AzTrials
AzTrials

Prostate CancerPhase 3NCT04821622

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

A Phase 3 study testing talazoparib plus enzalutamide in people with Prostate Cancer, run by Pfizer at 312 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
talazoparib plus enzalutamide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
599 participants
Where
312 sitesin 27 countries
Study dates
12 May 2021to 28 Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

312 sites in 27 countries.

312 sites in 27 countries

United States45 sites

  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Wellstar Cobb Hospital

    Austell, Georgia, 30106

  • New Jersey Cancer Care, P.A.

    Belleville, New Jersey, 07109

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica

    Carrollton, Georgia, 30117

  • West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica

    Carrollton, Georgia, 30117

  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

    Cartersville, Georgia, 30121

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Henry Ford Medical Center - New Center One

    Detroit, Michigan, 48202

  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

    Douglasville, Georgia, 30134

  • Revive Research Institute, Inc.

    Farmington Hills, Michigan, 48334

  • Adventist Health Glendale

    Glendale, California, 91206

  • Kelsey Research Foundation

    Houston, Texas, 77005

  • Oncology Consultants, P.A.

    Houston, Texas, 77008

  • Kelsey-Seybold Clinic

    Houston, Texas, 77014

  • oncology Consultants, P.A.

    Houston, Texas, 77024

  • Kelsey-Seybold Clinic

    Houston, Texas, 77025

  • Houston Metro Urology

    Houston, Texas, 77027

  • Oncology Consultants P.A.

    Houston, Texas, 77030

  • Kelsey-Seybold Clinic

    Houston, Texas, 77055

  • Ballad Health Cancer Care - Kingsport

    Kingsport, Tennessee, 37660

  • Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Indian Path Community Hospital

    Kingsport, Tennessee, 37660

  • Comprehensive Urologic Care, SC

    Lake Barrington, Illinois, 60010

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Marietta, Georgia, 30060

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Mid-Illinois Hematology & Oncology Associates, Ltd

    Normal, Illinois, 61761

  • AdventHealth Medical Group Hematology and Oncology

    Orlando, Florida, 32804

  • Investigational Drug Services, Advent Health Orlando

    Orlando, Florida, 32804

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Premier Medical Group of the Hudson Valley PC

    Poughkeepsie, New York, 12603

  • Huntsman Cancer Institute - University of Utah

    Salt Lake City, Utah, 84112

  • Urology San Antonio

    San Antonio, Texas, 78229

  • David C. Pratt Cancer Center

    St Louis, Missouri, 63141

  • Arizona Institute of Urology, PLLC

    Tucson, Arizona, 85704

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Washington Cancer Institute at MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Texas Oncology-Deke Slayton Cancer Center

    Webster, Texas, 77598

Other trials in United States

China25 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • The First hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital Chongqing Medical University

    Chongqing, 400042

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510230

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • Lanzhou university second hospital

    Lanzhou, Gansu, 730030

  • Jiangxi Provincial Cancer Hospital

    Nanchang, Jiangxi, 330029

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226000

  • The first affiliated hospital of Ningbo university

    Ningbo, Zhejiang, 315010

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430022

  • Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

Other trials in China

Japan22 sites

  • Chiba cancer center

    Chiba, Chiba, 2608717

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Hirosaki University School of Medicine & Hospital

    Hirosaki, Aomori, 036-8563

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • National Hospital Organization Kure Medical Center and Chugoku Cancer Center

    Kure, Hiroshima, 737-0023

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • National Hospital Organization Tokyo Medical Center

    Meguro-Ku, Tokyo, 152-8902

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Osaka International Cancer Institute

    Osaka, Osaka, 5418567

  • Kindai University Hospital

    Sakai, Osaka, 590-0197

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Keio university hospital

    Shinjuku-ku, Tokyo, 160-8582

  • The University of Osaka Hospital

    Suita, Osaka, 565-0871

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Yokosukakyosai

    Yokosuka, Kanagawa, 238-8558

Other trials in Japan

Spain18 sites

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona [barcelona], 08916

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Institut Català d'Oncologia de l'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Lucus Augusti

