AzTrials
AzTrials

mCRPCPhase 3TALAPRO-2NCT03395197

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

A Phase 3 study testing Talazoparib with enzalutamide in people with mCRPC, run by Pfizer at 370 sites in 26 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
mCRPC
What is being tested?
Talazoparib with enzalutamide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,054 participants
Where
370 sitesin 26 countries
Study dates
18 Dec 2017to 30 Jun 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features
  • Asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC) (score on BPI-SF Question #3 must be < 4).
  • For enrollment into Part 2 only (optional in Part 1): assessment of DDR mutation status
  • Consent to a saliva sample collection for a germline comparator unless prohibited by local regulations or ethics committee decision (optional for patients in Part 1).
  • Surgically or medically castrated, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening.
  • Metastatic disease in bone documented on bone scan or in soft tissue documented on CT/MRI scan.
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  • Progressive disease at study entry in the setting of medical or surgical castration as defined by 1 or more of the following 3 criteria:
  • Prostate specific antigen (PSA) progression defined by a minimum of 2 rising PSA values from 3 consecutive assessments with an interval of at least 7 days between assessments..
  • Soft tissue disease progression as defined by RECIST 1.1.
  • Bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3) with 2 or more new metastatic bone lesions on a whole body radionuclide bone scan.
  • Ongoing bisphosphonate or denosumab use prior to Day 1 (Part 1) or randomization (Part 2) is allowed but not mandatory.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Life expectancy ≥ 12 months as assessed by the investigator.
  • Able to swallow the study drug and have no known intolerance to study drugs or excipients.
  • Must agree to use a condom when having sex with a partner from the time of the first dose of study drug through 4 months after last dose of study treatment. 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 when having sex with a non pregnant female partner of childbearing potential.
  • Must agree not to donate sperm from the first dose of study drug to 4 months after the last dose of study drug.
  • Evidence of a personally signed and dated informed consent document (and molecular prescreening consent if appropriate) indicating that the patient [or a legally acceptable representative/legal guardian] has been informed of all pertinent aspects of the study.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Who cannot join

  • Any prior systemic cancer treatment initiated in in the non metastatic CRPC and mCRPC disease state.
  • Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation.
  • Prior treatment with second-generation androgen receptor inhibitors (enzalutamide, apalutamide, and darolutamide), a PARP inhibitor, cyclophosphamide, or mitoxantrone for prostate cancer.
  • Prior treatment with platinum-based chemotherapy within 6 months (from the last dose) prior to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on platinum-based therapy within 6 months (from the last dose).
  • Treatment with cytotoxic chemotherapy, biologic therapy including sipuleucel T, or radionuclide therapy received in the castration-sensitive prostate cancer is NOT exclusionary if discontinued in the 28 days prior to Day 1 (Part 1) or randomization (Part 2).
  • Treatment with any investigational agent within 4 weeks before Day 1 (Part 1) or randomization (Part 2).
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  • Prior treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days prior to Day 1 (Part 1) or randomization (Part 2).
  • Current use of potent P-gp inhibitors within 7 days prior to Day 1 (Part 1) or randomization (Part 2).
  • Major surgery (as defined by the investigator) within 2 weeks before Day 1 (Part 1) or randomization (Part 2), or palliative localized radiation therapy within 3 weeks before randomization (Part 2).
  • Clinically significant cardiovascular disease
  • Significant renal dysfunction as defined by any of the following laboratory abnormalities:
  • Renal: eGFR < 30 mL/min/1.73 m2 by the MDRD equation (available via www.mdrd.com).
  • Patients enrolled in Part 1 only: Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2) at screening.
  • Significant hepatic dysfunction as defined by any of the following laboratory abnormalities on screening labs:
  • Total serum bilirubin >1.5 times the upper limit of normal (ULN) (>3 × ULN for patients with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN (>5 × ULN if liver function abnormalities are due to hepatic metastasis).
  • Albumin <2.8 g/dL
  • Absolute neutrophil count < 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 values at screening).
  • Known or suspected brain metastasis or active leptomeningeal disease.
  • Symptomatic or impending spinal cord compression or cauda equina syndrome.
  • Any history of myelodysplastic syndrome, acute myeloid leukemia, or prior malignancy except any of the following:
  • Carcinoma in situ or non melanoma skin cancer
  • Any prior malignancies ≥3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage.
  • Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence or progression in the opinion of the investigator
  • Gastrointestinal disorder affecting absorption.
  • Fertile male subjects who are unwilling or unable to use highly effective methods of contraception for the duration of the study and for 4 months after the last dose of investigational product.
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Other acute or chronic medical (concurrent disease, infection, or comorbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that interferes with ability to participate in the study, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of randomization (Part 2).

