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
- Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Interventions
- Drug: Fuzuloparib PlaceboοΌ Abiraterone acetate and PrednisoneDrug: Fuzuloparib , Abiraterone acetate and Prednisone
- Registration Number
- NCT04691804
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 496
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group B Fuzuloparib PlaceboοΌ Abiraterone acetate and Prednisone Fuzuloparib Placebo plus AA-P Treatment group A Fuzuloparib , Abiraterone acetate and Prednisone Fuzuloparib plus AA-P
- Primary Outcome Measures
Name Time Method rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3 up to 3 years progression-free survival
- Secondary Outcome Measures
Name Time Method ORR up to 3 years The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Time to PSA progression up to 3 years Time from randomisation to the first time of PSA progression according to the criterion of PCGW3
OS up to 4 years time from randomization to death due to any cause
Time to skeletal-related events up to 4 years Time from randomisation to the first occurrence of a fracture or treatment for the fracture. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery.
Trial Locations
- Locations (147)
The Second Affiliated Hospital of Xi'an Jiaotong University
π¨π³Xi'an, China
The Affiliated Hospital of Xuzhou Medical University
π¨π³Xuzhou, China
Northern Jiangsu People's Hospital
π¨π³YangZhou, China
Henan Cancer Hospital
π¨π³Zhengzhou, China
Henan Provincial People's Hospital
π¨π³Zhengzhou, China
Nemocnice Novy Jicin a.s.
π¨πΏNovy Jicin, Czechia
Thomayerova Nemocnice
π¨πΏPrague, Czechia
Centre Hospitalier Departemental Vendee CHD
π«π·La Roche-sur-Yon, France
CHRU de Lille Hopital Claude Huriez
π«π·Lille, France
Centre Leon Berard
π«π·Lyon, France
Centre Hospitalier Universitaire de Nimes, Institut de Cancerologie du Gard
π«π·Nimes, France
Hopital Europeen George Pompidou
π«π·Paris, France
Hopital Lyon Sud
π«π·Pierre-Benite, France
Centre Eugenie Marquis
π«π·Rennes, France
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau
π«π·Saint-Herblain, France
Strasbourg Oncologie Liberale- Clinique Sainte Anne
π«π·Strasbourg, France
Institut Univ du Cancer de Toulouse-Oncopole
π«π·Toulouse, France
National Institute of Oncology
ππΊBudapest, Hungary
Semmelweis Egyetem
ππΊBudapest, Hungary
Bekes Megyei Kozponti Korhaz
ππΊGyula, Hungary
BKMK Hospital
ππΊKecskemΓ©t, Hungary
Szent Borbala Korhaz
ππΊTatabanya, Hungary
National Cancer Center
π°π·Goyang, Korea, Republic of
CHA Bundang Medical Center CHA University
π°π·Seongnam, Korea, Republic of
Seoul National University Bundang Hospital
π°π·Seongnam, Korea, Republic of
Asan Medical Center
π°π·Seoul, Korea, Republic of
Seoul National University Hospital
π°π·Seoul, Korea, Republic of
Severance Hospital
π°π·Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
π°π·Yangsan, Korea, Republic of
Szpitale Pomorskie Sp.zo.o
π΅π±Gdynia, Poland
Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego
π΅π±Grudziadz, Poland
Clinical Research Center Sp. z o.o.
π΅π±Kobylniki, Poland
Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
π΅π±Koszalin, Poland
University Hospital
π΅π±Krakow, Poland
Szpital Kliniczny Nr Pozna?
π΅π±Poznan, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie
π΅π±Warszawa, Poland
Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center
π΅π±Wroclaw, Poland
Ivanovo Regional Oncology Dispensary
π·πΊIvanovo, Russian Federation
Hertzen Moscow Oncology Research Center
π·πΊMoscow, Russian Federation
Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N. Blokhin
π·πΊMoscow, Russian Federation
Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
π·πΊOmsk, Russian Federation
Bashkortostan Republican Clinical Oncology Dispensary
π·πΊUfa, Russian Federation
Hospital Provincial de CastellΓ³n
πͺπΈCastellΓ³ de la Plana, CastellΓ³n, Spain
Hospital del Mar
πͺπΈBarcelona, Spain
Hospital Clinico de Barcelona
πͺπΈBarcelona, Spain
Hospital Universitari Parc Tauli
πͺπΈBarcelona, Spain
Hospital Universitario Reina SofΓa
πͺπΈCΓ³rdoba, Spain
Instituto CatalΓ‘n de OncologΓa - Hospital Universitario Dr. Josep Trueta
πͺπΈGirona, Spain
Hospital Clinico Universitario San Carlos
πͺπΈMadrid, Spain
Hospital General Universitario Gregorio Marano
πͺπΈMadrid, Spain
Hospital Universitario 12 de Octubre
πͺπΈMadrid, Spain
Hospital Universitario Virgen de la Victoria
πͺπΈMΓ‘laga, Spain
Hospital Universitario Virgen del Rocio
πͺπΈSevilla, Spain
Fundacion Instituto Valenciano de Oncologia IVO
πͺπΈValencia, Spain
Changhua Christian Hospital
π¨π³Changhua, Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital
π¨π³Kaohsiung, Taiwan
Tungs Taichung Metro Harbor Hospital
π¨π³Taichung, Taiwan
Chi Mei Medical Center
π¨π³Tainan, Taiwan
National Cheng Kung University Hospital
π¨π³Tainan, Taiwan
National Taiwan University Hospital NTUH
π¨π³Taipei, Taiwan
Chang Gung Memorial Hospital CGMH - Linkou Branch
π¨π³Taoyuan, Taiwan
Imperial College Healthcare NHS Trust
π¬π§London, United Kingdom
Sarah Cannon Research Institute UK
π¬π§London, United Kingdom
University College London Hospital
π¬π§London, United Kingdom
Genesis Cancer Care-CHURCHILL Hospital Headington
π¬π§Oxford, United Kingdom
Royal Marsden Hospital
π¬π§Sutton, United Kingdom
Alaska Oncology and Hematology LLC
πΊπΈAnchorage, Alaska, United States
Urological Associates of Southern Arizona PC
πΊπΈTucson, Arizona, United States
Desert Hematology Oncology Medical Group Inc
πΊπΈRancho Mirage, California, United States
San Bernardino Urological Associates Medical Group
πΊπΈSan Bernardino, California, United States
UF College of Medicine - Jacksonville
πΊπΈJacksonville, Florida, United States
Hematology Oncology Clinic
πΊπΈBaton Rouge, Louisiana, United States
VA Maryland Health Care System
πΊπΈBaltimore, Maryland, United States
Johns Hopkins
πΊπΈBaltimore, Maryland, United States
Henry Ford Health System
πΊπΈDetroit, Michigan, United States
GU Research Network LLC
πΊπΈOmaha, Nebraska, United States
John Theurer Cancer Center
πΊπΈHackensack, New Jersey, United States
Weill Cornell Medicine
πΊπΈNew York, New York, United States
Messino Cancer Centers
πΊπΈAsheville, North Carolina, United States
Gabrail Cancer Center Research
πΊπΈCanton, Ohio, United States
Carolina Urologic Research Center, LLC
πΊπΈMyrtle Beach, South Carolina, United States
Tennessee Oncology
πΊπΈChattanooga, Tennessee, United States
Center for Onology and Blood Disorders
πΊπΈHouston, Texas, United States
Bendigo Health
π¦πΊBendigo, Australia
Concord Repatriation General Hospital
π¦πΊConcord, Australia
St Vincents Hospital Melbourne
π¦πΊFitzroy, Australia
Gosford Hospital
π¦πΊGosford, Australia
Ashford Cancer Centre Research
π¦πΊKurralta Park, Australia
The Alfred Hospital
π¦πΊMelbourne, Australia
Western Health
π¦πΊSt Albans, Australia
Macquarie University
π¦πΊSydney, Australia
Riverina Cancer Care Centre
π¦πΊWagga Wagga, Australia
Sydney Adventist Hospital
π¦πΊWahroonga, Australia
UZ Gent
π§πͺGent, Belgium
Centre Hospitalier de Jolimont
π§πͺHaine Saint Paul, Belgium
AZ Groeninge
π§πͺKortrijk, Belgium
Fudan University Shanghai Cancer Center
π¨π³Shanghai, Shanghai, China
Beijing cancer hospital
π¨π³Beijing, China
Beijing Friendship Hospital
π¨π³Beijing, China
Beijing Hospital
π¨π³Beijing, China
Cancer hospital Chinese academy of medical science
π¨π³Beijing, China
Hunan Cancer Hospital
π¨π³Changsha, China
XiangYa hospital central south university
π¨π³Changsha, China
Sichuan Provincial People's Hospital
π¨π³Chengdu, China
West China Hospital of Sichuan University
π¨π³Chengdu, China
Chongqing Cancer Hospital
π¨π³Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
π¨π³Chongqing, China
Fujian Medical University Union Hospital
π¨π³Fuzhou, China
The First affiliatared hospital of Fujian medical university
π¨π³Fuzhou, China
Cancer Center, Sun Yat-sen University
π¨π³Guangzhou, China
Sun Yet-Sen Memorial Hospital,Sun Yet-Sen University
π¨π³Guangzhou, China
Affiliated Hospital of Guizhou Medical University
π¨π³Guiyang, China
Guizhou Cancer Hospital
π¨π³Guiyang, China
Urology Ward 2οΌHarbin Medical University Cancer Hospital
π¨π³Ha'erbin, China
The First Affiliated HospitalοΌZheJiang University School of Medicine
π¨π³Hangzhou, China
ZheJiang Provincial People's Hospital
π¨π³Hangzhou, China
Anhui Provincial Hospital
π¨π³Hefei, China
The First Affiliated Hospital Of Anhui Medical University
π¨π³Hefei, China
The Second Hospital Of Anhui Medical University
π¨π³Hefei, China
The First Hospital of Jiaxing
π¨π³Jiaxing, China
Qilu Hospital of Shandong University
π¨π³Jinan, China
Shandong Provincial Hospital
π¨π³Jinan, China
Yunnan Cancer Hospital
π¨π³Kunming, China
The First Affiliated Hospital of Nanchang University
π¨π³Nanchang, China
The Second Affiliated Hospital of Nanchang University-DepartmentDepartment of Urology
π¨π³Nanchang, China
JiangSu Cancer Hospital
π¨π³NanJing, China
Jiangsu Province Hospitall
π¨π³NanJing, China
Nanjing Drum Tower Hospital
π¨π³NanJing, China
The first affiliated hospital of guangxi medical university
π¨π³Nanjing, China
ZhongDa hospital southeast university
π¨π³Nanjing, China
Qingdao Municipal Hospital
π¨π³Qingdao, China
Changhai Hospital of Shanghai-Department of Urology
π¨π³Shanghai, China
Shanghai Tenth People's Hospital-Department of Urology
π¨π³Shanghai, China
The Urology Surgery department of Zhongshan Hospital
π¨π³ShangHai, China
Liaoning Cancer Hospital
π¨π³Shenyang, China
The Fourth Hospital of Hebei Medical University
π¨π³Shijiazhuang, China
First Hospital of Shanxi Medical University
π¨π³Taiyuan, China
Shanxi Provincial Cancer Hospital
π¨π³Taiyuan, China
The Second Hospital Of TianJin medical University
π¨π³Tianjin, China
Tianjin Medical University Cancer Institute and Hospital
π¨π³Tianjin, China
The Affiliated Tumor Hospital of Xinjiang Medical University-Department of Urology
π¨π³Urumqi, China
The First Affiliated Hospital of Xinjiang Medical University
π¨π³Urumqi, China
The First Affiliated Hospital of Wenzhou Medical University
π¨π³Wenzhou, China
Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology
π¨π³Wuhan, China
Union Hospital of Tongji Medical College,Huazhong University of Science and Technology
π¨π³Wuhan, China
Wuxi People's Hospital-Department of Urinary Surgery
π¨π³WuXi, China
The First Affiliated Hospital of Xi'an Jiaotong University
π¨π³Xi'an, China