A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

NCT ID: NCT05288166

Last Updated: 2025-06-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

925 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-14

Study Completion Date

2027-10-31

Brief Summary

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The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.

Detailed Description

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Conditions

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Prostatic Neoplasms Neoplasm Metastasis Urogenital Neoplasms Physiological Effects of Drugs Antineoplastic Agents Antineoplastic Agents, Hormonal Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Abiraterone Acetate Steroid Synthesis Inhibitors Cytochrome P-450 Enzyme Inhibitors Prednisone Prednisolone Cyclin-Dependent Kinase 4 Cyclin-Dependent Kinase 6

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Abemaciclib

Participants received 200 milligram (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally.

Abiraterone

Intervention Type DRUG

Administered orally.

Prednisone or Prednisolone

Intervention Type DRUG

Administered orally.

Placebo

Participants received placebo BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Group Type ACTIVE_COMPARATOR

Abiraterone

Intervention Type DRUG

Administered orally.

Prednisone or Prednisolone

Intervention Type DRUG

Administered orally.

Placebo for Abemaciclib

Intervention Type DRUG

Administered orally.

Interventions

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Abemaciclib

Administered orally.

Intervention Type DRUG

Abiraterone

Administered orally.

Intervention Type DRUG

Prednisone or Prednisolone

Administered orally.

Intervention Type DRUG

Placebo for Abemaciclib

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LY2835219

Eligibility Criteria

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Inclusion Criteria

* Adenocarcinoma of the prostate (as the predominant histology)
* High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as:

* Greater than or equal to (≥)4 bone metastases by bone scan and/or
* ≥1 visceral metastases by computed tomography or magnetic resonance imaging
* Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen.
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

* Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 \& 6) inhibitor
* Development of metastatic prostate cancer in the context of castrate levels of testosterone
* Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for ADT and first-generation anti-androgen
* Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure
* History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted
* Uncontrolled hypertension
* Clinically active or chronic liver disease, moderate/severe hepatic impairment
* Known untreated central nervous system (CNS) metastasis. Participants with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Arizona Oncology Associates, P.C. - HOPE

Prescott, Arizona, United States

Site Status

Arizona Oncology Associates, P.C. - HOPE

Prescott Valley, Arizona, United States

Site Status

The University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States

Site Status

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, United States

Site Status

St. Bernards Medical Center

Jonesboro, Arkansas, United States

Site Status

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status

Orange Coast Memorial Medical Center

Fountain Valley, California, United States

Site Status

Providence Medical Foundation

Fullerton, California, United States

Site Status

Moores Cancer Center

La Jolla, California, United States

Site Status

MemorialCare Health System - Long Beach Medical Center

Long Beach, California, United States

Site Status

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Site Status

UCLA Hematology/Oncology - Santa Monica

Los Angeles, California, United States

Site Status

Torrance Memorial Physician Network / Cancer Care

Torrance, California, United States

Site Status

PIH Health Hematology Medical Oncology

Whittier, California, United States

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

UCHealth Memorial Hospital

Colorado Springs, Colorado, United States

Site Status

UCHealth Harmony

Fort Collins, Colorado, United States

Site Status

Colorado West Healthcare System - Grand Valley Oncology

Grand Junction, Colorado, United States

Site Status

USO-Rocky Mountain Cancer Center

Littleton, Colorado, United States

Site Status

Florida Cancer Specialists - South

Fort Myers, Florida, United States

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Memorial Regional Hospital

Hollywood, Florida, United States

Site Status

Millennium Oncology Research Clinic

Hollywood, Florida, United States

Site Status

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, United States

Site Status

Florida Cancer Specialist- East

West Palm Beach, Florida, United States

Site Status

Dwight D Eisenhower Army Medical Center

Fort Gordon, Georgia, United States

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Northeast Georgia Medical Center

Gainesville, Georgia, United States

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Central Georgia Cancer Care

Macon, Georgia, United States

Site Status

Summit Cancer Care DBA Candler Medical Oncology Practice

Savannah, Georgia, United States

Site Status

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Site Status

The University of Louisville, James Graham Brown Cancer Center

Louisville, Kentucky, United States

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Sarah Cannon Research Institute

Baton Rouge, Louisiana, United States

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Chesapeake Urology

Towson, Maryland, United States

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Massachusetts General Hospital

Boston, Massachusetts, United States

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Reliant Medical Group

Worcester, Massachusetts, United States

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University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

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Minnesota Oncology/Hematology PA

Minneapolis, Minnesota, United States

Site Status

Care Access - Clifton

Clifton, New Jersey, United States

Site Status

Maimonides Cancer Center

Brooklyn, New York, United States

Site Status

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, United States

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Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Site Status

Associated Medical Professionals - Urology

Syracuse, New York, United States

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Clinical Research Alliance

Westbury, New York, United States

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TriState Urologic Services PSC Inc.

Cincinnati, Ohio, United States

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Northwest Cancer Specialist

Tigard, Oregon, United States

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MidLantic urology

Bala-Cynwyd, Pennsylvania, United States

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AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

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Tennessee Oncology Chattanooga-SCRI

Chattanooga, Tennessee, United States

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University of Tennessee Medical Center

Knoxville, Tennessee, United States

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Sarah Cannon Research Institute

Nashville, Tennessee, United States

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Texas Oncology - Balcones

Austin, Texas, United States

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Parkland Health and Hospital System

Dallas, Texas, United States

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UT Southwestern Medical Center

Dallas, Texas, United States

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Texas Oncology - Carrollton

Flower Mound, Texas, United States

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The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

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Houston Methodist Hospital

Houston, Texas, United States

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Urology San Antonio Research

San Antonio, Texas, United States

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USO - Texas Oncology Gulf Coast

Sugar Land, Texas, United States

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Baylor Scott & White Medical Center - Temple

Temple, Texas, United States

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US Oncology Research Network

The Woodlands, Texas, United States

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Texas Oncology - Longview Cancer Center

Tyler, Texas, United States

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Huntsman Cancer Institute

Salt Lake City, Utah, United States

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The University of Vermont Medical Center Inc.

Burlington, Vermont, United States

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Oncology and Hematology Associates of Southwest Virginia Inc

Roanoke, Virginia, United States

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Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

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Investigaciones Clinicas Moleculares (ICM)

Buenos Aires, Buenos Aires F.D., Argentina

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Asociación de Beneficencia Hospital Sirio Libanés

Buenos Aires, Buenos Air, Argentina

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Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

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Fundación Cenit Para La Investigación En Neurociencias

CABA, Ciudad Autónoma de Buenos Aire, Argentina

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Centro Medico Privado CEMAIC

Capital, Córdoba Province, Argentina

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Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

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Clinica Viedma

Viedma, Río Negro Province, Argentina

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Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, Argentina

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Centro Oncologico Korben

Buenos Aires, , Argentina

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Fundación Respirar

Buenos Aires, , Argentina

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Centro Urológico Profesor Bengió

Córdoba, , Argentina

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Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

San Juan, , Argentina

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Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

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Coffs Harbour Health Campus

Coffs Harbour, New South Wales, Australia

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St Vincent's Hospital

Darlinghurst, New South Wales, Australia

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Liverpool Hospital

Liverpool, New South Wales, Australia

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Macquarie University

Macquarie University, New South Wales, Australia

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Icon Cancer Centre South Brisbane

South Brisbane, Queensland, Australia

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Tasman Oncology Research

Southport, Queensland, Australia

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Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

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Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

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Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia

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Icon Cancer Centre Hobart

Hobart, Tasmania, Australia

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Box Hill Hospital

Box Hill, Victoria, Australia

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Monash Health

Clayton, Victoria, Australia

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Barwon Health

Geelong, Victoria, Australia

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Austin Health

Heidelberg, Victoria, Australia

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St Vincent's Hospital

Melbourne, Victoria, Australia

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Epworth Freemasons

Richmond, Victoria, Australia

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Fiona Stanley Hospital

Murdoch, Western Australia, Australia

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Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, Oost-Vlaanderen, Belgium

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UZ Gent

Ghent, Oost-Vlaanderen, Belgium

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AZ Groeninge Campus Kennedylaan

Kortrijk, West-Vlaanderen, Belgium

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CHU UCL Namur/Site Sainte Elisabeth

Namur, , Belgium

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Centro de Pesquisa Clínica do Instituto do Câncer do Ceará

Fortaleza, Ceará, Brazil

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Nucleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

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Centro Avançado de Tratamento Oncológico- CENANTRON

Belo Horizonte, Minas Gerais, Brazil

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Centro Integrado de Oncologia de Curitiba

Curitiba, Paraná, Brazil

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Hospital de Cancer de Londrina

Londrina, Paraná, Brazil

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Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

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Instituto de Oncologia Saint Gallen

Santa Cruz do Sul, Rio Grande do Sul, Brazil

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Clínica de Oncologia Reichow

Blumenau, Santa Catarina, Brazil

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Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

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Instituto de de Educação, pesquisa e Gestão em Saúde

Rio de Janeiro, , Brazil

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Instituto do Cancer Arnaldo Vieira de Carvalho

São Paulo, , Brazil

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Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, , Brazil

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Núcleo de Pesquisa Clínica da Rede São Camilo

São Paulo, , Brazil

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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Afflilated Hospital of Bengbu Medical College

Bengbu, Anhui, China

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Second Affiliated hospital of Anhui Medical University

Hefei, Anhui, China

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Wannan Medical College Yijishan Hospital

Wuhu, Anhui, China

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Beijing Hospital

Beijing, Beijing Municipality, China

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Peking University First Hospital

Beijing, Beijing Municipality, China

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Beijing Cancer hospital

Beijing, Beijing Municipality, China

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Sun Yat-Sen University Cancer Centre

Guangzhou, Guangdong, China

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Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, China

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Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

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Wuhan Union Hospital

Wuhan, Hubei, China

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Tongji Hospital Tongji Medical,Science & Technology

Wuhan, Hubei, China

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Hunan Provincial People's Hospital

Changsha, Hunan, China

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Xiangya Hospital Central South University

Changsha, Hunan, China

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Hunan Cancer Hospital

Changsha, Hunan, China

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Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

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The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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Jilin Cancer Hospital

Changchun, Jilin, China

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The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

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Yantai Yuhuangding Hospital

Yantai, Shandong, China

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

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Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

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Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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West China Hospital of Sichuan University

Chengdu, Sichuan, China

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Nanchong Central Hospital

Nanchong, Sichuan, China

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

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The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

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The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

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Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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Ningbo First Hospital

Ningbo, Zhejiang, China

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Nemocnice Horovice

Hořovice, Beroun, Czechia

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Masarykuv onkologicky ustav

Brno, Brno-město, Czechia

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Fakultni nemocnice Kralovske Vinohrady

Prague, Praha 10, Czechia

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Fakultni Thomayerova nemocnice

Prague, Praha 4, Czechia

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Oblastni nemocnice Pribram

Příbram, Příbram, Czechia

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Fakultni Nemocnice u sv. Anny v Brne

Brno, South Moravian, Czechia

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Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

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Urocentrum Praha

Prague, , Czechia

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Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

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Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

Brest, Brittany Region, France

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Polyclinique De Blois

La Chaussée-Saint-Victor, Centre-Val de Loire, France

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Centre Georges François Leclerc

Dijon, Côte-d'Or, France

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CHU Besançon

Besançon, Doubs, France

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Centre de Cancérologie du Grand Montpellier

Montpellier, Languedoc-Roussillon, France

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Hôpital privé du Confluent SAS

Nantes, Loire-Atlantique, France

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Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire-Atlantique, France

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Institut Paoli-Calmettes

Marseille, Provence-Alpes-Côte d'Azur Region, France

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Clinique Victor Hugo Le Mans

Le Mans, Sarthe, France

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Hôpital Européen Georges Pompidou

Paris, , France

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Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

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NCT

Heidelberg, Baden-Wurttemberg, Germany

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Studienpraxis Urologie

Nürtingen, Baden-Wurttemberg, Germany

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Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

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Universitaetsklinikum Tuebingen

Tübingen, Baden-Würt, Germany

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Klinikum Rechts Der Isar Der Technischen Universität München

Munich, Bavaria, Germany

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Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

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Urologicum Duisburg Fachärztesozietät - Walsum

Duisburg, North Rhine-Westphalia, Germany

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Urologische Gemeinschaftspraxis Heinsberg

Heinsberg, North Rhine-Westphalia, Germany

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Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, Germany

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Urologische Gemeinschaftspraxis Wesel

Wesel, North Rhine-Westphalia, Germany

Site Status

InVO Institut für Versorgungsforschung in der Onkologie

Koblenz, Rhineland-Palatinate, Germany

Site Status

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate, Germany

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Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

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Urologie Neandertal - Praxis Mettmann

Mettmann, , Germany

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Klinikum Nürnberg Nord

Nuremberg, , Germany

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University Hospital of Patras

Pátrai, Achaḯa, Greece

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Agios Savvas Regional Cancer Hospital

Athens, Attikí, Greece

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Alexandra Hospital

Athens, Attikí, Greece

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Attikon General University Hospital

Chaïdári, Attikí, Greece

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University General Hospital of Heraklion

Heraklion, Irakleío, Greece

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Bacs-Kiskun Megyei Korhaz

Kecskemét, Bács-Kiskun county, Hungary

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Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, Hungary

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Országos Onkológiai Intézet

Budapest, Pest County, Hungary

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Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , Hungary

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Meir Medical Center

Kfar Saba, Central District, Israel

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Rabin Medical Center

Petah Tikva, Central District, Israel

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Sheba Medical Center

Ramat Gan, Central District, Israel

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Yitzhak Shamir Medical Center

Ẕerifin, Central District, Israel

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Hadassah Medical Center

Jerusalem, Jerusalem, Israel

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Rambam Health Care Campus

Haifa, Northern District, Israel

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Sourasky Medical Center

Tel Aviv, Tell Abīb, Israel

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Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Emilia-Romagna, Italy