Trial locations and contacts

370 sites in 26 countries.

370 sites in 26 countries

United States132 sites

  • Urology Group of New Mexico

    Albuquerque, New Mexico, 87109

  • Florida Cancer Specialists

    Altamonte Springs, Florida, 32701

  • UPMC Hillman Cancer Center - Altoona

    Altoona, Pennsylvania, 16601

  • Alaska Urological Institute dba Alaska Clinical Research Center

    Anchorage, Alaska, 99503

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

  • University of Colorado Denver CTO/CTRC

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • University of Colorado Hospital- Anschutz Inpatient Pavilion

    Aurora, Colorado, 80045

  • University of Colorado Hospital- Anschutz Outpatient Pavilion

    Aurora, Colorado, 80045

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Urology Austin PLLC

    Austin, Texas, 78745

  • Clara Maass Medical Center

    Belleville, New Jersey, 07109

  • New Jersey Cancer Care and Blood Disorders

    Belleville, New Jersey, 07109

  • UPMC Hillman Cancer Center - Upper St. Clair

    Bethel Park, Pennsylvania, 15102

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Florida Cancer Specialists

    Brandon, Florida, 33511

  • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

  • Tennessee Oncology PLLC

    Chattanooga, Tennessee, 37404

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee, 37404

  • Cook County Health (CCH)

    Chicago, Illinois, 60612

  • John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy

    Chicago, Illinois, 60612

  • South County Hematology/Oncology

    Chula Vista, California, 91911

  • Sharp Rees-Stealy

    Chula Vista, California, 91913

  • TriState urologic Services PSC Inc., dba The Urology Group

    Cincinnati, Ohio, 45212

  • Kaiser Sunnyside Medical Center

    Clackamas, Oregon, 97015

  • Florida Cancer Specialists

    Clearwater, Florida, 33761

  • Florida Cancer Specialists

    Daytona Beach, Florida, 32117

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Rio Grande Urology, P.A.

    El Paso, Texas, 79912

  • Inova Schar Cancer Institute Infusion Pharmacy

    Fairfax, Virginia, 22031

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • The University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Farmington Health Center -University of Utah

    Farmington, Utah, 84025

  • Piedmont Cancer Institute

    Fayetteville, Georgia, 30214

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

  • Florida Cancer Specialists

    Gainesville, Florida, 32605

  • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

    Gilbert, Arizona, 85297

  • Glendale Adventist Medical Center

    Glendale, California, 91206

  • Marin Cancer Care, Inc.

    Greenbrae, California, 94904

  • UPMC Hillman Cancer Center - Arnold Palmer - Mt View

    Greensburg, Pennsylvania, 15601

  • Kaiser Westside Medical Center

    Hillsboro, Oregon, 97124

  • AMITA Health Adventist Medical Center Hinsdale

    Hinsdale, Illinois, 60521

  • AMITA Health Cancer Institute

    Hinsdale, Illinois, 60521

  • Houston Metro Urology

    Houston, Texas, 77027

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • Clark Memorial Hospital Radiology

    Jeffersonville, Indiana, 47130

  • First Urology, PSC

    Jeffersonville, Indiana, 47130

  • Cancer Center Oncology Medical Group

    La Mesa, California, 91942

  • Lakeland Regional Health Hollis Cancer Center

    Lakeland, Florida, 33805

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604

  • Florida Cancer Specialists

    Largo, Florida, 33770

  • Florida Cancer Specialists

    Lecanto, Florida, 34461

  • Loma Linda University Cancer Center - Records Management Only

    Loma Linda, California, 92350

  • Loma Linda University Cancer Center - Hematology/Oncology Clinic

    Loma Linda, California, 92354

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • UCLA Clark Urology Center

    Los Angeles, California, 90095

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792

  • University of Wisconsin Hospital & Clinics

    Madison, Wisconsin, 53792

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

    Mesa, Arizona, 85202

  • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

    Mesa, Arizona, 85206

  • Clinical Research Solutions

    Middleburg Heights, Ohio, 44130

  • UPMC Hillman Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates P.C.

