Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
- Conditions
- mCRPC
- Interventions
- Registration Number
- NCT03395197
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 1054
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
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination arm Talazoparib with enzalutamide Talazoparib plus enzalutamide Monotherapy arm Placebo with enzalutamide Ezalutamide plus placebo
- Primary Outcome Measures
Name Time Method Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1 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) 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.
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 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) 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1 Post dose on Day 1 up to Day 66 in 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.
Number of Participants With All-Causality TEAEs During the Overall Period of Part 1 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) 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.
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 From the start of treatment to the time of first documented progression, or death (maximum up to 42 months) 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.
BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2 From the start of treatment to the time of first documented progression, or death (maximum up to 38 months) 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.
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 Post dose on Day 1 up to Day 66 in 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.
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1 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) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (336)
Cook County Health (CCH)
🇺🇸Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
🇺🇸Chicago, Illinois, 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
Houston Metro Urology
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Medical Oncology Associates-SD
🇺🇸San Diego, California, United States
Sharp Memorial Hospital Investigational Pharmacy
🇺🇸San Diego, California, 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
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
Providence St Vincent Medical Center
🇺🇸Portland, Oregon, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, 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
🇺🇸Portland, Oregon, United States
Kaiser Permanente Northwest
🇺🇸Portland, Oregon, United States
GU Research Network/Urology Cancer Center
🇺🇸Omaha, Nebraska, United States
XCancer Omaha / Urology Cancer Center, PC d/b/a XCancer
🇺🇸Omaha, Nebraska, 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 first affiliated hospital of Ningbo university
🇨🇳Ningbo, Zhejiang, China
St. Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Icon Cancer Centre Wesley
🇦🇺Auchenflower, Queensland, Australia
Greater Glasgow Health Board J B Russell House, Gartnavel Royal Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, Oxfordshire, United Kingdom
Arizona Urology Specialists
🇺🇸Tucson, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
🇺🇸Scottsdale, Arizona, United States
Beverly Hills Cancer Center
🇺🇸Beverly Hills, California, United States
Alaska Urological Institute dba Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
Sharp Rees-Stealy
🇺🇸San Diego, California, United States
South County Hematology/Oncology
🇺🇸Chula Vista, California, United States
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States
UCLA Clark Urology Center
🇺🇸Los Angeles, California, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
Cancer Center Oncology Medical Group
🇺🇸La Mesa, California, United States
Marin Cancer Care, Inc.
🇺🇸Greenbrae, 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
Stanford Cancer Institute
🇺🇸Palo Alto, California, United States
Stanford Health Care
🇺🇸Stanford, California, United States
Lakeland Regional Health Hollis Cancer Center
🇺🇸Lakeland, Florida, United States
Piedmont Cancer Institute
🇺🇸Newnan, Georgia, United States
AdventHealth Medical Group Hematology & Oncology at Celebration
🇺🇸Celebration, Florida, United States
Southeastern Regional Medical Center
🇺🇸Newnan, Georgia, 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
University of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States
The University of Kansas Clinical Research Center
🇺🇸Fairway, Kansas, United States
First Urology, PSC
🇺🇸Jeffersonville, Indiana, United States
The University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
Clara Maass Medical Center
🇺🇸Belleville, New Jersey, United States
VA Saint Louis Healthcare System
🇺🇸Saint Louis, Missouri, 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, New Jersey, United States
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
TriState urologic Services PSC Inc., dba The Urology Group
🇺🇸Cincinnati, Ohio, 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
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research Solutions
🇺🇸Middleburg Heights, Ohio, United States
Kaiser Westside Medical Center
🇺🇸Hillsboro, Oregon, United States
Kaiser Sunnyside Medical Center
🇺🇸Clackamas, Oregon, United States
Providence Cancer Institute Willamette Falls
🇺🇸Oregon City, Oregon, United States
UPMC Hillman Cancer Center - Altoona
🇺🇸Altoona, Pennsylvania, United States
UPMC Hillman Cancer Center - Upper St. Clair
🇺🇸Bethel Park, Pennsylvania, United States
Keystone Urology Specialists
🇺🇸Lancaster, Pennsylvania, United States
UPMC Hillman Cancer Center - Arnold Palmer - Mt View
🇺🇸Greensburg, Pennsylvania, United States
UPMC Hillman Cancer Center - Monroeville
🇺🇸Monroeville, Pennsylvania, United States
UPMC Hillman Cancer Center - Northwest
🇺🇸Seneca, Pennsylvania, United States
UPMC Hillman Cancer Center - Washington
🇺🇸Washington, Pennsylvania, United States
UPMC Hillman Cancer Center - Uniontown
🇺🇸Uniontown, Pennsylvania, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Tennesse Oncology, PLLC
🇺🇸Cleveland, Tennessee, United States
Rio Grande Urology, P.A.
🇺🇸El Paso, 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
Swedish Cancer Institute
🇺🇸Seattle, Washington, 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
Centro de Investigacion Pergamino SA - Clinica Pergamino SA
🇦🇷Pergamino, Buenos Aires, Argentina
Instituto de Oncologia de Rosario
🇦🇷Rosario, Santa FE, Argentina
Hospital Británico de Buenos Aires
🇦🇷Caba, Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" Cemic
🇦🇷Caba, Argentina
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Clinica Universitaria Reina Fabiola
🇦🇷Cordoba, Argentina
Hospital Privado Centro Medico de Cordoba
🇦🇷Cordoba, Argentina
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Port Macquarie Base Hospital
🇦🇺Port Macquarie, New South Wales, Australia
ICON Cancer Centre Chermside
🇦🇺Chermside, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
ICON Cancer Centre South Brisbane
🇦🇺South Brisbane, Queensland, Australia
River City Pharmacy
🇦🇺Auchenflower, Queensland, Australia
Integrated Clinical Oncology Network Pty Ltd (ICON)
🇦🇺South Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
🇦🇺North Melbourne, Victoria, Australia
ICON Cancer Centre Southport
🇦🇺Southport, Queensland, Australia
AZ Klina
🇧🇪Brasschaat, Belgium
A.Z. Sint-Lucas
🇧🇪Gent, Belgium
UZ Gent
🇧🇪Gent, Belgium
AZ Groeninge
🇧🇪Kortrijk, Belgium
CHU UCL Namur site Godinne
🇧🇪Yvoir, Belgium
Clinique Saint-Pierre Ottignies
🇧🇪Ottignies, Belgium
Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital Universitario Pedro Ernesto-Centro de Pesquisas (CEPUSA)
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital CopaDor
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital Gloria D'Or
🇧🇷Rio de Janeiro, RJ, Brazil
Oncologia D'Or
🇧🇷Rio de Janeiro, RJ, Brazil
Instituto D'Or de Pesquisa e Ensino
🇧🇷Rio de Janeiro, RJ, Brazil
Associacao Hospital de Caridade de Ijui
🇧🇷Ijui, RS, Brazil
Sociedade Beneficencia e Caridade de Lajeado - Hospital Bruno Born
🇧🇷Lajeado, RS, Brazil
Centro de Pesquisa Clinica em Oncologia - Hospital Sao Lucas da Pontificia Universidade Catolica
🇧🇷Porto Alegre, RS, Brazil
Centro Gaucho Integrado - Hospital Mae de Deus
🇧🇷Porto Alegre, RS, Brazil
MedPlex Eixo Norte
🇧🇷Porto Alegre, RS, Brazil
Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao
🇧🇷Porto Alegre, RS, Brazil
Tom Baker Cancer Centre - Alberta Health Services
🇨🇦Calgary, Alberta, Canada
Fundacao Pio XII - Hospital de Cancer de Barretos
🇧🇷Barretos, SP, Brazil
Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa de Hematologia e Oncologia (CEPHO)
🇧🇷Santo Andre, SP, Brazil
Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia (CEPHO)
🇧🇷Santo Andre, SP, Brazil
Hospital Alemão Oswaldo Cruz
🇧🇷Sao Paulo, SP, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
🇧🇷Sao Paulo, SP, Brazil
Instituto do Cancer do Estado de Sao Paulo-ICESP-Nucleo de Pesquisa
🇧🇷Sao Paulo, SP, Brazil
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
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
Sociedad Prosalud Montes y Orlandi Ltda. Fantasy name (Orlandi Oncologia)
🇨🇱Santiago, Metropolitana, Chile
Centro de Investigacion Clinica del Sur
🇨🇱Temuco, Region DE LA Araucania, Chile
Sociedad de Investigaciones Medicas Ltda (SIM)
🇨🇱Temuco, Region DE LA Araucania, Chile
Peking University First Hospital / Urology Department
🇨🇳Beijing, China
Centro de Investigaciones Clinicas Vina del Mar
🇨🇱Vina del Mar, Valparaiso, Chile
James Lind Centro de Investigación del Cáncer
🇨🇱Araucania, Chile
The First affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Hospital
🇨🇳Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital Of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, 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 Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
Second Affiliated Hospital of Suzhou University
🇨🇳Suzhou, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Jilin Province Tumor Hospital
🇨🇳Changchun, Jilin, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, 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
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
The First Affiliated Hosptial of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, 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 Kralove, Czechia
Fakultni nemocnice Ostrava
🇨🇿Ostrava-Poruba, Czechia
Multiscan s.r.o.
🇨🇿Pardubice, Czechia
Fakultní nemocnice Královské Vinohrady
🇨🇿Praha 10, Czechia
HUS Helsinki University Hospital
🇫🇮Helsinki, Finland
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
Docrates Cancer Center
🇫🇮Helsinki, Finland
OYS apteekki
🇫🇮Kempele, Finland
Kuopio University Hospital
🇫🇮Kuopio, Finland
Oulun yliopistollinen sairaala
🇫🇮Oulu, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Turku University Hospital
🇫🇮Turku, Finland
Centre d'Oncologie du Pays-Basque
🇫🇷Bayonne, France
Centre de cancerologie de la Sarthe
🇫🇷Le Mans, France
Clinique Ramsay Belharra
🇫🇷Bayonne, France
Hopital Saint Andre - CHU de Bordeaux
🇫🇷Bordeaux, France
CHD Vendée
🇫🇷LA ROCHE SUR YON cedex 9, France
Clinique Victor Hugo-Centre Jean Bernard
🇫🇷Le Mans, France
Clinique Victor Hugo
🇫🇷Le Mans, France
Centre Leon Berard
🇫🇷Lyon Cedex 08, France
Hopital Saint-Louis
🇫🇷Paris, France
Centre Léon Bérard
🇫🇷Lyon CEDEX 08, France
CHU Montpellier-Hopital Saint Eloi
🇫🇷Montpellier cedex 5, France
Hopital Europeen Georges Pompidou
🇫🇷Paris Cedex 15, France
Clinique Sainte Anne
🇫🇷Strasbourg, France
Hopitaux Universitaires de Strasbourg - ICANS
🇫🇷Strasbourg, France
Hopital Foch
🇫🇷Suresnes, France
Institut Gustave Roussy
🇫🇷VILLEJUIF cedex, France
Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Semmelweis Egyetem Urologiai Klinika
🇭🇺Budapest, Hungary
Universitaetsklinik Heidelberg
🇩🇪Heidelberg, Germany
Diagnostikzentrum
🇩🇪Kirchheim, Germany
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Studienpraxis Urologie
🇩🇪Nuertingen, Germany
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
🇭🇺Pecs, Hungary
Rambam Health Care Campus
🇮🇱Haifa, Israel
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
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Azienda Ospedaliero-Universitaria Policlinico Sant' Orsola Malpighi
🇮🇹Bologna, BO, Italy
Ospedale Santa Chiara
🇮🇹Trento, TN, Italy
AOU San Luigi Gonzaga
🇮🇹Orbassano, TO, Italy
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Hirosaki University School of Medicine & Hospital
🇯🇵Hirosaki, Aomori, Japan
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
🇮🇹Napoli, Italy
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, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Osaka International Cancer Institute
🇯🇵Osaka-shi, Osaka, Japan
Yokosuka Kyosai Hospital
🇯🇵Yokosuka, Kanagawa, Japan
Kindai University Hospital
🇯🇵Osakasayama, Osaka, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Hamamatsu University School of Medicine, University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Meguro-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
Clinical Trial Pharmacy, National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Tauranga Urology Research Limited
🇳🇿Tauranga, BAY OF Plenty, New Zealand
Waikato Hospital
🇳🇿Hamilton, Waikato, New Zealand
Canterbury District Health Board
🇳🇿Christchurch, Canterbury, New Zealand
Auckland City Hospital
🇳🇿Auckland, New Zealand
Sykehusapoteket Ostfold, Kalnes
🇳🇴Gralum, Norway
Ostfold County Hospital, Kalnes
🇳🇴Gralum, Norway
Akershus University Hospital
🇳🇴Lorenskog, Norway
Oslo University Hospital -Ullevål & Radiumhospitalet
🇳🇴Oslo, Norway
St. Olavs Hospital, Trondheim University Hospital
🇳🇴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
🇵🇱Brzozow, 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.
