A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

496

Participants

Timeline

Start Date

March 18, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Interventions
DRUG

Fuzuloparib , Abiraterone acetate and Prednisone

"1. Fuzuloparib capsules (strength: 50 mg),150mg, Bid,po~2. Abiraterone acetate tablets (strength: 250 mg) 1000mg Qd,po~3. Prednisone tablets (strength: 5 mg) 5mg, Bid po"

DRUG

Fuzuloparib Placebo, Abiraterone acetate and Prednisone

"1. Fuzuloparib capsules Placebo (strength: 50 mg),150mg, Bid,po~2. Abiraterone acetate tablets (strength: 250 mg)1000mg Qd,po~3. Prednisone tablets (strength: 5 mg)5mg, Bid po"

Trial Locations (147)

10021

Weill Cornell Medicine, New York

12002

Hospital Provincial de Castellón, Castellon

14004

Hospital Universitario Reina Sofía, Córdoba

17007

Instituto Catalán de Oncología - Hospital Universitario Dr. Josep Trueta, Girona

21201

VA Maryland Health Care System, Baltimore

21287

Johns Hopkins, Baltimore

28806

Messino Cancer Centers, Asheville

29017

Hospital Universitario Virgen de la Victoria, Málaga

29572

Carolina Urologic Research Center, LLC, Myrtle Beach

32209

UF College of Medicine - Jacksonville, Jacksonville

37404

Tennessee Oncology, Chattanooga

44718

Gabrail Cancer Center Research, Canton

48202

Henry Ford Health System, Detroit

68130

GU Research Network LLC, Omaha

70809

Hematology Oncology Clinic, Baton Rouge

75908

Hopital Europeen George Pompidou, Paris

76011

John Theurer Cancer Center, Hackensack

77030

Center for Onology and Blood Disorders, Houston

85741

Urological Associates of Southern Arizona PC, Tucson

92270

Desert Hematology Oncology Medical Group Inc, Rancho Mirage

92404

San Bernardino Urological Associates Medical Group, San Bernardino

99508

Alaska Oncology and Hematology LLC, Anchorage

Unknown

Bendigo Health, Bendigo

Concord Repatriation General Hospital, Concord

St Vincents Hospital Melbourne, Fitzroy

Gosford Hospital, Gosford

Ashford Cancer Centre Research, Kurralta Park

The Alfred Hospital, Melbourne

Western Health, St Albans

Macquarie University, Sydney

Riverina Cancer Care Centre, Wagga Wagga

Sydney Adventist Hospital, Wahroonga

UZ Gent, Ghent

Centre Hospitalier de Jolimont, Haine-Saint-Paul

AZ Groeninge, Kortrijk

Fudan University Shanghai Cancer Center, Shanghai

Beijing cancer hospital, Beijing

Beijing Friendship Hospital, Beijing

Beijing Hospital, Beijing

Cancer hospital Chinese academy of medical science, Beijing

Hunan Cancer Hospital, Changsha

XiangYa hospital central south university, Changsha

Sichuan Provincial People's Hospital, Chengdu

West China Hospital of Sichuan University, Chengdu

Chongqing Cancer Hospital, Chongqing

The First Affiliated Hospital of Chongqing Medical University, Chongqing

Fujian Medical University Union Hospital, Fuzhou

The First affiliatared hospital of Fujian medical university, Fuzhou

Cancer Center, Sun Yat-sen University, Guangzhou

Sun Yet-Sen Memorial Hospital,Sun Yet-Sen University, Guangzhou

Affiliated Hospital of Guizhou Medical University, Guiyang

Guizhou Cancer Hospital, Guiyang

The First Affiliated Hospital,ZheJiang University School of Medicine, Hangzhou

ZheJiang Provincial People's Hospital, Hangzhou

Urology Ward 2,Harbin Medical University Cancer Hospital, Ha’erbin

Anhui Provincial Hospital, Hefei

The First Affiliated Hospital Of Anhui Medical University, Hefei

The Second Hospital Of Anhui Medical University, Hefei

The First Hospital of Jiaxing, Jiaxing

Qilu Hospital of Shandong University, Jinan

Shandong Provincial Hospital, Jinan

Yunnan Cancer Hospital, Kunming

The First Affiliated Hospital of Nanchang University, Nanchang

The Second Affiliated Hospital of Nanchang University-DepartmentDepartment of Urology, Nanchang