    Nashville, Tennessee, 37209

  • The Vanderbilt Clinic

    Nashville, Tennessee, 37232

  • Vanderbuilt University Medical Center, Department of Urology

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Florida Cancer Specialists

    New Port Richey, Florida, 34655

  • Providence Cancer Institute Newberg Clinic

    Newberg, Oregon, 97132

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Piedmont Cancer Institute

    Newnan, Georgia, 30265

  • Southeastern Regional Medical Center

    Newnan, Georgia, 30265

  • University Radiology

    Nutley, New Jersey, 07110

  • Florida Cancer Specialists

    Ocala, Florida, 34471

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • XCancer Omaha / Urology Cancer Center, PC d/b/a XCancer

    Omaha, Nebraska, 68130

  • University of California, Irvine Medical Center

    Orange, California, 92868

  • Florida Cancer Specialists

    Orange City, Florida, 32763

  • Providence Cancer Institute Willamette Falls

    Oregon City, Oregon, 97045

  • AdventHealth Medical Group Hermatology and Oncology

    Orlando, Florida, 32804

  • Investigational Drug Services, Advent Health Orlando

    Orlando, Florida, 32804

  • Florida Cancer Specialists

    Orlando, Florida, 32806

  • Stanford Cancer Institute

    Palo Alto, California, 94304

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC Hillman Cancer Center - Passavant (HOA)

    Pittsburgh, Pennsylvania, 15237

  • UPMC Hillman Cancer Center - Passavant (OHA)

    Pittsburgh, Pennsylvania, 15237

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Oncology and Hematology Care Clinic - Westside

    Portland, Oregon, 97225

  • Providence St Vincent Medical Center - Investigational Drug Service

    Portland, Oregon, 97225

  • Providence St Vincent Medical Center

    Portland, Oregon, 97225

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Premier Medical Group of the Hudson Valley PC

    Poughkeepsie, New York, 12603

  • Desert Hematology Oncology Medical Group, Incorporation

    Rancho Mirage, California, 92270

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • Urology Austin, PLLC

    Round Rock, Texas, 78681

  • Huntsman Cancer Hospital

    Salt Lake City, Utah, 84112

  • University of Utah, Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Redwood Health Center-University of Utah

    Salt Lake City, Utah, 84119

  • Medical Oncology Associates-SD

    San Diego, California, 92123

  • Sharp Memorial Hospital Investigational Pharmacy

    San Diego, California, 92123

  • Sharp Rees-Stealy

    San Diego, California, 92123

  • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

    Scottsdale, Arizona, 85260

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Swedish Medical Center

    Seattle, Washington, 98122

  • UPMC Hillman Cancer Center - Northwest

    Seneca, Pennsylvania, 16346

  • South Jordan Health Center -University of Utah

    South Jordan, Utah, 84095

  • Florida Cancer Specialists

    Spring Hill, Florida, 34608

  • VA Saint Louis Healthcare System

    St Louis, Missouri, 63106

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Stanford Health Care

    Stanford, California, 94305

  • Florida Cancer Specialists

    Stuart, Florida, 34994

  • Associated Medical Professionals of New York, PLLC

    Syracuse, New York, 13210

  • Florida Cancer Specialists

    Tampa, Florida, 33607

  • Florida Cancer Specialists

    Tavares, Florida, 32778

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas, 76508

  • Montefiore Medical Center - Montefiore Medical Park

    The Bronx, New York, 10461

  • Florida Cancer Specialists

    The Villages, Florida, 32159

  • Arizona Urology Specialists

    Tucson, Arizona, 85715

  • Arizona Urology Specialists

    Tucson, Arizona, 85741

  • UPMC Hillman Cancer Center - Uniontown

    Uniontown, Pennsylvania, 15401

  • Florida Cancer Specialists

    Vero Beach, Florida, 32960

  • New Jersey Urology, LLC

    Voorhees Township, New Jersey, 08043

  • UPMC Hillman Cancer Center - Washington

    Washington, Pennsylvania, 15301

  • Florida Cancer Specialists

    Wellington, Florida, 33414

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Florida Cancer Specialists

    Winter Park, Florida, 32792

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

China35 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing Hospital

    Beijing, 100010

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

  • Peking University First Hospital / Urology Department

    Beijing, 100034

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • The First affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222500

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210012

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226000

  • The first affiliated hospital of Ningbo university

    Ningbo, Zhejiang, 315010

  • Urinary surgery, Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

  • Fudan University Cancer Hospital, Deptartment of Urology

    Shanghai, 200032

  • Shanghai Tenth People's Hospital

    Shanghai, 200072

  • The Fifth People's Hospital of Shanghai, Fudan University

    Shanghai, 201100

  • Second Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu

  • The Second Hospital of Tianjin Medical University

    Tianjin, 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

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

Other trials in China

Japan23 sites

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hamamatsu University School of Medicine, 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

