Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
NCT ID: NCT03395197
Last Updated: 2025-12-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1054 participants
INTERVENTIONAL
2017-12-18
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Combination arm
Talazoparib plus enzalutamide
Talazoparib with enzalutamide
Talazoparib 0.5 mg/day plus enzalutamide 160mg/day
Monotherapy arm
Ezalutamide plus placebo
Placebo with enzalutamide
Placebo plus enzalutamide 160 mg/day
Interventions
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Talazoparib with enzalutamide
Talazoparib 0.5 mg/day plus enzalutamide 160mg/day
Placebo with enzalutamide
Placebo plus enzalutamide 160 mg/day
Eligibility Criteria
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Inclusion Criteria
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.
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
Exclusion Criteria
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).
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).
18 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
Gilbert, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
Scottsdale, Arizona, United States
Arizona Urology Specialists
Tucson, Arizona, United States
Arizona Urology Specialists
Tucson, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
South County Hematology/Oncology
Chula Vista, California, United States
Sharp Rees-Stealy
Chula Vista, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Marin Cancer Care, Inc.
Greenbrae, California, United States
Cancer Center Oncology Medical Group
La Mesa, California, United States
Loma Linda University Cancer Center - Records Management Only
Loma Linda, California, United States
Loma Linda University Cancer Center - Hematology/Oncology Clinic
Loma Linda, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
VA Long Beach Healthcare System
Long Beach, California, United States
UCLA Clark Urology Center
Los Angeles, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Desert Hematology Oncology Medical Group, Incorporation
Rancho Mirage, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Medical Oncology Associates-SD
San Diego, California, United States
Sharp Memorial Hospital Investigational Pharmacy
San Diego, California, United States
Sharp Rees-Stealy
San Diego, California, United States
Stanford Health Care
Stanford, California, United States
University of Colorado Denver CTO/CTRC
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
University of Colorado Hospital- Anschutz Inpatient Pavilion
Aurora, Colorado, United States
University of Colorado Hospital- Anschutz Outpatient Pavilion
Aurora, Colorado, United States
University of Colorado Hospital
Aurora, Colorado, United States
The Urology Center of Colorado
Denver, Colorado, United States
Florida Cancer Specialists
Altamonte Springs, Florida, United States
Florida Cancer Specialists
Brandon, Florida, United States
Florida Cancer Specialists
Clearwater, Florida, United States
Florida Cancer Specialists
Daytona Beach, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Gainesville, Florida, United States
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, United States
Florida Cancer Specialists
Largo, Florida, United States
Florida Cancer Specialists
Lecanto, Florida, United States
Florida Cancer Specialists
New Port Richey, Florida, United States
Florida Cancer Specialists
Ocala, Florida, United States
Florida Cancer Specialists
Orange City, Florida, United States
AdventHealth Medical Group Hermatology and Oncology
Orlando, Florida, United States
Investigational Drug Services, Advent Health Orlando
Orlando, Florida, United States
Florida Cancer Specialists
Orlando, Florida, United States
Florida Cancer Specialists
Spring Hill, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Florida Cancer Specialists
Stuart, Florida, United States
Florida Cancer Specialists
Tampa, Florida, United States
Florida Cancer Specialists
Tavares, Florida, United States
Florida Cancer Specialists
The Villages, Florida, United States
Florida Cancer Specialists
Vero Beach, Florida, United States
Florida Cancer Specialists
Wellington, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Florida Cancer Specialists
Winter Park, Florida, United States
Piedmont Cancer Institute
Atlanta, Georgia, United States
Piedmont Cancer Institute
Fayetteville, Georgia, United States
Piedmont Cancer Institute
Newnan, Georgia, United States
Southeastern Regional Medical Center
Newnan, Georgia, United States
Cook County Health (CCH)
Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
Chicago, Illinois, United States
AMITA Health Adventist Medical Center Hinsdale
Hinsdale, Illinois, United States
AMITA Health Cancer Institute
Hinsdale, Illinois, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
Clark Memorial Hospital Radiology
Jeffersonville, Indiana, United States
First Urology, PSC
Jeffersonville, Indiana, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
VA Saint Louis Healthcare System
St Louis, Missouri, United States
XCancer Omaha / Urology Cancer Center, PC d/b/a XCancer
Omaha, Nebraska, United States
Clara Maass Medical Center
Belleville, New Jersey, United States
New Jersey Cancer Care and Blood Disorders
Belleville, New Jersey, United States
University Radiology
Nutley, New Jersey, United States
New Jersey Urology, LLC
Voorhees Township, New Jersey, United States
Urology Group of New Mexico
Albuquerque, New Mexico, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, United States
Associated Medical Professionals of New York, PLLC
Syracuse, New York, United States
Montefiore Medical Center - Montefiore Medical Park
The Bronx, New York, United States
TriState urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, United States
Clinical Research Solutions
Middleburg Heights, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Kaiser Sunnyside Medical Center
Clackamas, Oregon, United States
Kaiser Westside Medical Center
Hillsboro, Oregon, United States
Providence Cancer Institute Newberg Clinic
Newberg, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Cancer Institute Willamette Falls
Oregon City, Oregon, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic - Westside
Portland, Oregon, United States
Providence St Vincent Medical Center - Investigational Drug Service
Portland, Oregon, United States
Providence St Vincent Medical Center
Portland, Oregon, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
UPMC Hillman Cancer Center - Altoona
Altoona, Pennsylvania, United States
UPMC Hillman Cancer Center - Upper St. Clair
Bethel Park, Pennsylvania, United States
UPMC Hillman Cancer Center - Arnold Palmer - Mt View
Greensburg, Pennsylvania, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center - Passavant (HOA)
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center - Passavant (OHA)
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center - Northwest
Seneca, Pennsylvania, United States
UPMC Hillman Cancer Center - Uniontown
Uniontown, Pennsylvania, United States
UPMC Hillman Cancer Center - Washington
Washington, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Tennessee Oncology PLLC - Greco-Hainesworth Centers for Research
Chattanooga, Tennessee, United States
Urology Associates P.C.
Nashville, Tennessee, United States
The Vanderbilt Clinic
Nashville, Tennessee, United States
Vanderbuilt University Medical Center, Department of Urology
Nashville, Tennessee, United States
Urology Austin PLLC
Austin, Texas, United States
Rio Grande Urology, P.A.
El Paso, Texas, United States
Houston Metro Urology
Houston, Texas, United States
Urology Austin, PLLC
Round Rock, Texas, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, United States
Farmington Health Center -University of Utah
Farmington, Utah, United States
Huntsman Cancer Hospital
Salt Lake City, Utah, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
Redwood Health Center-University of Utah
Salt Lake City, Utah, United States
South Jordan Health Center -University of Utah
South Jordan, Utah, United States
Inova Schar Cancer Institute Infusion Pharmacy
Fairfax, Virginia, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
Centro de Investigacion Pergamino SA - Clinica Pergamino SA
Pergamino, Buenos Aires, Argentina
Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, Argentina
Hospital Británico de Buenos Aires
Caba, , Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" Cemic
Caba, , Argentina
Clinica Universitaria Reina Fabiola
Córdoba, , Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, , Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia
River City Pharmacy
Auchenflower, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
ICON Cancer Centre Chermside
Chermside, Queensland, Australia
ICON Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
Integrated Clinical Oncology Network Pty Ltd (ICON)
South Brisbane, Queensland, Australia
ICON Cancer Centre Southport
Southport, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre
North Melbourne, Victoria, Australia
AZ Klina
Brasschaat, , Belgium
A.Z. Sint-Lucas
Ghent, , Belgium
UZ Gent
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
Clinique Saint-Pierre Ottignies
Ottignies, , Belgium
CHU UCL Namur site Godinne
Yvoir, , Belgium
Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA
Rio de Janeiro, Rio de Janeiro, Brazil
Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Universitario Pedro Ernesto-Centro de Pesquisas (CEPUSA)
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital CopaDor
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Gloria D'Or
Rio de Janeiro, Rio de Janeiro, Brazil
Oncologia D'Or
Rio de Janeiro, Rio de Janeiro, Brazil
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, Rio de Janeiro, Brazil
Oncologia D'Or
Rio de Janeiro, Rio de Janeiro, Brazil
Associacao Hospital de Caridade de Ijui
Ijuí, Rio Grande do Sul, Brazil
Sociedade Beneficencia e Caridade de Lajeado - Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Centro de Pesquisa Clinica em Oncologia - Hospital Sao Lucas da Pontificia Universidade Catolica
Porto Alegre, Rio Grande do Sul, Brazil
Centro Gaucho Integrado - Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil
MedPlex Eixo Norte
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa de Hematologia e Oncologia (CEPHO)
Santo André, São Paulo, Brazil
Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia (CEPHO)
Santo André, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo-ICESP-Nucleo de Pesquisa
São Paulo, SÃO Paulo (SP), Brazil
Arthur J.E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
The Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada
Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre integre universitaire de sante et de services sociaux de l'Estrie
Sherbrooke, Quebec, Canada
Centro de Investigacion Clinica del Sur
Temuco, Región de la Araucanía, Chile
Centro de Investigaciones Clinicas Vina del Mar
Viña del Mar, Región de Valparaíso, Chile
Centro de Investigaciones Clinicas Vina del Mar
Viña del Mar, Región de Valparaíso, Chile
Sociedad Prosalud Montes y Orlandi Ltda. Fantasy name (Orlandi Oncologia)
Santiago, Santiago Metropolitan, Chile
James Lind Centro de Investigación del Cáncer
Araucania, , Chile
The First affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, China
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, China
Urinary surgery, Ningbo First Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Beijing Hospital
Beijing, , China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Peking University First Hospital / Urology Department
Beijing, , China
Chongqing University Cancer Hospital
Chongqing, , China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, , China
Fudan University Cancer Hospital, Deptartment of Urology
Shanghai, , China
Shanghai Tenth People's Hospital
Shanghai, , China
The Fifth People's Hospital of Shanghai, Fudan University
Shanghai, , China
The Second Hospital of Tianjin Medical University
Tianjin, , China
Fakultní nemocnice Hradec Králové
Hradec Králové, , Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, , Czechia
Multiscan s.r.o.
Pardubice, , Czechia
Fakultní nemocnice Královské Vinohrady
Prague, , Czechia
HUS Helsinki University Hospital
Helsinki, , Finland
Docrates Cancer Center
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Oulun yliopistollinen sairaala
Oulu, , Finland
Pirkanmaan hyvinvointialue
Tampere, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Clinique Victor Hugo Le Mans
Le Mans, Pays de la Loire Region, France
Centre d'Oncologie du Pays-Basque
Bayonne, , France
Clinique Ramsay Belharra
Bayonne, , France
Hopital Saint Andre - CHU de Bordeaux
Bordeaux, , France
CHD Vendée
La Roche-sur-Yon, , France
Centre Leon Berard
Lyon, , France
Centre Léon Bérard
Lyon, , France
CHU Montpellier-Hopital Saint Eloi
Montpellier, , France
Hopital Saint-Louis
Paris, , France
Hopital Europeen Georges Pompidou
Paris, , France
Clinique Sainte Anne
Strasbourg, , France
Hopitaux Universitaires de Strasbourg - ICANS
Strasbourg, , France
Hopital Foch
Suresnes, , France
Hopital Foch
Suresnes, , France
Institut Gustave Roussy
Villejuif, , France
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitaetsklinik Heidelberg
Heidelberg, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Diagnostikzentrum
Kirchheim, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Studienpraxis Urologie
Nürtingen, , Germany
Semmelweis Egyetem Urologiai Klinika
Budapest, , Hungary
Országos Onkológiai Intézet
Budapest, , Hungary
Uzsoki Utcai Korhaz
Budapest, , Hungary
Uzsoki Utcai Kórház
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intezet
Pécs, , Hungary
Rambam Health Care Campus
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliero-Universitaria Policlinico Sant' Orsola Malpighi
Bologna, BO, Italy
ASST di Cremona
Cremona, CR, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Meldola, FC, Italy
Azienda Ospedaliera S. Maria
Terni, TN, Italy
Ospedale Santa Chiara
Trento, TN, Italy
AOU San Luigi Gonzaga
Orbassano, TO, Italy
Azienda Provinciale per i Servizi Sanitari, della Provincia Autonoma di Trento
Trento, Trentino-Alto Adige, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
Napoli, , Italy
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Hirosaki University School of Medicine & Hospital
Hirosaki, Aomori, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Kure, Hiroshima, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Kindai University Hospital
Sakai, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Chiba Cancer Center
Chiba, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
Tokushima University Hospital
Tokushima, , Japan
Yamagata Prefectural Central Hospital
Yamagata, , Japan
Yamagata University Hospital
Yamagata, , Japan
Tauranga Urology Research Limited
Tauranga, Bay of Plenty, New Zealand
Canterbury District Health Board
Christchurch, Canterbury, New Zealand
Waikato Hospital
Hamilton, Waikato Region, New Zealand
Auckland City Hospital
Auckland, , New Zealand
Sykehusapoteket Ostfold, Kalnes
Grålum, , Norway
Ostfold County Hospital, Kalnes
Grålum, , Norway
Akershus University Hospital
Lorenskog, , Norway
Oslo University Hospital -Ullevål & Radiumhospitalet
Oslo, , Norway
St. Olavs Hospital, Trondheim University Hospital
Trondheim, , Norway
Trondheim Hospital Pharmacy
Trondheim, , Norway
Clinica Monte Carmelo S.C.R.LTDA.
Arequipa, , Peru
Hospital Militar Central "Coronel Luis Arias Schreiber"
Lima, , Peru
Clinica Internacional Sede San Borja
Lima, , Peru
Clinica Oncosalud
Lima, , Peru
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza
Brzozów, , Poland
Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
Gdynia, , Poland
Przychodnia Lekarska "Komed" Roman Karaszewski
Konin, , Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina
Otwock, , Poland
City Clinic Sp. z o.o.
Warsaw, , Poland
NZOZ Szpital Mazovia; Oddzial urologiczny
Warsaw, , Poland
Centro Clínico Académico - Braga, Associação (2CABraga)
Braga, , Portugal
Instituto Português Oncologia de Coimbra Francisco Gentil - E.P.E
Coimbra, , Portugal
Fundação Champalimaud
Lisbon, , Portugal
Hospital da Luz Lisboa
Lisbon, , Portugal
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil
Porto, , Portugal
Cancercare Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern Cape, South Africa
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, South Africa
Wits Clinical Research
Parktown, Gauteng, South Africa
Cancercare Rondebosch Oncology
Cape Town, Western Cape, South Africa
Outeniqua Cancercare Oncology Unit
George, Western Cape, South Africa
Cape Town Oncology Trials
Kraaifontein, Western Cape, South Africa
Clinical Trial Pharmacy, National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Clinical Trial Center, Serverance Hospital, yonsei University Health System
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Cancer Center Clinical Trial, Asan Medical Center
Seoul, , South Korea
Clinical Trials Center Pharmacy
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Clinical Trial Pharmacy, The Catholic University of Korea
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Institut Catala d'Oncologia - ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Corporacio Sanitaria i Universitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario 12 De Octubre
Madrid, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands LÄN [se-14], Sweden
Karolinska Universitetssjukhuset
Solna, , Sweden
Cancercentrum
Umeå, , Sweden
University Hospitals Plymouth NHS Trust
Plymouth, Devon, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
Greater Glasgow Health Board J B Russell House, Gartnavel Royal Hospital
Glasgow, Scotland, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, United Kingdom
Royal Cornwall Hospitals NHS Trust
Cornwall, , United Kingdom
NHS Greater Glasgow and Clyde (Radiology/Scans Address)
Glasgow, , United Kingdom
NHS Greater Glasgow and Clyde, The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Clatterbridge Cancer Centre - Liverpool
Liverpool, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust, Charing Cross Hospital
London, , United Kingdom
Department of Oncology, Cancer and Haematology Centre, Churchill Hospital
Oxford, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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, Healy CG, Di Santo N, Laird AD, Zohren F, Agarwal N. First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: the phase 3 TALAPRO-2 trial. Nat Med. 2024 Jan;30(1):257-264. doi: 10.1038/s41591-023-02704-x. Epub 2023 Dec 4.
Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Heinrich D, Szczylik C, De Giorgi U, Young Joung J, 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. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial. Lancet. 2023 Jul 22;402(10398):291-303. doi: 10.1016/S0140-6736(23)01055-3. Epub 2023 Jun 4.
Agarwal N, Azad A, Shore ND, Carles J, Fay AP, Dunshee C, Karsh LI, Paccagnella ML, Santo ND, Elmeliegy M, Lin X, Czibere A, Fizazi K. Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 phase III study design. Future Oncol. 2022 Feb;18(4):425-436. doi: 10.2217/fon-2021-0811. Epub 2022 Jan 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
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Other Identifiers
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TALAPRO-2
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509087-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C3441021
Identifier Type: -
Identifier Source: org_study_id