Clinical trial NCT03395197: Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: mCRPC
Keywords: mCRPC (metastatic castration-resistant prostate cancer)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
First posted: 2018-01-10
Enrollment: 1054
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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.

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:

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).

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).

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
timeFrame: Post dose on Day 1 up to Day 66 in Part 1
measure: 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
timeFrame: Post dose on Day 1 up to Day 66 in Part 1
measure: Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
timeFrame: 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)
measure: Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
timeFrame: 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)
measure: Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: From the start of treatment to the time of first documented progression, or death (maximum up to 42 months)
measure: BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2
timeFrame: From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Urological Institute dba Alaska Clinical Research Center
state: Alaska
city: Chandler
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
state: Arizona
city: Gilbert
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
state: Arizona
city: Mesa
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
state: Arizona
city: Mesa
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
state: Arizona
city: Scottsdale
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
state: Arizona
city: Tucson
country: United States
facility: Arizona Urology Specialists
state: Arizona
city: Tucson
country: United States
facility: Arizona Urology Specialists
state: Arizona
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Chula Vista
country: United States
facility: South County Hematology/Oncology
state: California
city: Chula Vista
country: United States
facility: Sharp Rees-Stealy
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care, Inc.
state: California
city: La Mesa
country: United States
facility: Cancer Center Oncology Medical Group
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center - Records Management Only
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center - Hematology/Oncology Clinic
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: UCLA Clark Urology Center
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Incorporation
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: San Diego
country: United States
facility: Medical Oncology Associates-SD
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital Investigational Pharmacy
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy
state: California
city: Stanford
country: United States
facility: Stanford Health Care
state: California
city: Aurora
country: United States
facility: University of Colorado Denver CTO/CTRC
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Cancer Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital- Anschutz Inpatient Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital- Anschutz Outpatient Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Altamonte Springs
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Brandon
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Clearwater
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Daytona Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Gainesville
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Health Hollis Cancer Center
state: Florida
city: Largo
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Lecanto
country: United States
facility: Florida Cancer Specialists
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Ocala
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orange City
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: AdventHealth Medical Group Hermatology and Oncology
state: Florida
city: Orlando
country: United States
facility: Investigational Drug Services, Advent Health Orlando
state: Florida
city: Orlando
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Spring Hill
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Stuart
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tavares
country: United States
facility: Florida Cancer Specialists
state: Florida
city: The Villages
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Vero Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Wellington
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Winter Park
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Fayetteville
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Newnan
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Newnan
country: United States
facility: Southeastern Regional Medical Center
state: Georgia
city: Chicago
country: United States
facility: Cook County Health (CCH)
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
state: Illinois
city: Hinsdale
country: United States
facility: AMITA Health Adventist Medical Center Hinsdale
state: Illinois
city: Hinsdale
country: United States
facility: AMITA Health Cancer Institute
state: Illinois
city: Zion
country: United States
facility: Midwestern Regional Medical Center
state: Illinois
city: Jeffersonville
country: United States
facility: Clark Memorial Hospital Radiology
state: Indiana
city: Jeffersonville
country: United States
facility: First Urology, PSC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
city: Fairway
country: United States
facility: The University of Kansas Clinical Research Center
state: Kansas
city: Westwood
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Saint Louis
country: United States
facility: VA Saint Louis Healthcare System
state: Missouri
city: Omaha
country: United States
facility: XCancer Omaha / Urology Cancer Center, PC d/b/a XCancer
state: Nebraska
city: Belleville
country: United States
facility: Clara Maass Medical Center
state: New Jersey
city: Belleville
country: United States
facility: New Jersey Cancer Care and Blood Disorders
state: New Jersey
city: Nutley
country: United States
facility: University Radiology
state: New Jersey
city: Voorhees
country: United States
facility: New Jersey Urology, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Urology Group of New Mexico
state: New Mexico
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center - Montefiore Medical Park
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley PC
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of New York, PLLC
state: New York
city: Cincinnati
country: United States
facility: TriState urologic Services PSC Inc., dba The Urology Group
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Clackamas
country: United States
facility: Kaiser Sunnyside Medical Center
state: Oregon
city: Hillsboro
country: United States
facility: Kaiser Westside Medical Center
state: Oregon
city: Newberg
country: United States
facility: Providence Cancer Institute Newberg Clinic
state: Oregon
city: Newberg
country: United States
facility: Providence Newberg Medical Center
state: Oregon
city: Oregon City
country: United States
facility: Providence Cancer Institute Willamette Falls
state: Oregon
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Oncology and Hematology Care Clinic - Westside
state: Oregon
city: Portland
country: United States
facility: Providence St Vincent Medical Center
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Altoona
country: United States
facility: UPMC Hillman Cancer Center - Altoona
state: Pennsylvania
city: Bethel Park
country: United States
facility: UPMC Hillman Cancer Center - Upper St. Clair
state: Pennsylvania
city: Greensburg
country: United States
facility: UPMC Hillman Cancer Center - Arnold Palmer - Mt View
state: Pennsylvania
city: Lancaster
country: United States
facility: Keystone Urology Specialists
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC Hillman Cancer Center - Monroeville
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center - Passavant (HOA)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center - Passavant (OHA)
state: Pennsylvania
city: Seneca
country: United States
facility: UPMC Hillman Cancer Center - Northwest
state: Pennsylvania
city: Uniontown
country: United States
facility: UPMC Hillman Cancer Center - Uniontown
state: Pennsylvania
city: Washington
country: United States
facility: UPMC Hillman Cancer Center - Washington
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Chattanooga
country: United States
facility: Greco-Hainesworth Tennessee Oncology Centers for Research
state: Tennessee
city: Chattanooga
country: United States
facility: Tennessee oncology, PLLC
state: Tennessee
city: Cleveland
country: United States
facility: Tennesse Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates P.C.