  • Osaka University Hospital

    Suita, Osaka, 565-0871

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Yamagata Prefectural Central Hospital

    Yamagata, 990-2292

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa, 238-8558

Other trials in Japan

Brazil20 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Associacao Hospital de Caridade de Ijui

    Ijuí, Rio Grande do Sul, 98700-000

  • Sociedade Beneficencia e Caridade de Lajeado - Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-022

  • Centro de Pesquisa Clinica em Oncologia - Hospital Sao Lucas da Pontificia Universidade Catolica

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Centro Gaucho Integrado - Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90850-170

  • MedPlex Eixo Norte

    Porto Alegre, Rio Grande do Sul, 91010-004

  • Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA

    Rio de Janeiro, Rio de Janeiro, 20230-130

  • Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA

    Rio de Janeiro, Rio de Janeiro, 20231-050

  • Hospital Universitario Pedro Ernesto-Centro de Pesquisas (CEPUSA)

    Rio de Janeiro, Rio de Janeiro, 20551-030

  • Hospital CopaDor

    Rio de Janeiro, Rio de Janeiro, 22031-011

  • Hospital Gloria D'Or

    Rio de Janeiro, Rio de Janeiro, 22211-230

  • Oncologia D'Or

    Rio de Janeiro, Rio de Janeiro, 22251-040

  • Instituto D'Or de Pesquisa e Ensino

    Rio de Janeiro, Rio de Janeiro, 22281-100

  • Oncologia D'Or

    Rio de Janeiro, Rio de Janeiro, 22291-110

  • Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa de Hematologia e Oncologia (CEPHO)

    Santo André, São Paulo, 09060-650

  • Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia (CEPHO)

    Santo André, São Paulo, 09060-870

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Hospital Alemão Oswaldo Cruz

    São Paulo, São Paulo, 01327-001

  • Instituto do Cancer do Estado de Sao Paulo-ICESP-Nucleo de Pesquisa

    São Paulo, SÃO Paulo (SP), 01246-000

Other trials in Brazil

France15 sites

  • Centre d'Oncologie du Pays-Basque

    Bayonne, 64100

  • Clinique Ramsay Belharra

    Bayonne, 64100

  • Hopital Saint Andre - CHU de Bordeaux

    Bordeaux, 33075

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • Clinique Victor Hugo Le Mans

    Le Mans, Pays de la Loire Region, 72000

  • Centre Leon Berard

    Lyon, 69373

  • Centre Léon Bérard

    Lyon, 69373

  • CHU Montpellier-Hopital Saint Eloi

    Montpellier, 34295

  • Hopital Saint-Louis

    Paris, 75010

  • Hopital Europeen Georges Pompidou

    Paris, 75908

  • Clinique Sainte Anne

    Strasbourg, 67000

  • Hopitaux Universitaires de Strasbourg - ICANS

    Strasbourg, 67200

  • Hopital Foch

    Suresnes, 92150

  • Hopital Foch

    Suresnes, 92151

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Australia13 sites

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066

  • River City Pharmacy

    Auchenflower, Queensland, 4066

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • ICON Cancer Centre Chermside

    Chermside, Queensland, 4032

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Peter MacCallum Cancer Centre

    North Melbourne, Victoria, 3051

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, 2444

  • ICON Cancer Centre South Brisbane

    South Brisbane, Queensland, 4101

  • Integrated Clinical Oncology Network Pty Ltd (ICON)

    South Brisbane, Queensland, 4101

  • ICON Cancer Centre Southport

    Southport, Queensland, 4215

Other trials in Australia

South Korea13 sites

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Clinical Trial Pharmacy, National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Seoul National University Hospital

    Seoul, 03080

  • Clinical Trial Center, Serverance Hospital, yonsei University Health System

    Seoul, 03722

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Cancer Center Clinical Trial, Asan Medical Center

    Seoul, 05505

  • Clinical Trials Center Pharmacy

    Seoul, 06351

  • Samsung Medical Center

    Seoul, 06351

  • Clinical Trial Pharmacy, The Catholic University of Korea

    Seoul, 06591

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

    Seoul, 06591

Other trials in South Korea

United Kingdom13 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Wirral, CH63 4JY

  • Royal Cornwall Hospitals NHS Trust

    Cornwall, TR1 3LJ

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

    Glasgow, Scotland, G12 0XH

  • NHS Greater Glasgow and Clyde

    Glasgow, Scotland, G12 0XH

  • NHS Greater Glasgow and Clyde (Radiology/Scans Address)

    Glasgow, G12 0YN

  • NHS Greater Glasgow and Clyde, The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • The Clatterbridge Cancer Centre - Liverpool

    Liverpool, L7 8YA

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

  • Imperial College Healthcare NHS Trust

    London, W2 1NY

  • Imperial College Healthcare NHS Trust, Charing Cross Hospital

    London, W6 8RF

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire, OX3 9DU

  • Department of Oncology, Cancer and Haematology Centre, Churchill Hospital

    Oxford, OX3 7LE

  • University Hospitals Plymouth NHS Trust

    Plymouth, Devon, PL6 8DH

Other trials in United Kingdom

Spain11 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Institut Catala d'Oncologia - ICO L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

  • Corporacio Sanitaria i Universitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruna, 15706

Other trials in Spain

Canada8 sites

  • Arthur J.E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

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

    Chicoutimi, Quebec, G7H 5H6

  • Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 7K9

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 0A9

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • The Ottawa Hospital Cancer Center

    Ottawa, Ontario, K1H 8L6

  • Centre integre universitaire de sante et de services sociaux de l'Estrie

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Italy8 sites

  • Azienda Ospedaliero-Universitaria Policlinico Sant' Orsola Malpighi

    Bologna, BO, 40138

  • ASST di Cremona

    Cremona, CR, 26100

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

    Meldola, FC, 47014

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli

    Naples, 80131

  • AOU San Luigi Gonzaga

    Orbassano, TO, 10043

  • Azienda Ospedaliera S. Maria

    Terni, TN, 05100

  • Ospedale Santa Chiara

    Trento, TN, 38122

  • Azienda sanitaria universitaria integrata del Trentino (ASUIT) - Ospedale Santa Chiara

    Trento, Trentino-Alto Adige, 38122

Other trials in Italy

Finland7 sites

  • HUS Helsinki University Hospital

    Helsinki, 00029

  • Docrates Cancer Center

    Helsinki, 00180

  • Kuopio University Hospital

    Kuopio, 70210

  • Oulun yliopistollinen sairaala

    Oulu, 90220

  • Pirkanmaan hyvinvointialue

    Tampere, 33520

  • Tampere University Hospital

    Tampere, 33520

  • Turku University Hospital

    Turku, 20520

Other trials in Finland

Germany7 sites

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitaetsklinik Heidelberg

    Heidelberg, 69120

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

  • Diagnostikzentrum

    Kirchheim, 73230

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Studienpraxis Urologie

    Nürtingen, 72622

Other trials in Germany

Argentina6 sites

  • Hospital Británico de Buenos Aires

    Caba, C1280AEB

  • Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" Cemic

    Caba, C1431FWO

  • Clinica Universitaria Reina Fabiola

    Córdoba, X5004FHP

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Centro de Investigacion Pergamino SA - Clinica Pergamino SA

    Pergamino, Buenos Aires, B2700CPM

  • Instituto de Oncologia de Rosario

    Rosario, Santa Fe Province, S2000KZE

Other trials in Argentina

Belgium6 sites

  • AZ Klina

    Brasschaat, 2930

  • A.Z. Sint-Lucas

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • AZ Groeninge

    Kortrijk, 8500

  • Clinique Saint-Pierre Ottignies

    Ottignies, 1340

  • CHU UCL Namur site Godinne

    Yvoir, 5530

Other trials in Belgium

Hungary6 sites

  • Semmelweis Egyetem Urologiai Klinika

    Budapest, 1082

  • Országos Onkológiai Intézet

    Budapest, 1122

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Uzsoki Utcai Kórház

    Budapest, 1145

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intezet

    Pécs, 7624

Other trials in Hungary

Norway6 sites

  • Sykehusapoteket Ostfold, Kalnes

    Grålum, 1712

  • Ostfold County Hospital, Kalnes

    Grålum, 1714

  • Akershus University Hospital

    Lorenskog, 1478

  • Oslo University Hospital -Ullevål & Radiumhospitalet

    Oslo, 0379

  • St. Olavs Hospital, Trondheim University Hospital

    Trondheim, 7030

  • Trondheim Hospital Pharmacy

    Trondheim, 7030

Other trials in Norway

Poland6 sites

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza

    Brzozów, 36-200

  • Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii

    Gdynia, 81-519

  • Przychodnia Lekarska "Komed" Roman Karaszewski

    Konin, 62-500

  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina

    Otwock, 05-400

  • City Clinic Sp. z o.o.

    Warsaw, 02-473

  • NZOZ Szpital Mazovia; Oddzial urologiczny

    Warsaw, 02-797

Other trials in Poland

Portugal6 sites

  • Centro Clínico Académico - Braga, Associação (2CABraga)

    Braga, 4710-243

  • Instituto Português Oncologia de Coimbra Francisco Gentil - E.P.E

    Coimbra, 3000-075

  • Fundação Champalimaud

    Lisbon, 1400-038

  • Hospital da Luz Lisboa

    Lisbon, 1500-650

  • Centro Hospitalar do Porto - Hospital de Santo Antonio

    Porto, 4099-001

  • Instituto Português de Oncologia do Porto Francisco Gentil

    Porto, 4200-072

Other trials in Portugal

South Africa6 sites

  • Cancercare Rondebosch Oncology

    Cape Town, Western Cape, 7700

  • Outeniqua Cancercare Oncology Unit

    George, Western Cape, 6530

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

  • Cape Town Oncology Trials

    Kraaifontein, Western Cape, 7570

  • Wits Clinical Research

    Parktown, Gauteng, 2193

  • Cancercare Langenhoven Drive Oncology Centre

    Port Elizabeth, Eastern Cape, 6045

Other trials in South Africa

Chile5 sites

  • James Lind Centro de Investigación del Cáncer

    Araucania, 4800827

  • Sociedad Prosalud Montes y Orlandi Ltda. Fantasy name (Orlandi Oncologia)

    Santiago, Santiago Metropolitan, 7500713

  • Centro de Investigacion Clinica del Sur

    Temuco, Araucania, 4781156

  • Centro de Investigaciones Clinicas Vina del Mar

    Viña del Mar, Valparaiso, 2540488

  • Centro de Investigaciones Clinicas Vina del Mar

    Viña del Mar, Valparaiso, 2540634

Other trials in Chile

Czechia4 sites

  • Fakultní nemocnice Hradec Králové

    Hradec Králové, 500 05

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

  • Multiscan s.r.o.

    Pardubice, 532 03

  • Fakultní nemocnice Královské Vinohrady

    Prague, 100 34

Other trials in Czechia

New Zealand4 sites

  • Auckland City Hospital

    Auckland, 1023

  • Canterbury District Health Board

    Christchurch, Canterbury, 8011

  • Waikato Hospital

    Hamilton, Waikato Region, 3204

  • Tauranga Urology Research Limited

    Tauranga, Bay of Plenty, 3112

Other trials in New Zealand

Peru4 sites

  • Clinica Monte Carmelo S.C.R.LTDA.

    Arequipa

  • Hospital Militar Central "Coronel Luis Arias Schreiber"

    Lima, Lima 11

  • Clinica Internacional Sede San Borja

    Lima, Lima 41

  • Clinica Oncosalud

    Lima, Lima 41

Other trials in Peru

Israel3 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Västra Götalands LÄN [se-14], 413 45

  • Karolinska Universitetssjukhuset

    Solna, 17176

  • Cancercentrum

    Umeå, 901 85

Other trials in Sweden

About this study

Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.

Read the detailed description

Part 1 is an open-label, non-randomized, safety and PK run-in study designed to confirm the starting dose of talazoparib in combination with enzalutamide through assessment of target safety events and PK at select sites. Part 2 is a randomized, double-blind, placebo-controlled, multinational study comparing talazoparib plus enzalutamide vs. placebo plus enzalutamide in patients with mCRPC.

Conditions
mCRPC
Being tested
Talazoparib with enzalutamide, Placebo with enzalutamide
Keywords
mCRPC (metastatic castration-resistant prostate cancer)

What participants receive

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

  • Talazoparib with enzalutamideDrug

    Talazoparib 0.5 mg/day plus enzalutamide 160mg/day

  • Placebo with enzalutamideDrug

    Placebo plus enzalutamide 160 mg/day

Study groups in NCT03395197
Study groupRoleWhat they receive
Combination armExperimentalTalazoparib plus enzalutamide
Receives: Drug: Talazoparib with enzalutamide
Monotherapy armActive comparatorEzalutamide plus placebo
Receives: Drug: Placebo with enzalutamide

What is being measured

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

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1

    An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per Common Terminology Criteria for Adverse Events (CTCAE) version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. Serious TEAE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.

