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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    804
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 29 May 2022

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).

Details
Condition Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Treatment Fuzuloparib , Abiraterone acetate and Prednisone, Fuzuloparib Placebo, Abiraterone acetate and Prednisone
Clinical Study IdentifierNCT04691804
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

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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