    Lugo, Galicia, 27003

  • Hospital Universitario Gregorio Marañón

    Madrid, 28009

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, Comunidad de, 28222

  • Althaia, Xarxa Assistencial Universitària de Manresa

    Manresa, Barcelona, 08243

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitari Sant Joan de Reus

    Reus, Tarragona, 43204

  • Hospital Universitario Virgen de la Macarena

    Seville, 41009

  • Fundación Instituto Valenciano de Oncología

    Valencia, Valenciana, Comunitat, 46009

  • Hospital Politecnic Universitari La Fe

    Valencia, 46026

Other trials in Spain

Russia17 sites

  • Evimed Llc

    Chelyabinsk, 454048

  • SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"

    Chelyabinsk, 454087

  • Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")

    Ivanovo, 153040

  • Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of the

    Moscow, 117997

  • Branch of the Limited Liability Company "Hadassah Medical Ltd."

    Moscow, 121205

  • Federal State Budgetary Institution "Central Clinical Hospital with ambulance"

    Moscow, 121359

  • MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia

    Obninsk, Kaluga Oblast, 249036

  • BHI of Omsk region "Clinical Oncological Dispensary"

    Omsk, 644013

  • Private Medical Institution "Euromedservice"

    Pushkin, Sankt-Peterburg, 196603

  • Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")

    Pyatigorsk, Stavropol Kray, 357502

  • LLC "Medicina Severnoy Stolitsy"

    Saint Petersburg, 191025

  • LLC "Severo-Zapadny Medical Center"

    Saint Petersburg, 192007

  • Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"

    Samara, 443011

  • SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan

    Ufa, 450054

  • Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"

    Vologda, 160002

  • Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"

    Vologda, 160022

  • State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"

    Yaroslavl, 150054

Other trials in Russia

France16 sites

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49933

  • Clinique Belharra

    Bayonne, 64100

  • CHU Morvan de Brest

    Brest, Brittany Region, 29200

  • Hopital Henri Mondor

    Créteil, Île-de-France Region, 94010

  • Clinique Victor Hugo Le Mans

    Le Mans, Pays de la Loire Region, 72000

  • Hopital Prive le Bois

    Lille, 59000

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Bichat - Claude Bernard

    Paris, 75877

  • Hopital Lyon Sud

    Pierre-Bénite, 69310

  • Clinique La Croix du Sud - Ramsay Sante

    Quint-Fonsegrives, 31130

  • Institut Jean Godinot

    Reims, 51726

  • CHP Saint-Grégoire

    Saint-Grégoire, 35760

  • Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)

    Strasbourg, 67200

  • Institut de cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy15 sites

  • Azienda Unita Sanitaria Locale Toscana Sud-Est

    Arezzo, 52100

  • Ospedale San Donato

    Arezzo, 52100

  • Centro di Riferimento Oncologico di Aviano (CRO) IRCCS

    Aviano, PN, 33081

  • IRCCS Istituto Tumori "Giovanni Paolo II" di Bari

    Bari, 70124

  • ASST Papa Giovanni XXIII

    Bergamo, 24127

  • Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi

    Bologna, BO, 40138

  • ASST degli Spedali Civili de Brescia

    Brescia, 25123

  • ASST Cremona

    Cremona, CR, 26100

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST)

    Meldola, FC, 47014

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli

    Naples, Naples, 80131

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga- Uinta di Oncologia Polmonare

    Orbassano, 10043

  • Fondazione Casa Sollievo della Sofferenza

    San Giovanni Rotondo, FG, 71013

  • Ospedale Santa Chiara

    Trento, TN, 38122

  • Azienda Provinciale per i Servizi Sanitari, della Provincia Autonoma di Trento

    Trento, Trentino-Alto Adige, 38123

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37134

Other trials in Italy

Canada13 sites

  • Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9

  • CIUSSS- saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 5H6

  • Centre integre universitaire de sante et de services sociaux Saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 7K9

  • Urology South Shore Research

    Greenfield Park, Quebec, J4V 2H3

  • Centre of Applied Urology Research, Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Organisation Lawson Health Research Institute

    London, Ontario, N6C2R5

  • Centre Hospitalier de I'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0A9

  • CHUM - Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 0A9

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital Cancer Center

    Ottawa, Ontario, K1H 8L6

  • University Health Network-Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany12 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117

  • Urologicum Duisburg

    Duisburg, 47169

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60590

  • Universitaetsmedizin Goettingen

    Göttingen, Lower Saxony, 37075

  • Institut fuer Diagnostische und Interventionelle Radiologie

    Göttingen, 37075

  • Klinik fuer Nuklearmedizin

    Göttingen, 37075

  • Universitaetsklinik Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Jena

    Jena, Thuringia, 07747

  • Uro-/Onkologisches Zentrum

    Leipzig, 04105

  • Studienpraxis Urologie

    Nürtingen, 72622

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Urologische Gemeinschaftspraxis Wesel

    Wesel, North Rhine-Westphalia, 46483

Other trials in Germany

India12 sites

  • Artemis hospital

    Gurugram, Haryana, 122001

  • Medanta- The Medicity hospital

    Gurugram, Haryana, 122001

  • Netaji Subhas Chandra Bose Cancer Hospital

    Kolkata, West Bengal, 700094

  • Valentis Cancer Hospital

    Meerut, Uttar Pradesh, 250001

  • Bhaktivedanta Hospital and Research Institute

    Mumbai, Maharashtra, 401107

  • Indraprastha Apollo Hospital

    New Delhi, National Capital Territory of Delhi, 110076

  • Rajiv Gandhi Cancer Institute and Research Centre

    New Delhi, National Capital Territory of Delhi, 110085

  • Indraprastha Apollo Hospitals

    New Delhi, 600028

  • Sahyadri Clinical Research & Development Centre

    Pune, Maharashtra, 411004

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra, 411004

  • Sahyadri Hospitals Private Limited

    Pune, Maharashtra, 411038

  • Gujarat Hospital - Gastro and Vascular Centre

    Surat, Gujarat, 395009

Other trials in India

South Korea11 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, 58128

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, 06591

  • Ewha Womans University Mokdong Hospital

    Seoul, 07985

Other trials in South Korea

United Kingdom11 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B9 5SS

  • NHS Lothian

    Edinburgh, Midlothian, EH4 2XU

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, Devon, EX2 5DW

  • Greater Glasgow Health Board J B Russell House, Gartnavel Royal Hospital

    Glasgow, Scotland, G12 0XH

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0YN

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Imperial College Healthcare NHS Trust

    London, W6 8RF

  • Maidstone and Tunbridge Wells NHS Trust

    Maidstone, KENT, ME16 9QQ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, Lancashire, PR2 9HT

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, South Yorkshire, S10 2SJ

Other trials in United Kingdom

Bulgaria10 sites

  • Multiprofile Hospital for Active Treatment - Uni Hospital OOD

    Panagyurishte, 4500

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4000

  • Complex Oncology Center- Plovdiv EOOD

    Plovdiv, 4000

  • Independent medical-diagnostic laboratory "Medisken" EOOD

    Plovdiv, 4000

  • Complex Oncology Center - Shumen EOOD

    Shumen, 9700

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

    Sofia, 1407

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

    Sofia

  • Complex Oncology Center - Stara Zagora Ltd.

    Stara Zagora, 6003

  • MRI SMDLOD "Mediscan" Ltd

    Stara Zagora, 6003

  • UMHAT "Prof. Dr. Stoyan Kirkovich"

    Stara Zagora, 6003

Other trials in Bulgaria

Australia9 sites

  • Gallipoli Medical Research Foundation, Greenslopes Private Hospital

    Brisbane, Queensland, 4120

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Epworth Freemasons-Epworth HealthCare

    East Melbourne, Victoria, 3002

  • Cabrini Hospital

    Malvern, Victoria, 3144

  • Epworth Foundation Trading as Epworth HealthCare

    Richmond, Victoria, 3121

  • Gold Coast University Hospital

    Southport, Queensland, 4215

  • Western Health, Sunshine Hospital

    St Albans, Victoria, 3021

  • Cancer Care Wollongong Pty Limited

    Wollongong, New South Wales, 2500

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Belgium9 sites

  • Onze Lieve Vrouw Ziekenhuis Aalst

    Aalst, 9300

  • Institut Jules Bordet

    Anderlecht, 1070

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

  • AZ (Algemeen Ziekenhuis) Maria Middelares

    Ghent, 9000

  • AZ (Algemeen Ziekenhuis) Sint-Lucas

    Ghent, 9000

  • AZ (Algemeen Ziekenhuis) Groeninge

    Kortrijk, 8500

  • CHU de Liege

    Liège, 4000

  • ZNA Jan Palfijn

    Merksem, 2170

Other trials in Belgium

Ukraine9 sites

  • Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)

