Prostate Cancer Clinical Trial

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

Summary

To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Able and willing to provide a written informed consent
A score of 0 to 1 for ECOG performance status
Age of ≥ 18 years old
Prostate adenocarcinoma confirmed
Disease progression of metastatic prostate cancer while the subject was on androgen deprivation therapy.
The functional level of the organs must meet the requirements
Blood and tumor tissue samples are provided during screening to determine the DRD status

Exclusion Criteria

Prior treatment with any PARP inhibitor
Have received any systemic anti-tumor treatment during the mCRPC stage or non-metastatic CRPC stage
Have used any CYP3A4 inducers or inhibitors within 14 days prior to the first dose
Plan to receive any other anti-tumor treatment
Presence of radiologically confirmed tumor lesions in the brain
Contraindications to the use of Prednisone
History of uncontrolled pituitary or adrenal dysfunction
Uncontrolled hypertension
Presence of active heart diseases
Human immunodeficiency virus-positive
Presence of dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption
Active HBV or HCV infection
Presence of concomitant diseases

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

804

Study ID:

NCT04691804

Recruitment Status:

Recruiting

Sponsor:

Jiangsu HengRui Medicine Co., Ltd.

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There are 24 Locations for this study

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Alaska Oncology and Hematology LLC
Anchorage Alaska, 99508, United States More Info
Steven Liu
Principal Investigator
Urological Associates of Southern Arizona PC
Tucson Arizona, 85741, United States More Info
Curtis Dunshee
Principal Investigator
Desert Hematology Oncology Medical Group Inc
Rancho Mirage California, 92270, United States More Info
Luke Dreisbach
Principal Investigator
San Bernardino Urological Associates Medical Group
San Bernardino California, 92404, United States More Info
Franklin Chu
Principal Investigator
UF College of Medicine - Jacksonville
Jacksonville Florida, 32209, United States More Info
KC Balaji
Principal Investigator
Hematology Oncology Clinic
Baton Rouge Louisiana, 70809, United States More Info
Michael Castine
Principal Investigator
VA Maryland Health Care System
Baltimore Maryland, 21201, United States More Info
Arif Hussain
Principal Investigator
Johns Hopkins
Baltimore Maryland, 21287, United States More Info
Channing Paller
Principal Investigator
Henry Ford Health System
Detroit Michigan, 48202, United States More Info
Clara Hwang
Principal Investigator
GU Research Network LLC
Omaha Nebraska, 68130, United States More Info
Luke Nordquist
Principal Investigator
John Theurer Cancer Center
Hackensack New Jersey, 76011, United States More Info
Robert Alter
Principal Investigator
Weill Cornell Medicine
New York New York, 10021, United States More Info
Cora Sternberg
Principal Investigator
Messino Cancer Centers
Asheville North Carolina, 28806, United States More Info
Christopher Chay
Principal Investigator
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
Carolina Urologic Research Center, LLC
Myrtle Beach South Carolina, 29572, United States More Info
Neal Shore
Principal Investigator
Tennessee Oncology
Chattanooga Tennessee, 37404, United States More Info
Edward Arrowsmith
Principal Investigator
Center for Onology and Blood Disorders
Houston Texas, 77030, United States
Bendigo Health
Bendigo , , Australia More Info
Robert Blum
Principal Investigator
Concord Repatriation General Hospital
Concord , , Australia More Info
Martin Stockler
Principal Investigator
St Vincents Hospital Melbourne
Fitzroy , , Australia More Info
Anthony Dowling
Principal Investigator
Gosford Hospital
Gosford , , Australia More Info
Matthew Chan
Principal Investigator
Ashford Cancer Centre Research
Kurralta Park , , Australia More Info
Francis Parnis
Principal Investigator
The Alfred Hospital
Melbourne , , Australia More Info
Mark Voskoboynik
Principal Investigator
Western Health
St Albans , , Australia More Info
Shirley Wong
Principal Investigator
Macquarie University
Sydney , , Australia More Info
Howard Gurney
Principal Investigator
Riverina Cancer Care Centre
Wagga Wagga , , Australia More Info
David Palmieri
Principal Investigator
Sydney Adventist Hospital
Wahroonga , , Australia More Info
