Clinical trial NCT04691804: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-31
Enrollment: 496
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fuzuloparib Combined with Abiraterone Acetate and Prednisone (AA-P) versus Placebo Combined with AA-P
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

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

Primary outcomes:
measure: rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3
timeFrame: up to 3 years
Secondary outcomes:
measure: OS
timeFrame: up to 4 years
measure: ORR
timeFrame: up to 3 years
measure: Time to PSA progression
timeFrame: up to 3 years
measure: Time to skeletal-related events
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology LLC
state: Alaska
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona PC
state: Arizona
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group Inc
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates Medical Group
state: California
city: Jacksonville
country: United States
facility: UF College of Medicine - Jacksonville
state: Florida
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic
state: Louisiana
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Omaha
country: United States
facility: GU Research Network LLC
state: Nebraska
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Asheville
country: United States
facility: Messino Cancer Centers
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Houston
country: United States
facility: Center for Onology and Blood Disorders
state: Texas
city: Bendigo
country: Australia
facility: Bendigo Health
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne
city: Gosford
country: Australia
facility: Gosford Hospital
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: St Albans
country: Australia
facility: Western Health
city: Sydney
country: Australia
facility: Macquarie University
city: Wagga Wagga
country: Australia
facility: Riverina Cancer Care Centre
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
city: Gent
country: Belgium
facility: UZ Gent
city: Haine Saint Paul
country: Belgium
facility: Centre Hospitalier de Jolimont
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Beijing
country: China
facility: Beijing cancer hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Cancer hospital Chinese academy of medical science
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Changsha
country: China
facility: XiangYa hospital central south university
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Fuzhou
country: China
facility: The First affiliatared hospital of Fujian medical university
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
city: Guangzhou
country: China
facility: Sun Yet-Sen Memorial Hospital,Sun Yet-Sen University
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
city: Ha'erbin
country: China
facility: Urology Ward 2，Harbin Medical University Cancer Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital，ZheJiang University School of Medicine
city: Hangzhou
country: China
facility: ZheJiang Provincial People's Hospital
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital Of Anhui Medical University
city: Hefei
country: China
facility: The Second Hospital Of Anhui Medical University
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University-DepartmentDepartment of Urology
city: NanJing
country: China
facility: JiangSu Cancer Hospital
city: NanJing
country: China
facility: Jiangsu Province Hospitall
city: NanJing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: The first affiliated hospital of guangxi medical university
city: Nanjing
country: China
facility: ZhongDa hospital southeast university
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai-Department of Urology
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital-Department of Urology
city: ShangHai
country: China
facility: The Urology Surgery department of Zhongshan Hospital
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
city: Tianjin
country: China
facility: The Second Hospital Of TianJin medical University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Urumqi
country: China
facility: The Affiliated Tumor Hospital of Xinjiang Medical University-Department of Urology
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College,Huazhong University of Science and Technology
city: WuXi
country: China
facility: Wuxi People's Hospital-Department of Urinary Surgery
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
city: YangZhou
country: China
facility: Northern Jiangsu People's Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Novy Jicin
country: Czechia
facility: Nemocnice Novy Jicin a.s.
city: Prague
country: Czechia
facility: Thomayerova Nemocnice
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Departemental Vendee CHD
city: Lille
country: France
facility: CHRU de Lille Hopital Claude Huriez
city: Lyon
country: France
facility: Centre Leon Berard
city: Nimes
country: France
facility: Centre Hospitalier Universitaire de Nimes, Institut de Cancerologie du Gard
city: Paris
country: France
facility: Hopital Europeen George Pompidou
city: Pierre-Benite
country: France
facility: Hopital Lyon Sud
city: Rennes
country: France
facility: Centre Eugenie Marquis
city: Saint-Herblain
country: France
facility: Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau
city: Strasbourg
country: France
facility: Strasbourg Oncologie Liberale- Clinique Sainte Anne
city: Toulouse
country: France
facility: Institut Univ du Cancer de Toulouse-Oncopole
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Kecskemét
country: Hungary
facility: BKMK Hospital
city: Tatabanya
country: Hungary
facility: Szent Borbala Korhaz
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center CHA University
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp.zo.o
city: Grudziadz
country: Poland
facility: Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego
city: Kobylniki
country: Poland
facility: Clinical Research Center Sp. z o.o.
city: Koszalin
country: Poland
facility: Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
city: Krakow
country: Poland
facility: University Hospital
city: Poznan
country: Poland
facility: Szpital Kliniczny Nr Pozna?
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Hertzen Moscow Oncology Research Center
city: Moscow
country: Russian Federation
facility: Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N. Blokhin
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
city: Ufa
country: Russian Federation
facility: Bashkortostan Republican Clinical Oncology Dispensary
city: Castelló de la Plana
country: Spain
facility: Hospital Provincial de Castellón
state: Castellón
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinico de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Parc Tauli
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Girona
country: Spain
facility: Instituto Catalán de Oncología - Hospital Universitario Dr. Josep Trueta
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marano
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia IVO
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Tungs Taichung Metro Harbor Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital NTUH
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital CGMH - Linkou Branch
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
city: London
country: United Kingdom
facility: University College London Hospital
city: Oxford
country: United Kingdom
facility: Genesis Cancer Care-CHURCHILL Hospital Headington
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
References: