Parkway Surgery Center
Myrtle Beach, South Carolina, 29572, United States
Bristol Regional Medical Center
Bristol, Tennessee, 37620, United States
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660, United States
Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660, United States
Indian Path Community Hospital
Kingsport, Tennessee, 37660, United States
Kelsey Research Foundation
Houston, Texas, 77005, United States
Oncology Consultants, P.A.
Houston, Texas, 77008, United States
Kelsey-Seybold Clinic
Houston, Texas, 77014, United States
oncology Consultants, P.A.
Houston, Texas, 77024, United States
Kelsey-Seybold Clinic
Houston, Texas, 77025, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Oncology Consultants P.A.
Houston, Texas, 77030, United States
Kelsey-Seybold Clinic
Houston, Texas, 77055, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Texas Oncology-Deke Slayton Cancer Center
Webster, Texas, 77598, United States
Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, 84112, United States
COIBA
Berazategui, Buenos Aires, B1884BBF, Argentina
Centro de Investigacion Pergamino SA - Clinica Pergamino SA
Pergamino, Buenos Aires, B2700CPM, Argentina
Centro de Investigaciones Clínicas - Clínica Viedma
Viedma, Río Negro Province, R8500ACE, Argentina
Centro Medico San Roque
San Miguel de Tucumán, Tucumán Province, T4000IAK, Argentina
Centro Oncologico Korben
Caba, C1426AGE, Argentina
Instituto Médico Especializado Alexander Fleming
CABA, C1426ANZ, Argentina
Centro Medico Privado CEMAIC
Córdoba, X5008HHW, Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales, 2500, Australia
Gallipoli Medical Research Foundation, Greenslopes Private Hospital
Brisbane, Queensland, 4120, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Epworth Freemasons-Epworth HealthCare
East Melbourne, Victoria, 3002, Australia
Cabrini Hospital
Malvern, Victoria, 3144, Australia
Epworth Foundation Trading as Epworth HealthCare
Richmond, Victoria, 3121, Australia
Western Health, Sunshine Hospital
St Albans, Victoria, 3021, Australia
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, 9300, Belgium
Institut Jules Bordet
Anderlecht, 1070, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
AZ (Algemeen Ziekenhuis) Maria Middelares
Ghent, 9000, Belgium
AZ (Algemeen Ziekenhuis) Sint-Lucas
Ghent, 9000, Belgium
AZ (Algemeen Ziekenhuis) Groeninge
Kortrijk, 8500, Belgium
CHU de Liege
Liège, 4000, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
Panagyurishte, 4500, Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4000, Bulgaria
Complex Oncology Center- Plovdiv EOOD
Plovdiv, 4000, Bulgaria
Independent medical-diagnostic laboratory "Medisken" EOOD
Plovdiv, 4000, Bulgaria
Complex Oncology Center - Shumen EOOD
Shumen, 9700, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, 1407, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
Sofia, Bulgaria
Complex Oncology Center - Stara Zagora Ltd.
Stara Zagora, 6003, Bulgaria
MRI SMDLOD "Mediscan" Ltd
Stara Zagora, 6003, Bulgaria
UMHAT "Prof. Dr. Stoyan Kirkovich"
Stara Zagora, 6003, Bulgaria
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9, Canada
Centre of Applied Urology Research, Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Organisation Lawson Health Research Institute
London, Ontario, N6C2R5, Canada
The Ottawa Hospital Cancer Center
Ottawa, Ontario, K1H 8L6, Canada
University Health Network-Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6, Canada
Centre integre universitaire de sante et de services sociaux Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 7K9, Canada
Urology South Shore Research
Greenfield Park, Quebec, J4V 2H3, Canada
Centre Hospitalier de I'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9, Canada
CHUM - Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Lanzhou university second hospital
Lanzhou, Gansu, 730030, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430022, China
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226000, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, 330029, China
The First hospital of Jilin University
Changchun, Jilin, 130021, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, 315010, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The First Affiliated Hospital Chongqing Medical University
Chongqing, 400042, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, 708 52, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Fakultni Nemocnice Motol a Homolka
Prague, 150 00, Czechia
Fakultni nemocnice Bulovka
Praha 8- Liben, 180 81, Czechia
Helsinki University Hospital
Helsinki, 00029, Finland
Docrates Cancer Center
Helsinki, 00180, Finland
Clinical Research Institute Helsinki University Central Hospital Ltd
Helsinki, 00280, Finland
Kuopio University Hospital
Kuopio, 70210, Finland
Tampere University Hospital
Tampere, 33520, Finland
Turku University Hospital
Turku, 20520, Finland
CHU Morvan de Brest
Brest, Brittany Region, 29200, France
Clinique Victor Hugo Le Mans
Le Mans, Pays de la Loire Region, 72000, France
Centre Hospitalier Universitaire d'Angers
Angers, 49933, France
Clinique Belharra
Bayonne, 64100, France
Hopital Prive le Bois
Lille, 59000, France
Centre Leon Berard
Lyon, 69373, France
Hopital Bichat - Claude Bernard
Paris, 75018, France
Hopital Bichat - Claude Bernard
Paris, 75877, France
Hopital Lyon Sud
Pierre-Bénite, 69310, France
Clinique La Croix du Sud - Ramsay Sante
Quint-Fonsegrives, 31130, France
Institut Jean Godinot
Reims, 51726, France
CHP Saint-Grégoire
Saint-Grégoire, 35760, France
Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)
Strasbourg, 67200, France
Institut de cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Gustave Roussy
Villejuif, 94805, France
Hopital Henri Mondor
Créteil, Île-de-France Region, 94010, France
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, 37075, Germany
Urologische Gemeinschaftspraxis Wesel
Wesel, North Rhine-Westphalia, 46483, Germany
Universitätsklinikum Jena
Jena, Thuringia, 07747, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117, Germany
Urologicum Duisburg
Duisburg, 47169, Germany
Universitaetsklinikum Frankfurt
Frankfurt, 60590, Germany
Institut fuer Diagnostische und Interventionelle Radiologie
Göttingen, 37075, Germany
Klinik fuer Nuklearmedizin
Göttingen, 37075, Germany
Universitaetsklinik Heidelberg
Heidelberg, 69120, Germany
Uro-/Onkologisches Zentrum
Leipzig, 04105, Germany
Studienpraxis Urologie
Nürtingen, 72622, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet
Budapest, 1076, Hungary
Országos Onkológiai Intézet
Budapest, 1122, Hungary
Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, 1204, Hungary
Gujarat Hospital - Gastro and Vascular Centre
Surat, Gujarat, 395009, India
Artemis hospital
Gurugram, Haryana, 122001, India
Medanta- The Medicity hospital
Gurugram, Haryana, 122001, India
Bhaktivedanta Hospital and Research Institute
Mumbai, Maharashtra, 401107, India
Sahyadri Clinical Research & Development Centre
Pune, Maharashtra, 411004, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004, India
Sahyadri Hospitals Private Limited
Pune, Maharashtra, 411038, India
Indraprastha Apollo Hospital
New Delhi, National Capital Territory of Delhi, 110076, India
Rajiv Gandhi Cancer Institute and Research Centre
New Delhi, National Capital Territory of Delhi, 110085, India
Valentis Cancer Hospital
Meerut, Uttar Pradesh, 250001, India
Netaji Subhas Chandra Bose Cancer Hospital
Kolkata, West Bengal, 700094, India
Indraprastha Apollo Hospitals
New Delhi, 600028, India
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
Bologna, BO, 40138, Italy
ASST Cremona
Cremona, CR, 26100, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST)
Meldola, FC, 47014, Italy
Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, 71013, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
Naples, Naples, 80131, Italy
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
Aviano, PN, 33081, Italy
Ospedale Santa Chiara
Trento, TN, 38122, Italy
Azienda Provinciale per i Servizi Sanitari, della Provincia Autonoma di Trento
Trento, Trentino-Alto Adige, 38123, Italy
Azienda Unita Sanitaria Locale Toscana Sud-Est
Arezzo, 52100, Italy
Ospedale San Donato
Arezzo, 52100, Italy
IRCCS Istituto Tumori "Giovanni Paolo II" di Bari
Bari, 70124, Italy
ASST Papa Giovanni XXIII
Bergamo, 24127, Italy
ASST degli Spedali Civili de Brescia
Brescia, 25123, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga- Uinta di Oncologia Polmonare
Orbassano, 10043, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37134, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Hirosaki University School of Medicine & Hospital
Hirosaki, Aomori, 036-8563, Japan
Chiba cancer center
Chiba, Chiba, 2608717, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Kure, Hiroshima, 737-0023, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Yokosukakyosai
Yokosuka, Kanagawa, 238-8558, Japan
Osaka International Cancer Institute
Osaka, Osaka, 5418567, Japan
Kindai University Hospital
Sakai, Osaka, 590-0197, Japan
The University of Osaka Hospital
Suita, Osaka, 565-0871, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Tokyo, 152-8902, Japan
Keio university hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Preparaciones Oncológicas S.C.
León, Guanajuato, 37178, Mexico
Axis Heilsa S. de R.L. de C.V.
Monterrey, Nuevo León, 64040, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460, Mexico
Oaxaca Site Management Organization
Oaxaca City, Oaxaca, 68000, Mexico
Oncologia Integral Satelite SA de CV
Naucalpan, State of Mexico, 53100, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020, Mexico
Instituto Veracruzano en Investigación Clínica S.C.
Veracruz, 91851, Mexico
Meander Medisch Centrum
Amersfoort, Utrecht, 3813 TZ, Netherlands
Stichting HagaZiekenhuis
The Hague, 2545 AA, Netherlands
Sykehuset Innlandet Gjoevik
Gjøvik, 2819, Norway
MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia
Obninsk, Kaluga Oblast, 249036, Russia
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, 196603, Russia
Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")
Pyatigorsk, Stavropol Kray, 357502, Russia
Evimed Llc
Chelyabinsk, 454048, Russia
SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
Chelyabinsk, 454087, Russia
Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")
Ivanovo, 153040, Russia
Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of the
Moscow, 117997, Russia
Branch of the Limited Liability Company "Hadassah Medical Ltd."
Moscow, 121205, Russia
Federal State Budgetary Institution "Central Clinical Hospital with ambulance"
Moscow, 121359, Russia
BHI of Omsk region "Clinical Oncological Dispensary"
Omsk, 644013, Russia
LLC "Medicina Severnoy Stolitsy"
Saint Petersburg, 191025, Russia
LLC "Severo-Zapadny Medical Center"
Saint Petersburg, 192007, Russia
Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"
Samara, 443011, Russia
SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
Ufa, 450054, Russia
Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
Vologda, 160002, Russia
Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
Vologda, 160022, Russia
State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, 150054, Russia
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Banská Bystrica, 975 17, Slovakia
Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Košice, 041 91, Slovakia
UROEXAM, spol. s r.o.
Nitra, 949 01, Slovakia
POKO Poprad s.r.o.
Poprad, 058 01, Slovakia
MILAB s.r.o.
Prešov, 08001, Slovakia
Privatna urologicka ambulancia, s.r.o.
Trenčín, 911 01, Slovakia
15 Eton Road
Johannesburg, Gauteng, 2193, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2193, South Africa
WCR Office
Johannesburg, Gauteng, 2193, South Africa
Sandton Oncology Medical Group (Pty) Ltd
Johannesburg, Gauteng, 2196, South Africa
Wits Clinical Research
Parktown, Gauteng, 2193, South Africa
Clinical Research Unit, University of Pretoria
Pretoria, Gauteng, 0002, South Africa
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 58128, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona], 08916, Spain
Institut Català d'Oncologia de l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243, Spain
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Comunidad de, 28222, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43204, Spain
Fundación Instituto Valenciano de Oncología
Valencia, Valenciana, Comunitat, 46009, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario Gregorio Marañón
Madrid, 28009, Spain
MD Anderson Cancer Center
Madrid, 28033, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Virgen de la Macarena
Seville, 41009, Spain
Hospital Politecnic Universitari La Fe
Valencia, 46026, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan City, 333, Taiwan
Adana City Training and Research Hospital
Adana, 01415, Turkey (Türkiye)
Ankara University Faculty of Medicine
Ankara, 06620, Turkey (Türkiye)
Ankara City Hospital
Ankara, 06800, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, 22030, Turkey (Türkiye)
Istanbul University, Cerrahpasa Faculty of Medicine
Istanbul, 34098, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 34722, Turkey (Türkiye)
Inonu University, Faculty of Medicine
Malatya, 44280, Turkey (Türkiye)
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
Kryviy Rih, Dnipropetrovsk Oblast, 50048, Ukraine
Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"
Pliuty Village, Kyiv Oblast, 08720, Ukraine
Asklepion Medical Center
Khodosovka, Kyivska Oblast, 08173, Ukraine
National Cancer Institute
Kyiv, Kyivska Oblast, 03022, Ukraine
Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)
Dnipro, 49005, Ukraine
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
Dnipro, 49102, Ukraine
Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of
Kharkiv, 61037, Ukraine
Communal Non-Profit Enterprise "Regional Center of Oncology"
Kharkiv, 61070, Ukraine
Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre
Lviv, 79031, Ukraine
Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, KENT, ME16 9QQ, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, Lancashire, PR2 9HT, United Kingdom
NHS Lothian
Edinburgh, Midlothian, EH4 2XU, United Kingdom
Greater Glasgow Health Board J B Russell House, Gartnavel Royal Hospital
Glasgow, Scotland, G12 0XH, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2SJ, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B9 5SS, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G12 0YN, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
Imperial College Healthcare NHS Trust
London, W6 8RF, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Publications (2)
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 May 30. doi: 10.1056/NEJMoa2604126. Online ahead of print.
PMID: 42223064DERIVEDAgarwal 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.
PMID: 37882449DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2021
First Posted
March 29, 2021
Study Start
May 12, 2021
Primary Completion
February 18, 2026
Study Completion (Estimated)
August 28, 2027
Last Updated
July 22, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
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.