Gavin Marx
Principal Investigator
UZ Gent
Gent , , Belgium More Info
Nicolaas Lumen
Principal Investigator
Centre Hospitalier de Jolimont
Haine Saint Paul , , Belgium More Info
Emmanuel Seront
Principal Investigator
AZ Groeninge
Kortrijk , , Belgium More Info
Karl Lesage
Principal Investigator
Fudan University Shanghai Cancer Center
Shanghai Shanghai, , China More Info
Dingwei Ye
Principal Investigator
Beijing cancer hospital
Beijing , , China More Info
Yong Yang
Principal Investigator
Beijing Friendship Hospital
Beijing , , China More Info
Ye Tian
Principal Investigator
Beijing Hospital
Beijing , , China More Info
Ben Wan
Principal Investigator
Cancer hospital Chinese academy of medical science
Beijing , , China More Info
Nianzeng Xing
Principal Investigator
Hunan Cancer Hospital
Changsha , , China More Info
Weiqing Han
Principal Investigator
XiangYa hospital central south university
Changsha , , China More Info
Mingfeng Chen
Principal Investigator
Sichuan Provincial People's Hospital
Chengdu , , China More Info
Mingxing Qiu
Principal Investigator
West China Hospital of Sichuan University
Chengdu , , China More Info
Lu Yang
Principal Investigator
Chongqing Cancer Hospital
Chongqing , , China More Info
Hong Luo
Principal Investigator
The First Affiliated Hospital of Chongqing Medical University
Chongqing , , China More Info
Xin Gou
Principal Investigator
Fujian Medical University Union Hospital
Fuzhou , , China More Info
Song Zheng
Principal Investigator
The First affiliatared hospital of Fujian medical university
Fuzhou , , China More Info
Xueyi Xue
Principal Investigator
Cancer Center, Sun Yat-sen University
Guangzhou , , China More Info
Fangjian Zhou
Principal Investigator
Sun Yet-Sen Memorial Hospital,Sun Yet-Sen University
Guangzhou , , China More Info
Hai Huang
Principal Investigator
Affiliated Hospital of Guizhou Medical University
Guiyang , , China More Info
Kaifa Tang
Principal Investigator
Guizhou Cancer Hospital
Guiyang , , China More Info
Benzhong Jia
Principal Investigator
Urology Ward 2,Harbin Medical University Cancer Hospital
Ha'erbin , , China More Info
Hui Chen
Principal Investigator
The First Affiliated Hospital,ZheJiang University School of Medicine
Hangzhou , , China More Info
Baiye Jin
Principal Investigator
ZheJiang Provincial People's Hospital
Hangzhou , , China More Info
Dahong Zhang
Principal Investigator
Anhui Provincial Hospital
Hefei , , China More Info
May Xiao
Principal Investigator
The First Affiliated Hospital Of Anhui Medical University
Hefei , , China More Info
Chaochao Liang
Principal Investigator
The Second Hospital Of Anhui Medical University
Hefei , , China More Info
Dexin Yu
Principal Investigator
The First Hospital of Jiaxing
Jiaxing , , China More Info
Yi He
Principal Investigator
Qilu Hospital of Shandong University
Jinan , , China More Info
Benkang Shi
Principal Investigator
Shandong Provincial Hospital
Jinan , , China More Info
Jiaju Lv
Principal Investigator
Yunnan Cancer Hospital
Kunming , , China More Info
Qilin Wang
Principal Investigator
The First Affiliated Hospital of Nanchang University
Nanchang , , China More Info
Ting Sat
Principal Investigator
The Second Affiliated Hospital of Nanchang University-DepartmentDepartment of Urology
Nanchang , , China More Info
Zimin Shi
Principal Investigator
JiangSu Cancer Hospital
NanJing , , China More Info
Qing Zou
Principal Investigator
Jiangsu Province Hospitall
NanJing , , China More Info
Lixin Hua
Principal Investigator
Nanjing Drum Tower Hospital
NanJing , , China More Info
Hongqian Guo
Principal Investigator
The first affiliated hospital of guangxi medical university
Nanjing , , China More Info
Jiwen Chen
Principal Investigator
ZhongDa hospital southeast university
Nanjing , , China More Info
Ming Chen
Principal Investigator
Qingdao Municipal Hospital
Qingdao , , China More Info
Sichuan Hou
Principal Investigator
Changhai Hospital of Shanghai-Department of Urology
Shanghai , , China More Info
Tie Zhou
Principal Investigator
Shanghai Tenth People's Hospital-Department of Urology
Shanghai , , China More Info
Xudong Yao
Principal Investigator
The Urology Surgery department of Zhongshan Hospital
ShangHai , , China More Info
Jianming Guo
Principal Investigator
Liaoning Cancer Hospital
Shenyang , , China More Info
Cheng Fu
Principal Investigator
The Fourth Hospital of Hebei Medical University
Shijiazhuang , , China More Info
Aili Zhang
Principal Investigator
First Hospital of Shanxi Medical University
Taiyuan , , China More Info
Xuhui Zhang
Principal Investigator
Shanxi Provincial Cancer Hospital
Taiyuan , , China More Info
Shuqing Wei
Principal Investigator
The Second Hospital Of TianJin medical University
Tianjin , , China More Info
Yong Wang
Principal Investigator
Tianjin Medical University Cancer Institute and Hospital
Tianjin , , China More Info
Xin Yao
Principal Investigator
The Affiliated Tumor Hospital of Xinjiang Medical University-Department of Urology
Urumqi , , China More Info
Peng Chen
Principal Investigator
The First Affiliated Hospital of Xinjiang Medical University
Urumqi , , China More Info
Xiareti Mulati
Principal Investigator
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , , China More Info
Zhixian Yu
Principal Investigator
Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology
Wuhan , , China More Info
Shaogang Wang
Principal Investigator
Union Hospital of Tongji Medical College,Huazhong University of Science and Technology
Wuhan , , China More Info
Xiaoping Zhang
Principal Investigator
Wuxi People's Hospital-Department of Urinary Surgery
WuXi , , China More Info
Qiang Hu
Principal Investigator
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an , , China More Info
Lei Li
Principal Investigator
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an , , China More Info
Tie Chong
Principal Investigator
The Affiliated Hospital of Xuzhou Medical University
Xuzhou , , China More Info
Junqi Wang
Principal Investigator
Northern Jiangsu People's Hospital
YangZhou , , China More Info
Guangcheng Zhou
Principal Investigator
Henan Cancer Hospital
Zhengzhou , , China More Info
Chaohong He
Principal Investigator
Henan Provincial People's Hospital
Zhengzhou , , China More Info
Degang Ding
Principal Investigator
Nemocnice Novy Jicin a.s.
Novy Jicin , , Czechia More Info
David Vrana
Principal Investigator
Thomayerova Nemocnice
Prague , , Czechia More Info
Tomas Buchler
Principal Investigator
Centre Hospitalier Departemental Vendee CHD
La Roche-sur-Yon , , France More Info
Frank Priou
Principal Investigator
CHRU de Lille Hopital Claude Huriez
Lille , , France More Info
Arnaud Villers
Principal Investigator
Centre Leon Berard
Lyon , , France More Info
Aude Flechon
Principal Investigator
Centre Hospitalier Universitaire de Nimes, Institut de Cancerologie du Gard
Nimes , , France More Info
Nadine Houede
Principal Investigator
Hopital Europeen George Pompidou
Paris , 75908, France More Info
Stephane Oudard
Principal Investigator
Hopital Lyon Sud
Pierre-Benite , , France More Info
Sophie Tartas
Principal Investigator
Centre Eugenie Marquis
Rennes , , France More Info
Brigitte Laguerre
Principal Investigator
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau
Saint-Herblain , , France More Info
Emmanuelle Bompas
Principal Investigator
Strasbourg Oncologie Liberale- Clinique Sainte Anne
Strasbourg , , France More Info
Youssef Tazi
Principal Investigator
Institut Univ du Cancer de Toulouse-Oncopole
Toulouse , , France More Info
Loic Mourey
Principal Investigator
National Institute of Oncology
Budapest , , Hungary More Info
Geczi Lajos
Principal Investigator
Semmelweis Egyetem
Budapest , , Hungary More Info
Nyirady Peter
Principal Investigator
Bekes Megyei Kozponti Korhaz
Gyula , , Hungary More Info
Piko Bela
Principal Investigator
BKMK Hospital
Kecskemét , , Hungary More Info
Kocsis Judit
Principal Investigator
Szent Borbala Korhaz
Tatabanya , , Hungary More Info
Uhlyarik Andrea
Principal Investigator
National Cancer Center
Goyang , , Korea, Republic of More Info
Jae Young Joung
Principal Investigator
CHA Bundang Medical Center CHA University
Seongnam , , Korea, Republic of More Info
Yong Moon
Principal Investigator
Seoul National University Bundang Hospital
Seongnam , , Korea, Republic of More Info
Sung Kyu Hong
Principal Investigator
Asan Medical Center
Seoul , , Korea, Republic of More Info
Jun Hyuk Hong
Principal Investigator
Seoul National University Hospital
Seoul , , Korea, Republic of More Info
Cheol Kwak
Principal Investigator
Severance Hospital
Seoul , , Korea, Republic of More Info
Young Deuk Choi
Principal Investigator
Pusan National University Yangsan Hospital
Yangsan , , Korea, Republic of More Info
Sung Woo Park
Principal Investigator
Szpitale Pomorskie Sp.zo.o
Gdynia , , Poland More Info
Iwona Danielewicz
Principal Investigator
Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego
Grudziadz , , Poland More Info
Urszula Sadowska
Principal Investigator
Clinical Research Center Sp. z o.o.
Kobylniki , , Poland More Info
Ilona Bar Letkiewicz
Principal Investigator
Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
Koszalin , , Poland More Info
Mariusz Kwiatkowski
Principal Investigator
University Hospital
Krakow , , Poland More Info
Piotr Wysocki
Principal Investigator
Szpital Kliniczny Nr Pozna?
Poznan , , Poland More Info
Piotr Tomczak
Principal Investigator
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie
Warszawa , , Poland More Info
Pawel Wiechno
Principal Investigator
Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center
Wroclaw , , Poland More Info
Krzysztof Tupikowski
Principal Investigator
Ivanovo Regional Oncology Dispensary
Ivanovo , , Russian Federation More Info
Semenov Andrey
Principal Investigator
Hertzen Moscow Oncology Research Center
Moscow , , Russian Federation More Info
Boris Alekseev
Principal Investigator
Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N. Blokhin
Moscow , , Russian Federation More Info
Vsevolod Matveev
Principal Investigator
Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
Omsk , , Russian Federation More Info
Evgeniy Kopyltsov
Principal Investigator
Bashkortostan Republican Clinical Oncology Dispensary
Ufa , , Russian Federation More Info
Sultanbaev Alexander
Principal Investigator
Hospital Provincial de Castellón
Castelló de la Plana Castellón, 12002, Spain More Info
David Lorente Estellés
Principal Investigator
Hospital del Mar
Barcelona , 08003, Spain More Info
Alejo Rodriguez-Vida
Principal Investigator
Hospital Clinico de Barcelona
Barcelona , , Spain More Info
Begona Mellado Gonzalez
Principal Investigator
Hospital Universitari Parc Tauli
Barcelona , , Spain More Info
Enrique Gallardo Diaz
Principal Investigator
Hospital Universitario Reina Sofía
Córdoba , 14004, Spain More Info
Maria José Méndez Vidal
Principal Investigator
Instituto Catalán de Oncología - Hospital Universitario Dr. Josep Trueta
Girona , 17007, Spain More Info
Núria Sala Gónzalez
Principal Investigator
Hospital Clinico Universitario San Carlos
Madrid , , Spain More Info
Javier Puente Vazquez
Principal Investigator
Hospital General Universitario Gregorio Marano
Madrid , , Spain More Info
Jose Angel Arranz Arija
Principal Investigator
Hospital Universitario 12 de Octubre
Madrid , , Spain More Info
Daniel Castellano
Principal Investigator
Hospital Universitario Virgen de la Victoria
Málaga , 29017, Spain More Info
María Isabel Sáez Medina
Principal Investigator
Hospital Universitario Virgen del Rocio
Sevilla , , Spain More Info
Begona Perez Valderrama
Principal Investigator
Fundacion Instituto Valenciano de Oncologia IVO
Valencia , , Spain More Info
Miguel Angel Climent Duran
Principal Investigator
Changhua Christian Hospital
Changhua , , Taiwan More Info
Pai-Fu Wang
Principal Investigator
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung , , Taiwan More Info
Wen-Jeng Wu
Principal Investigator
Tungs Taichung Metro Harbor Hospital
Taichung , , Taiwan More Info
Yen-Chuan Ou
Principal Investigator
Chi Mei Medical Center
Tainan , , Taiwan More Info
Kuan-Hua Huang
Principal Investigator
National Cheng Kung University Hospital
Tainan , , Taiwan More Info
Wen-Ping Su
Principal Investigator
National Taiwan University Hospital NTUH
Taipei , , Taiwan More Info
Yu-Chuan Lu
Principal Investigator
Chang Gung Memorial Hospital CGMH - Linkou Branch
Taoyuan , , Taiwan More Info
See-tong Pang
Principal Investigator
Imperial College Healthcare NHS Trust
London , , United Kingdom More Info
Naveed Sarwar
Principal Investigator
Sarah Cannon Research Institute UK
London , , United Kingdom More Info
Hendrik-Tobias Arkenau
Principal Investigator
University College London Hospital
London , , United Kingdom More Info
Ursula McGovern
Principal Investigator
Genesis Cancer Care-CHURCHILL Hospital Headington
Oxford , OX4 6, United Kingdom More Info
Andrew Protheroe
Principal Investigator
Royal Marsden Hospital
Sutton , , United Kingdom More Info
Angela Pathmanathan
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

804

Study ID:

NCT04691804

Recruitment Status:

Recruiting

Sponsor:


Jiangsu HengRui Medicine Co., Ltd.

How clear is this clinincal trial information?

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