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).
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
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There are 24 Locations for this study
Anchorage Alaska, 99508, United States More Info
Principal Investigator
Tucson Arizona, 85741, United States More Info
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Rancho Mirage California, 92270, United States More Info
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San Bernardino California, 92404, United States More Info
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Jacksonville Florida, 32209, United States More Info
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Baton Rouge Louisiana, 70809, United States More Info
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Baltimore Maryland, 21201, United States More Info
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Baltimore Maryland, 21287, United States More Info
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Detroit Michigan, 48202, United States More Info
Principal Investigator
Omaha Nebraska, 68130, United States More Info
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Hackensack New Jersey, 76011, United States More Info
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New York New York, 10021, United States More Info
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Asheville North Carolina, 28806, United States More Info
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Canton Ohio, 44718, United States
Myrtle Beach South Carolina, 29572, United States More Info
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Chattanooga Tennessee, 37404, United States More Info
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Houston Texas, 77030, United States
Concord , , Australia More Info
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Fitzroy , , Australia More Info
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Kurralta Park , , Australia More Info
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Wagga Wagga , , Australia More Info
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Haine Saint Paul , , Belgium More Info
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Shanghai Shanghai, , China More Info
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Beijing , , China More Info
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Changsha , , China More Info
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Chengdu , , China More Info
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Chengdu , , China More Info
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Chongqing , , China More Info
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Fuzhou , , China More Info
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Fuzhou , , China More Info
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Guangzhou , , China More Info
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Guangzhou , , China More Info
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Guiyang , , China More Info
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Ha'erbin , , China More Info
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Hangzhou , , China More Info
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Hangzhou , , China More Info
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Hefei , , China More Info
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Hefei , , China More Info
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Nanchang , , China More Info
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Nanchang , , China More Info
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Nanjing , , China More Info
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Shanghai , , China More Info
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Shanghai , , China More Info
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ShangHai , , China More Info
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Shijiazhuang , , China More Info
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Taiyuan , , China More Info
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Tianjin , , China More Info
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Tianjin , , China More Info
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Urumqi , , China More Info
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Urumqi , , China More Info
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Wenzhou , , China More Info
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Wuhan , , China More Info
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Wuhan , , China More Info
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WuXi , , China More Info
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Xi'an , , China More Info
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Xi'an , , China More Info
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Xuzhou , , China More Info
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YangZhou , , China More Info
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La Roche-sur-Yon , , France More Info
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Lille , , France More Info
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Nimes , , France More Info
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Paris , 75908, France More Info
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Saint-Herblain , , France More Info
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Strasbourg , , France More Info
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Toulouse , , France More Info
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Goyang , , Korea, Republic of More Info
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Seongnam , , Korea, Republic of More Info
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Seongnam , , Korea, Republic of More Info
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Seoul , , Korea, Republic of More Info
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Yangsan , , Korea, Republic of More Info
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Grudziadz , , Poland More Info
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Kobylniki , , Poland More Info
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Koszalin , , Poland More Info
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Warszawa , , Poland More Info
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Wroclaw , , Poland More Info
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Ivanovo , , Russian Federation More Info
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Moscow , , Russian Federation More Info
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Moscow , , Russian Federation More Info
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Omsk , , Russian Federation More Info
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Ufa , , Russian Federation More Info
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Castelló de la Plana Castellón, 12002, Spain More Info
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Barcelona , , Spain More Info
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Barcelona , , Spain More Info
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Córdoba , 14004, Spain More Info
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Girona , 17007, Spain More Info
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Madrid , , Spain More Info
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Madrid , , Spain More Info
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Madrid , , Spain More Info
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Málaga , 29017, Spain More Info
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Sevilla , , Spain More Info
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Valencia , , Spain More Info
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Kaohsiung , , Taiwan More Info
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Taichung , , Taiwan More Info
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Tainan , , Taiwan More Info
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Taipei , , Taiwan More Info
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Taoyuan , , Taiwan More Info
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London , , United Kingdom More Info
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London , , United Kingdom More Info
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London , , United Kingdom More Info
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Oxford , OX4 6, United Kingdom More Info
Principal Investigator
Sutton , , United Kingdom More Info
Principal Investigator
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