state: Tennessee
city: Nashville
country: United States
facility: The Vanderbilt Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbuilt University Medical Center, Department of Urology
state: Tennessee
city: Austin
country: United States
facility: Urology Austin PLLC
state: Texas
city: El Paso
country: United States
facility: Rio Grande Urology, P.A.
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Round Rock
country: United States
facility: Urology Austin, PLLC
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
city: Farmington
country: United States
facility: Farmington Health Center -University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah, Huntsman Cancer Institute
state: Utah
city: Salt Lake City
country: United States
facility: Redwood Health Center-University of Utah
state: Utah
city: South Jordan
country: United States
facility: South Jordan Health Center -University of Utah
state: Utah
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute Infusion Pharmacy
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Clinical Science Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA - Clinica Pergamino SA
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario
state: Santa FE
city: Caba
country: Argentina
facility: Hospital Británico de Buenos Aires
city: Caba
country: Argentina
facility: Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" Cemic
city: Cordoba
country: Argentina
facility: Clinica Universitaria Reina Fabiola
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Centre Wesley
state: Queensland
city: Auchenflower
country: Australia
facility: River City Pharmacy
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Chermside
country: Australia
facility: ICON Cancer Centre Chermside
state: Queensland
city: South Brisbane
country: Australia
facility: ICON Cancer Centre South Brisbane
state: Queensland
city: South Brisbane
country: Australia
facility: Integrated Clinical Oncology Network Pty Ltd (ICON)
state: Queensland
city: Southport
country: Australia
facility: ICON Cancer Centre Southport
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: North Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Gent
country: Belgium
facility: A.Z. Sint-Lucas
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre Ottignies
city: Yvoir
country: Belgium
facility: CHU UCL Namur site Godinne
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Pedro Ernesto-Centro de Pesquisas (CEPUSA)
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Hospital CopaDor
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Hospital Gloria D'Or
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Oncologia D'Or
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Oncologia D'Or
state: RJ
city: Ijui
country: Brazil
facility: Associacao Hospital de Caridade de Ijui
state: RS
city: Lajeado
country: Brazil
facility: Sociedade Beneficencia e Caridade de Lajeado - Hospital Bruno Born
state: RS
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa Clinica em Oncologia - Hospital Sao Lucas da Pontificia Universidade Catolica
state: RS
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado - Hospital Mae de Deus
state: RS
city: Porto Alegre
country: Brazil
facility: MedPlex Eixo Norte
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao
state: RS
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
state: SP
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa de Hematologia e Oncologia (CEPHO)
state: SP
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia (CEPHO)
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo-ICESP-Nucleo de Pesquisa
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
state: SP
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre - Alberta Health Services
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Center
state: Ontario
city: Chicoutimi
country: Canada
facility: Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre integre universitaire de sante et de services sociaux de l'Estrie
state: Quebec
city: Santiago
country: Chile
facility: Sociedad Prosalud Montes y Orlandi Ltda. Fantasy name (Orlandi Oncologia)
state: Metropolitana
city: Temuco
country: Chile
facility: Centro de Investigacion Clinica del Sur
state: Region DE LA Araucania
city: Vina del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina del Mar
state: Valparaiso
city: Vina del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina del Mar
state: Valparaiso
city: Araucania
country: Chile
facility: James Lind Centro de Investigación del Cáncer
city: Hefei
country: China
facility: The First affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: First Affiliated Hospital of Xiamen University
state: Fujian
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Second Affiliated Hospital of Suzhou University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The first affiliated hospital of Ningbo university
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University First Hospital / Urology Department
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Fudan University Cancer Hospital, Deptartment of Urology
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Shanghai
country: China
facility: The Fifth People's Hospital of Shanghai, Fudan University
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Hradec Kralove
country: Czechia
facility: Fakultní nemocnice Hradec Králové
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Pardubice
country: Czechia
facility: Multiscan s.r.o.
