MedPath

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

Phase 3
Active, not recruiting
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
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

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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).

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Combination armTalazoparib with enzalutamideTalazoparib plus enzalutamide
Monotherapy armPlacebo with enzalutamideEzalutamide plus placebo
Primary Outcome Measures
NameTimeMethod
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1Post 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 1Post 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 1Post 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 1Post 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 1From 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 2From 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 1Post 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 1Post 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
NameTimeMethod

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

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