    Measured: Post dose on Day 1 up to Day 66 in Part 1

  2. Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1

    An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1=mild AE; Grade 2=moderate AE; Grade 3=severe AE; Grade 4=life-threatening or disabling AE; Grade 5=death related to an AE. Medical Dictionary for Regulatory Activities (MedDRA) v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with at least 1 occurrence in participants are reported for this outcome measure. Results as of 16 Aug 2022 are reported.

    Measured: Post dose on Day 1 up to Day 66 in Part 1

  3. Number of Participants With All-Causality TEAEs During the Overall Period of Part 1

    An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. Serious TEAE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.

    Measured: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)

  4. Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1

    An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.

    Measured: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)

  5. Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1

    An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1=mild AE; Grade 2=moderate AE; Grade 3=severe AE; Grade 4=life-threatening or disabling AE; Grade 5=death related to an AE. MedDRA v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with at least 1 occurrence in participants are reported for this outcome measure. Results as of 16 Aug 2022 are reported.

    Measured: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)

  6. Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1

    An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are newly occurring AEs or those worsening after first dose. Treatment-related AE was any AE attributed to study intervention in a participant who received study intervention. As per CTCAE version 4, Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling; Grade 5=death related to an AE. MedDRA v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with incidence in >=10% of participants are reported. Results as of 16 Aug 2022 are reported.

    Measured: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)

  7. Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1

    rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by computed tomography (CT) of chest and CT or magnetic resonance imaging (MRI) of abdomen and pelvis. Progression is defined using RECIST 1.1 as a >=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Results as of 16 Aug 2022 are reported for this outcome measure.

    Measured: From the start of treatment to the time of first documented progression, or death (maximum up to 42 months)

  8. BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2

    rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by CT of chest and CT or MRI of abdomen and pelvis. Results as of 03 Oct 2022 are reported for this outcome measure.

    Measured: From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)

Timeline

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

  1. First posted10 Jan 2018
  2. Study start18 Dec 2017
  3. Primary completion3 Oct 2022
  4. Study completion30 Jun 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
To assess radiographic PFS in men with mCRPC (with no systemic treatments initiated after documentation of mCRCP) treated with talazoparib and enzalutamide vs. placebo plus enzalutamide
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,054 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03395197
Sponsor's protocol ID
C3441021
Other IDs
2017-003295-31, TALAPRO-2, 2023-509087-20-00, 2023, 2017
Acronym
TALAPRO-2
Status last verified
Oct 2026
First submitted
21 Nov 2017
Last updated
14 Oct 2026
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

  • Yajima S, Yoshida S, Chen W, Fukushima H, Tanaka H, Sato H, Hirakawa A, Masuda H, Fujii Y. Exploratory Time-Dependent Patterns in Estimated Treatment Effect of Talazoparib Plus Enzalutamide in HRR Non-Deficient or Unknown Metastatic Castration-Resistant Prostate Cancer: A Post Hoc Analysis of the TALAPRO-2 Trial. Int J Urol. 2026 Jul;33(7):e70582. doi: 10.1111/iju.70582.

    PubMed 42502892

  • Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Szczylik C, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Saad F, Dunshee C, Zschabitz S, Oldenburg J, Lin X, Healy CG, Kalac M, Kennedy D, Fizazi K. A plain language summary of the final overall survival results from the TALAPRO-2 study comparing talazoparib plus enzalutamide with placebo plus enzalutamide for patients with advanced prostate cancer. Future Oncol. 2026 Jun;22(14):1687-1702. doi: 10.1080/14796694.2026.2668552. Epub 2026 Jun 9.

    PubMed 42261883

  • Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschabitz S, Oldenburg J, Ye D, Lin X, Kalac M, Laird AD, Kennedy D, Agarwal N. A plain language summary of the final overall survival results from the TALAPRO-2 study comparing talazoparib plus enzalutamide versus placebo plus enzalutamide for patients with advanced prostate cancer and changes in specific DNA repair genes. Future Oncol. 2026 Jun;22(14):1669-1685. doi: 10.1080/14796694.2026.2661093. Epub 2026 Jun 4.

    PubMed 42237765

  • Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Szczylik C, De Giorgi U, Young Joung J, Fong PCC, Voog E, Jones RJ, Shore ND, Saad F, Dunshee C, Zschabitz S, Oldenburg J, Lin X, Healy CG, Kalac M, Kennedy D, Fizazi K. Talazoparib plus enzalutamide in men with metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet. 2025 Aug 2;406(10502):447-460. doi: 10.1016/S0140-6736(25)00684-1. Epub 2025 Jul 16.

    PubMed 40683290

  • Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Young Joung J, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschabitz S, Oldenburg J, Ye D, Lin X, Kalac M, Douglas Laird A, Kennedy D, Agarwal N. Talazoparib plus enzalutamide in men with HRR-deficient metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet. 2025 Aug 2;406(10502):461-474. doi: 10.1016/S0140-6736(25)00683-X. Epub 2025 Jul 16.

    PubMed 40683287

  • Fay AP, Fizazi K, Matsubara N, Azad AA, Saad F, De Giorgi U, Joung JY, Fong PCC, Jones RJ, Zschabitz S, Oldenburg J, Shore ND, Dunshee C, Carles J, Cislo P, Chang J, Healy CG, Niyazov A, Agarwal N. First-line talazoparib plus enzalutamide versus placebo plus enzalutamide in men with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: patient-reported outcomes from the randomised, double-blind, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet Oncol. 2025 Apr;26(4):481-490. doi: 10.1016/S1470-2045(25)00031-2.

    PubMed 40179907

  • Matsubara N, Azad AA, Agarwal N, Saad F, De Giorgi U, Joung JY, Fong PCC, Jones RJ, Zschabitz S, Oldenburg J, Shore ND, Dunshee C, Carles J, Fay AP, Cislo P, Chang J, Healy CG, Niyazov A, Fizazi K. First-line talazoparib plus enzalutamide versus placebo plus enzalutamide for metastatic castration-resistant prostate cancer: patient-reported outcomes from the randomised, double-blind, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet Oncol. 2025 Apr;26(4):470-480. doi: 10.1016/S1470-2045(25)00030-0.

    PubMed 40179906

  • Matsubara N, Miyake H, Uemura H, Mizokami A, Kikukawa H, Kosaka T, Nishimura K, Nakamura M, Kobayashi K, Komaru A, Mori Y, Toyoizumi S, Hori N, Umeyama Y, Uemura H. Phase 3 Study of Talazoparib Plus Enzalutamide Versus Placebo Plus Enzalutamide as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer: TALAPRO-2 Japanese Subgroup Analysis. Cancer Med. 2025 Jan;14(1):e70333. doi: 10.1002/cam4.70333.

    PubMed 39737542

  • Azad AA, Fizazi K, Matsubara N, Saad F, De Giorgi U, Joung JY, Fong PCC, Jones RJ, Zschabitz S, Oldenburg J, Shore ND, Dunshee C, Carles J, Fay AP, Lin X, DeAnnuntis L, Di Santo N, Zielinski MA, Agarwal N. Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: Safety analyses from the randomized, placebo-controlled, phase III TALAPRO-2 study. Eur J Cancer. 2024 Dec;213:115078. doi: 10.1016/j.ejca.2024.115078. Epub 2024 Oct 20.

    PubMed 39486165

  • Agarwal N, Saad F, Azad AA, Mateo J, Matsubara N, Shore ND, Chakrabarti J, Chen HC, Lanzalone S, Niyazov A, Fizazi K. The TALAPRO-3 study design: a plain language summary. Future Oncol. 2024;20(30):2225-2231. doi: 10.1080/14796694.2024.2363131. Epub 2024 Jul 24.

    PubMed 39451095

  • Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Heinrich D, Szczylik C, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschabitz S, Oldenburg J, Lin X, Healy CG, Di Santo N, Zohren F, Fizazi K. Plain language summary of the results from the TALAPRO-2 study: Talazoparib plus enzalutamide versus placebo plus enzalutamide for patients with advanced prostate cancer. Future Oncol. 2024;20(29):2123-2135. doi: 10.1080/14796694.2024.2362108. Epub 2024 Jul 12.

    PubMed 38995237

  • Heiss BL, Chang E, Gao X, Truong T, Brave MH, Bloomquist E, Shah A, Hamed S, Kraft J, Chiu HJ, Ricks TK, Tilley A, Pierce WF, Tang L, Abukhdeir A, Kalavar S, Philip R, Tang S, Pazdur R, Amiri-Kordestani L, Kluetz PG, Suzman DL. US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2024 May 20;42(15):1851-1860. doi: 10.1200/JCO.23.02182. Epub 2024 Mar 7.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Talazoparib with enzalutamide in people with mCRPC, run by Pfizer at 370 sites in 26 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 18 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 370 sites in United States, China, Japan, Brazil, France and 21 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?

Yes. Results are posted in the registry (first posted 17 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1 (time frame: Post dose on Day 1 up to Day 66 in Part 1). The study lists 8 primary outcomes in all. 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 NCT03395197, which also lists 15 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 14 Oct 2026.

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