city: Praha 10
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady
city: Helsinki
country: Finland
facility: HUS Helsinki University Hospital
city: Helsinki
country: Finland
facility: Docrates Cancer Center
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Le Mans
country: France
facility: Clinique Victor Hugo Le Mans
state: Pays-de-la-loire
city: Bayonne
country: France
facility: Centre d'Oncologie du Pays-Basque
city: Bayonne
country: France
facility: Clinique Ramsay Belharra
city: Bordeaux
country: France
facility: Hopital Saint Andre - CHU de Bordeaux
city: LA ROCHE SUR YON cedex 9
country: France
facility: CHD Vendée
city: Lyon CEDEX 08
country: France
facility: Centre Léon Bérard
city: Montpellier cedex 5
country: France
facility: CHU Montpellier-Hopital Saint Eloi
city: Paris Cedex 15
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Saint-Louis
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg - ICANS
city: Suresnes Cedex
country: France
facility: Hopital Foch
city: Suresnes
country: France
facility: Hopital Foch
city: VILLEJUIF cedex
country: France
facility: Institut Gustave Roussy
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitaetsklinik Heidelberg
city: Kirchheim
country: Germany
facility: Diagnostikzentrum
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Urologiai Klinika
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Budapest
country: Hungary
facility: Uzsoki Utcai Kórház
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intezet
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Sant' Orsola Malpighi
state: BO
city: Cremona
country: Italy
facility: ASST di Cremona
state: CR
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
state: FC
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria
state: TN
city: Trento
country: Italy
facility: Ospedale Santa Chiara
state: TN
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga
state: TO
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University School of Medicine & Hospital
state: Aomori
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center
state: Hiroshima
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
state: Kanagawa
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine, University Hospital
state: Shizuoka
city: Meguro-ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Goyang-si
country: Korea, Republic of
facility: Clinical Trial Pharmacy, National Cancer Center
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Cancer Center Clinical Trial, Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Clinical Trials Center Pharmacy
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Pharmacy, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Urology Research Limited
state: BAY OF Plenty
city: Christchurch
country: New Zealand
facility: Canterbury District Health Board
state: Canterbury
city: Hamilton
country: New Zealand
facility: Waikato Hospital
state: Waikato
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Gralum
country: Norway
facility: Sykehusapoteket Ostfold, Kalnes
city: Gralum
country: Norway
facility: Ostfold County Hospital, Kalnes
city: Lorenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital -Ullevål & Radiumhospitalet
city: Trondheim
country: Norway
facility: St. Olavs Hospital, Trondheim University Hospital
city: Arequipa
country: Peru
facility: Clinica Monte Carmelo S.C.R.LTDA.
city: Lima
country: Peru
facility: Hospital Militar Central "Coronel Luis Arias Schreiber"
city: Lima
country: Peru
facility: Clinica Internacional Sede San Borja
city: Lima
country: Peru
facility: Clinica Oncosalud
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
city: Konin
country: Poland
facility: Przychodnia Lekarska "Komed" Roman Karaszewski
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina
city: Warszawa
country: Poland
facility: City Clinic Sp. z o.o.
city: Warszawa
country: Poland
facility: NZOZ Szpital Mazovia; Oddzial urologiczny
city: Braga
country: Portugal
facility: Centro Clínico Académico - Braga, Associação (2CABraga)
city: Coimbra
country: Portugal
facility: Instituto Português Oncologia de Coimbra Francisco Gentil - E.P.E
city: Lisboa
country: Portugal
facility: Fundação Champalimaud
city: Lisboa
country: Portugal
facility: Hospital da Luz Lisboa
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo Antonio
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil
city: Port Elizabeth
country: South Africa
facility: Cancercare Langenhoven Drive Oncology Centre
state: Eastern CAPE
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
state: Gauteng
city: Parktown
country: South Africa
facility: Wits Clinical Research
state: Gauteng
city: Cape Town
country: South Africa
facility: Cancercare Rondebosch Oncology
state: Western CAPE
city: George
country: South Africa
facility: Outeniqua Cancercare Oncology Unit
state: Western CAPE
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials
state: Western CAPE
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
state: A Coruna
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia - ICO L'Hospitalet
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria i Universitaria Parc Tauli
state: Barcelona
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Gothenburg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
state: Västra Götalands LÄN [se-14]
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Umeå
country: Sweden
facility: Cancercentrum
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
state: Devon
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
city: Glasgow
country: United Kingdom
facility: Greater Glasgow Health Board J B Russell House, Gartnavel Royal Hospital
state: Scotland
city: Bebington
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
state: Wirral
city: Cornwall
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: The Clatterbridge Cancer Centre - Liverpool
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, Charing Cross Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.