🇵🇱Warszawa, Poland
NZOZ Szpital Mazovia; Oddzial urologiczny
🇵🇱Warszawa, Poland
Centro Clínico Académico - Braga, Associação (2CABraga)
🇵🇹Braga, Portugal
Instituto Português Oncologia de Coimbra Francisco Gentil - E.P.E
🇵🇹Coimbra, Portugal
Fundação Champalimaud
🇵🇹Lisboa, Portugal
Hospital da Luz Lisboa
🇵🇹Lisboa, Portugal
Centro Hospitalar do Porto - Hospital de Santo Antonio
🇵🇹Porto, Portugal
Cancercare Langenhoven Drive Oncology Centre
🇿🇦Port Elizabeth, Eastern CAPE, South Africa
Instituto Português de Oncologia do Porto Francisco Gentil
🇵🇹Porto, Portugal
Wits Clinical Research
🇿🇦Johannesburg, South Africa
The Medical Oncology Centre of Rosebank
🇿🇦Johannesburg, Gauteng, South Africa
Outeniqua Cancercare Oncology Unit
🇿🇦George, Western CAPE, South Africa
Cape Town Oncology Trials
🇿🇦Kraaifontein, Cape Town, Western CAPE, South Africa
Hospital Clinico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruna, Spain
Cancercare Rondebosch Oncology
🇿🇦Cape Town, Western CAPE, South Africa
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Institut Catala d'Oncologia - ICO L'Hospitalet
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Klinisk Provningsenhet (KPE) Onkologi
🇸🇪Goteborg, Sweden
Patientomrade Backencancer, Tema Cancer
🇸🇪Stockholm, Sweden
Hospital Universitario 12 De Octubre
🇪🇸Madrid, Spain
University Hospitals Plymouth NHS Trust
🇬🇧Plymouth, Devon, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
🇬🇧Bebington, Wirral, United Kingdom
Cancercentrum
🇸🇪Umeå, Sweden
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
NHS Greater Glasgow and Clyde
🇬🇧Glasgow, United Kingdom
Imperial College Healthcare NHS Trust, Charing Cross Hospital
🇬🇧London, United Kingdom
The Clatterbridge Cancer Centre - Liverpool
🇬🇧Liverpool, United Kingdom
Oxford University Hospitals NHS Trust
🇬🇧Oxford, United Kingdom
AdventHealth Hematology and Oncology
🇺🇸Orlando, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Investigational Drug Services, Advent Health Orlando
🇺🇸Orlando, Florida, United States
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Sarah Cannon Research Institute
🇺🇸Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC
🇺🇸Chattanooga, Tennessee, United States
MD Anderson Cancer Center
🇪🇸Madrid, Spain
Providence Cancer Institute Clackamas Clinic
🇺🇸Clackamas, Oregon, United States
Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital (CMJAH), Clinical Trial Site
🇿🇦Johannesburg, Gauteng, South Africa
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Providence Cancer Institute Newberg Clinic
🇺🇸Newberg, Oregon, United States
AdventHealth Medical Group Hematology & Oncology at Kissimmee
🇺🇸Kissimmee, Florida, United States
Desert Hematology Oncology Medical Group, Incorporation
🇺🇸Rancho Mirage, California, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
Florida Cancer Specialists
🇺🇸Winter Park, Florida, United States
Providence Newberg Medical Center
🇺🇸Newberg, Oregon, United States
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Cancer Center Clinical Trial, Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Clinical Trials Center Pharmacy
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Clinical Trial Pharmacy, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Montefiore Medical Center - Montefiore Medical Park
🇺🇸Bronx, New York, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Urology Austin PLLC
🇺🇸Austin, Texas, United States
Urology Group of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of Wisconsin Clinical Science Center
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Hospital & Clinics
🇺🇸Madison, Wisconsin, United States
Corporacio Sanitaria i Universitaria Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Royal Cornwall Hospitals NHS Trust
🇬🇧Cornwall, United Kingdom