    Dnipro, 49005

  • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council

    Dnipro, 49102

  • Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of

    Kharkiv, 61037

  • Communal Non-Profit Enterprise "Regional Center of Oncology"

    Kharkiv, 61070

  • Asklepion Medical Center

    Khodosovka, Kyivska Oblast, 08173

  • MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department

    Kryviy Rih, Dnipropetrovsk Oblast, 50048

  • National Cancer Institute

    Kyiv, Kyivska Oblast, 03022

  • Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre

    Lviv, 79031

  • Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"

    Pliuty Village, Kyiv Oblast, 08720

Other trials in Ukraine

Argentina7 sites

  • COIBA

    Berazategui, Buenos Aires, B1884BBF

  • Centro Oncologico Korben

    Caba, C1426AGE

  • Instituto Médico Especializado Alexander Fleming

    CABA, C1426ANZ

  • Centro Medico Privado CEMAIC

    Córdoba, X5008HHW

  • Centro de Investigacion Pergamino SA - Clinica Pergamino SA

    Pergamino, Buenos Aires, B2700CPM

  • Centro Medico San Roque

    San Miguel de Tucumán, Tucumán Province, T4000IAK

  • Centro de Investigaciones Clínicas - Clínica Viedma

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Mexico7 sites

  • Preparaciones Oncológicas S.C.

    León, Guanajuato, 37178

  • Axis Heilsa S. de R.L. de C.V.

    Monterrey, Nuevo León, 64040

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460

  • Oncologia Integral Satelite SA de CV

    Naucalpan, State of Mexico, 53100

  • Oaxaca Site Management Organization

    Oaxaca City, Oaxaca, 68000

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020

  • Instituto Veracruzano en Investigación Clínica S.C.

    Veracruz, 91851

Other trials in Mexico

Slovakia7 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

    Banská Bystrica, 975 17

  • Narodny onkologicky ustav

    Bratislava, 833 10

  • Vychodoslovensky onkologicky ustav, a.s.

    Košice, 041 91

  • UROEXAM, spol. s r.o.

    Nitra, 949 01

  • POKO Poprad s.r.o.

    Poprad, 058 01

  • MILAB s.r.o.

    Prešov, 08001

  • Privatna urologicka ambulancia, s.r.o.

    Trenčín, 911 01

Other trials in Slovakia

Turkey (Türkiye)7 sites

  • Adana City Training and Research Hospital

    Adana, 01415

  • Ankara University Faculty of Medicine

    Ankara, 06620

  • Ankara City Hospital

    Ankara, 06800

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul University, Cerrahpasa Faculty of Medicine

    Istanbul, 34098

  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul, 34722

  • Inonu University, Faculty of Medicine

    Malatya, 44280

Other trials in Turkey (Türkiye)

Finland6 sites

  • Helsinki University Hospital

    Helsinki, 00029

  • Docrates Cancer Center

    Helsinki, 00180

  • Clinical Research Institute Helsinki University Central Hospital Ltd

    Helsinki, 00280

  • Kuopio University Hospital

    Kuopio, 70210

  • Tampere University Hospital

    Tampere, 33520

  • Turku University Hospital

    Turku, 20520

Other trials in Finland

South Africa6 sites

  • 15 Eton Road

    Johannesburg, Gauteng, 2193

  • Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, Gauteng, 2193

  • WCR Office

    Johannesburg, Gauteng, 2193

  • Sandton Oncology Medical Group (Pty) Ltd

    Johannesburg, Gauteng, 2196

  • Wits Clinical Research

    Parktown, Gauteng, 2193

  • Clinical Research Unit, University of Pretoria

    Pretoria, Gauteng, 0002

Other trials in South Africa

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 333

Other trials in Taiwan

Czechia5 sites

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Fakultni Nemocnice Motol a Homolka

    Prague, 150 00

  • Fakultni nemocnice Bulovka

    Praha 8- Liben, 180 81

Other trials in Czechia

Hungary4 sites

  • Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet

    Budapest, 1076

  • Országos Onkológiai Intézet

    Budapest, 1122

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Jahn Ferenc Del-pesti Korhaz es Rendelointezet

    Budapest, 1204

Other trials in Hungary

Netherlands2 sites

  • Meander Medisch Centrum

    Amersfoort, Utrecht, 3813 TZ

  • Stichting HagaZiekenhuis

    The Hague, 2545 AA

Other trials in Netherlands

Norway1 site

  • Sykehuset Innlandet Gjoevik

    Gjøvik, 2819

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Conditions
Prostate Cancer
Being tested
talazoparib plus enzalutamide, Placebo plus enzalutamide
Keywords
DDR, prostate cancer, castration-sensitive, PARP-inhibitor, hormone-sensitive, metastatic hormone-sensitive prostate cancer, Advanced prostate cancer, Metastatic castration-sensitive prostate cancer, mCSPC, enzalutamide, metastatic prostate cancer, DNA Damage Response, DNA Damage Repair
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • talazoparib plus enzalutamideDrug

    Also called Combination arm

    experimental arm

  • Placebo plus enzalutamideDrug

    Also called Monotherapy arm

    Active comparator arm

Study groups in NCT04821622
Study groupRoleWhat they receive
Arm 1ExperimentalTalazoparib plus enzalutamide
Receives: Drug: talazoparib plus enzalutamide
Arm 2Active comparatorPlacebo plus enzalutamide
Receives: Drug: Placebo plus enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. radiological Progression-Free Survival

    time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first

    Measured: randomization up to 3 years

Secondary outcomes (19)

  1. Overall Survival

    time from randomization to death from any cause

    Measured: randomization up to 4 years

  2. Objective response in measurable soft tissue disease

    proportion of patients with measurable soft tissue disease at baseline with objective response per RECIST 1.1

    Measured: randomization up to 3 years

  3. Duration of response in measurable soft tissue disease

    duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1

    Measured: randomization up to 3 years

  4. Prostate Specific Antigen (PSA) response

    proportion of patients with PSA response grater than or equal to 50%

    Measured: randomization up to 3 years

  5. Time to PSA progression

    time from baseline to PSA progression

    Measured: randomization up to 3 years

  6. Time to initiation of antineoplastic therapy

    Time from randomization to initiation of antineoplastic therapy

    Measured: randomization up to 3 years

  7. 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)

    Measured: randomization up to 3 years

  8. Opiate use for prostate cancer pain

    time from randomization to opiate use for prostate cancer pain

    Measured: randomization up to 3 years

  9. Incidence of adverse events

    AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03)

    Measured: randomization up to 3 years

  10. Pharmacokinetic assessment of talazoparib

    plasma concentrations of talazoparib

    Measured: Weeks 5, 9, 13, and 17

  11. Pharmacokinetic assessment of enzalutamide and its metabolite

    plasma concentrations of enzalutamide and its metabolite

    Measured: Weeks 5, 9, 13, and 17

  12. Relationship between ctDNA burden and outcome

    ctDNA burden at baseline and on study

    Measured: randomization up to 3 years

  13. 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)

    Measured: randomization up to 3 years

  14. 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)

    Measured: randomization up to 3 years

  15. 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

    Measured: randomization up to 3 years

  16. 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

    Measured: randomization up to 3 years

  17. 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

    Measured: randomization up to 3 years

  18. Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration

    time to definitive deterioration in disease specific urinary symptoms per EORTC QLQ-PR25

    Measured: randomization up to 3 years

  19. Patient-reported outcome: cancer specific functioning, and symptoms - change from baseline

    change from baseline in PGI-S

    Measured: randomization up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start12 May 2021
  3. Primary completion18 Feb 2026
  4. Study completion28 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
599 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04821622
Sponsor's protocol ID
C3441052
Other IDs
TALAPRO-3, 2024-510809-28-00
Status last verified
Nov 2026
First submitted
25 Mar 2021
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 42223064

  • 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.

    PubMed 37882449

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing talazoparib plus enzalutamide in people with Prostate Cancer, run by Pfizer at 312 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 312 sites in United States, China, Japan, Spain, Russia and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

radiological Progression-Free Survival (time frame: randomization up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04821622, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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