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
1 other identifier
interventional
496
13 countries
147
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2021
Longer than P75 for phase_3
147 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 31, 2020
CompletedStudy Start
First participant enrolled
March 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
December 31, 2024
December 1, 2024
5.8 years
December 30, 2020
December 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3
progression-free survival
up to 3 years
Secondary Outcomes (4)
OS
up to 4 years
ORR
up to 3 years
Time to PSA progression
up to 3 years
Time to skeletal-related events
up to 4 years
Study Arms (2)
Treatment group A
EXPERIMENTALFuzuloparib plus AA-P
Treatment group B
PLACEBO COMPARATORFuzuloparib Placebo plus AA-P
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (147)
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508, United States
Urological Associates of Southern Arizona PC
Tucson, Arizona, 85741, United States
Desert Hematology Oncology Medical Group Inc
Rancho Mirage, California, 92270, United States
San Bernardino Urological Associates Medical Group
San Bernardino, California, 92404, United States
UF College of Medicine - Jacksonville
Jacksonville, Florida, 32209, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809, United States
VA Maryland Health Care System
Baltimore, Maryland, 21201, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
GU Research Network LLC
Omaha, Nebraska, 68130, United States
John Theurer Cancer Center
Hackensack, New Jersey, 76011, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Messino Cancer Centers
Asheville, North Carolina, 28806, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572, United States
Tennessee Oncology
Chattanooga, Tennessee, 37404, United States
Center for Onology and Blood Disorders
Houston, Texas, 77030, United States
Bendigo Health
Bendigo, Australia
Concord Repatriation General Hospital
Concord, Australia
St Vincents Hospital Melbourne
Fitzroy, Australia
Gosford Hospital
Gosford, Australia
Ashford Cancer Centre Research
Kurralta Park, Australia
The Alfred Hospital
Melbourne, Australia
Western Health
St Albans, Australia
Macquarie University
Sydney, Australia
Riverina Cancer Care Centre
Wagga Wagga, Australia
Sydney Adventist Hospital
Wahroonga, Australia
UZ Gent
Ghent, Belgium
Centre Hospitalier de Jolimont
Haine-Saint-Paul, Belgium
AZ Groeninge
Kortrijk, Belgium
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Beijing cancer hospital
Beijing, China
Beijing Friendship Hospital
Beijing, China
Beijing Hospital
Beijing, China
Cancer hospital Chinese academy of medical science
Beijing, China
Hunan Cancer Hospital
Changsha, China
XiangYa hospital central south university
Changsha, China
Sichuan Provincial People's Hospital
Chengdu, China
West China Hospital of Sichuan University
Chengdu, China
Chongqing Cancer Hospital
Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Fujian Medical University Union Hospital
Fuzhou, China
The First affiliatared hospital of Fujian medical university
Fuzhou, China
Cancer Center, Sun Yat-sen University
Guangzhou, China
Sun Yet-Sen Memorial Hospital,Sun Yet-Sen University
Guangzhou, China
Affiliated Hospital of Guizhou Medical University
Guiyang, China
Guizhou Cancer Hospital
Guiyang, China
The First Affiliated Hospital，ZheJiang University School of Medicine
Hangzhou, China
ZheJiang Provincial People's Hospital
Hangzhou, China
Urology Ward 2，Harbin Medical University Cancer Hospital
Ha’erbin, China
Anhui Provincial Hospital
Hefei, China
The First Affiliated Hospital Of Anhui Medical University
Hefei, China
The Second Hospital Of Anhui Medical University
Hefei, China
The First Hospital of Jiaxing
Jiaxing, China
Qilu Hospital of Shandong University
Jinan, China
Shandong Provincial Hospital
Jinan, China
Yunnan Cancer Hospital
Kunming, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
The Second Affiliated Hospital of Nanchang University-DepartmentDepartment of Urology
Nanchang, China
JiangSu Cancer Hospital
Nanjing, China
Jiangsu Province Hospitall
Nanjing, China
Nanjing Drum Tower Hospital
Nanjing, China
The first affiliated hospital of guangxi medical university
Nanjing, China
ZhongDa hospital southeast university
Nanjing, China
Qingdao Municipal Hospital
Qingdao, China
Changhai Hospital of Shanghai-Department of Urology
Shanghai, China
Shanghai Tenth People's Hospital-Department of Urology
Shanghai, China
The Urology Surgery department of Zhongshan Hospital
Shanghai, China
Liaoning Cancer Hospital
Shenyang, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
First Hospital of Shanxi Medical University
Taiyuan, China
Shanxi Provincial Cancer Hospital
Taiyuan, China
The Second Hospital Of TianJin medical University
Tianjin, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
The Affiliated Tumor Hospital of Xinjiang Medical University-Department of Urology
Ürümqi, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology
Wuhan, China
Union Hospital of Tongji Medical College,Huazhong University of Science and Technology
Wuhan, China
Wuxi People's Hospital-Department of Urinary Surgery
Wuxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Northern Jiangsu People's Hospital
Yangzhou, China
Henan Cancer Hospital
Zhengzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
Nemocnice Novy Jicin a.s.
Nový Jičín, Czechia
Thomayerova Nemocnice
Prague, Czechia
Centre Hospitalier Departemental Vendee CHD
La Roche-sur-Yon, France
CHRU de Lille Hopital Claude Huriez
Lille, France
Centre Leon Berard
Lyon, France
Centre Hospitalier Universitaire de Nimes, Institut de Cancerologie du Gard
Nîmes, France
Hopital Europeen George Pompidou
Paris, 75908, France
Hopital Lyon Sud
Pierre-Bénite, France
Centre Eugenie Marquis
Rennes, France
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau
Saint-Herblain, France
Strasbourg Oncologie Liberale- Clinique Sainte Anne
Strasbourg, France
Institut Univ du Cancer de Toulouse-Oncopole
Toulouse, France
National Institute of Oncology
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Bekes Megyei Kozponti Korhaz
Gyula, Hungary
BKMK Hospital
Kecskemét, Hungary
Szent Borbala Korhaz
Tatabánya, Hungary
Szpitale Pomorskie Sp.zo.o
Gdynia, Poland
Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego
Grudziądz, Poland
Clinical Research Center Sp. z o.o.
Kobylniki, Poland
Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
Koszalin, Poland
University Hospital
Krakow, Poland
Szpital Kliniczny Nr Pozna?
Poznan, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie
Warsaw, Poland
Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center
Wroclaw, Poland
Ivanovo Regional Oncology Dispensary
Ivanovo, Russia
Hertzen Moscow Oncology Research Center
Moscow, Russia
Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, Russia
Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
Omsk, Russia
Bashkortostan Republican Clinical Oncology Dispensary
Ufa, Russia
National Cancer Center
Goyang, South Korea
CHA Bundang Medical Center CHA University
Seongnam, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Hospital Provincial de Castellón
Castellon, Castellón, 12002, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Clinico de Barcelona
Barcelona, Spain
Hospital Universitari Parc Tauli
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Instituto Catalán de Oncología - Hospital Universitario Dr. Josep Trueta
Girona, 17007, Spain
Hospital Clinico Universitario San Carlos
Madrid, Spain
Hospital General Universitario Gregorio Marano
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29017, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Fundacion Instituto Valenciano de Oncologia IVO
Valencia, Spain
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Tungs Taichung Metro Harbor Hospital
Taichung, Taiwan
Chi Mei Medical Center
Tainan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital NTUH
Taipei, Taiwan
Chang Gung Memorial Hospital CGMH - Linkou Branch
Taoyuan District, Taiwan
Imperial College Healthcare NHS Trust
London, United Kingdom
Sarah Cannon Research Institute UK
London, United Kingdom
University College London Hospital
London, United Kingdom
Genesis Cancer Care-CHURCHILL Hospital Headington
Oxford, OX4 6LB, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2020
First Posted
December 31, 2020
Study Start
March 18, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
December 31, 2024
Record last verified: 2024-12