Site Status

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

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Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

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Istituto Oncologico Veneto IRCCS

Castelfranco Veneto, Veneto, Italy

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Istituto Europeo di Oncologia IRCCS

Milan, , Italy

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Azienda Ospedaliera Santa Maria Terni

Terni, , Italy

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APSS- Presidio Ospedaliero S. Chiara

Trento, , Italy

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Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

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National Cancer Center Hospital East

Kashiwa, Chiba, Japan

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Kimitsu Chuo Hospital

Kisarazu, Chiba, Japan

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Toho University Sakura Medical Center

Sakura, Chiba, Japan

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Hokkaido University Hospital

Sapporo, Hokkaido, Japan

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Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

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Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

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Kagawa University Hospital

Kita, Kagawa-ken, Japan

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Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

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Nagano Municipal Hospital

Tomitake, Nagano, Japan

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Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

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Showa University Hospital

Shinagawa, Tokyo, Japan

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National Hospital Organization Kumamoto Medical Center

Kumamoto, , Japan

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Osaka International Cancer Institute

Osaka, , Japan

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Osaka Metropolitan University Hospital

Osaka, , Japan

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Actualidad Basada en la Investigación del Cáncer

Guadalajara, Jalisco, Mexico

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Health Pharma Professional Research S.A. de C.V:

Mexico City, Mexico City, Mexico

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Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

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Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

Culiacán, Sinaloa, Mexico

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Scientia Investigacion Clinica S.C.

Chihuahua City, , Mexico

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Centro de Investigacion Clinica de Oaxaca

Oaxaca City, , Mexico

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ETZ Elisabeth

Tilburg, North Brabant, Netherlands

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University Medical Center Groningen

Groningen, , Netherlands

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Clinical Best Solutions

Lublin, Lublin Voivodeship, Poland

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Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

Opole, Opole Voivodeship, Poland

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Szpitale Pomorskie Sp. z o. o.

Gdynia, Pomeranian Voivodeship, Poland

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Salve Medica

Lodz, Łódź Voivodeship, Poland

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Provita Profamilia

Piotrkow Trybunalski, Łódź Voivodeship, Poland

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C.M.D.T.A. Neomed

Brasov, Brașov County, Romania

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Amethyst Radiotherapy Center

Florești, Cluj, Romania

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Ovidius Clinical Hospital OCH

Ovidiu, Constanța County, Romania

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Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania

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Radiology Therapeutic Center

Otopeni, Ilfov, Romania

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Oncopremium Team

Baia Mare, Maramureş, Romania

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SC Memorial Healthcare International SRL

Bucharest, , Romania

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Gral Medical Diagnostic Center

Bucharest, , Romania

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Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

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Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

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Instituto Catalan de Oncologia - Hospital Duran i Reynals

Hospitalet, Barcelona [Barcelona], Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Comunidad de, Spain

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Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

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Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

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Fundación Instituto Valenciano de Oncología

Valencia, Valenciana, Comunitat, Spain

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Hospital Infanta Cristina

Badajoz, , Spain

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Hospital Universitario Virgen Del Rocio

Seville, , Spain

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National Taiwan University Hospital

Taipei City, Taipei, Taiwan

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Taipei Veterans General Hospital

Taipei City, Taipei, Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, , Taiwan

Site Status

Medipol Mega Universite Hastanesi

Stanbul, Istanbul, Turkey (Türkiye)

Site Status

Izmir Medical Park Hospital

Izmir, Karsiyaka, İzmir, Turkey (Türkiye)

Site Status

Baskent University Dr. Turgut Noyan Research and Training Center

Adana, , Turkey (Türkiye)

Site Status

Ankara Bilkent Şehir Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Ankara Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Dicle Üniversitesi

Diyarbakır, , Turkey (Türkiye)

Site Status

Trakya University

Edirne, , Turkey (Türkiye)

Site Status

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

İnönü Üniversitesi Turgut Özal Tıp Merkezi

Malatya, , Turkey (Türkiye)

Site Status

Royal Blackburn Hospital

Blackburn, Blackburn With Darwen, United Kingdom

Site Status

Colchester General Hospital

Colchester, Essex, United Kingdom

Site Status

University College London Hospital

London, London, City of, United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Brazil Canada China Czechia France Germany Greece Hungary Israel Italy Japan Mexico Netherlands Poland Romania South Korea Spain Taiwan Turkey (Türkiye) United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://trials.lillytrialguide.com/en-US/trial/23jmzMPWglYwUwUN2GWvdM

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3)

Other Identifiers

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I3Y-MC-JPEG

Identifier Type: OTHER

Identifier Source: secondary_id

2022-500461-28-06

Identifier Type: OTHER

Identifier Source: secondary_id

18448

Identifier Type: -

Identifier Source: org_study_id

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