JiangSu Cancer Hospital, Nanjing

Jiangsu Province Hospitall, Nanjing

Nanjing Drum Tower Hospital, Nanjing

The first affiliated hospital of guangxi medical university, Nanjing

ZhongDa hospital southeast university, Nanjing

Qingdao Municipal Hospital, Qingdao

Changhai Hospital of Shanghai-Department of Urology, Shanghai

Shanghai Tenth People's Hospital-Department of Urology, Shanghai

The Urology Surgery department of Zhongshan Hospital, Shanghai

Liaoning Cancer Hospital, Shenyang

The Fourth Hospital of Hebei Medical University, Shijiazhuang

First Hospital of Shanxi Medical University, Taiyuan

Shanxi Provincial Cancer Hospital, Taiyuan

The Second Hospital Of TianJin medical University, Tianjin

Tianjin Medical University Cancer Institute and Hospital, Tianjin

The Affiliated Tumor Hospital of Xinjiang Medical University-Department of Urology, Ürümqi

The First Affiliated Hospital of Xinjiang Medical University, Ürümqi

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology, Wuhan

Union Hospital of Tongji Medical College,Huazhong University of Science and Technology, Wuhan

Wuxi People's Hospital-Department of Urinary Surgery, Wuxi

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

Northern Jiangsu People's Hospital, Yangzhou

Henan Cancer Hospital, Zhengzhou

Henan Provincial People's Hospital, Zhengzhou

Nemocnice Novy Jicin a.s., Nový Jičín

Thomayerova Nemocnice, Prague

Centre Hospitalier Departemental Vendee CHD, La Roche-sur-Yon

CHRU de Lille Hopital Claude Huriez, Lille

Centre Leon Berard, Lyon

Centre Hospitalier Universitaire de Nimes, Institut de Cancerologie du Gard, Nîmes

Hopital Lyon Sud, Pierre-Bénite

Centre Eugenie Marquis, Rennes

Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau, Saint-Herblain

Strasbourg Oncologie Liberale- Clinique Sainte Anne, Strasbourg

Institut Univ du Cancer de Toulouse-Oncopole, Toulouse

National Institute of Oncology, Budapest

Semmelweis Egyetem, Budapest

Bekes Megyei Kozponti Korhaz, Gyula

BKMK Hospital, Kecskemét

Szent Borbala Korhaz, Tatabánya

Szpitale Pomorskie Sp.zo.o, Gdynia

Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego, Grudziądz

Clinical Research Center Sp. z o.o., Kobylniki

Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika, Koszalin

University Hospital, Krakow

Szpital Kliniczny Nr Pozna?, Poznan

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie, Warsaw

Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center, Wroclaw

Ivanovo Regional Oncology Dispensary, Ivanovo

Hertzen Moscow Oncology Research Center, Moscow

Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N. Blokhin, Moscow

Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary, Omsk

Bashkortostan Republican Clinical Oncology Dispensary, Ufa

National Cancer Center, Goyang

CHA Bundang Medical Center CHA University, Seongnam

Seoul National University Bundang Hospital, Seongnam

Asan Medical Center, Seoul

Seoul National University Hospital, Seoul

Severance Hospital, Seoul

Pusan National University Yangsan Hospital, Yangsan

Hospital Clinico de Barcelona, Barcelona

Hospital Universitari Parc Tauli, Barcelona

Hospital Clinico Universitario San Carlos, Madrid

Hospital General Universitario Gregorio Marano, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario Virgen del Rocio, Seville

Fundacion Instituto Valenciano de Oncologia IVO, Valencia

Changhua Christian Hospital, Changhua

Kaohsiung Medical University - Chung-Ho Memorial Hospital, Kaohsiung City

Tungs Taichung Metro Harbor Hospital, Taichung

Chi Mei Medical Center, Tainan City

National Cheng Kung University Hospital, Tainan City

National Taiwan University Hospital NTUH, Taipei

Chang Gung Memorial Hospital CGMH - Linkou Branch, Taoyuan District

Imperial College Healthcare NHS Trust, London

Sarah Cannon Research Institute UK, London

University College London Hospital, London

Royal Marsden Hospital, Sutton

08003

Hospital del Mar, Barcelona

OX4 6LB

Genesis Cancer Care-CHURCHILL Hospital Headington, Oxford

All Listed Sponsors
lead

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY