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Trial 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).

Acronym:

FUZOPRO

ACTRN/NCT /ethics:

NCT04691804

Scientific 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

Sponsor / Cooperative group:

Jiangsu HengRui Medicine Co., Ltd

Trial & Patient Characteristics

Cancer TypeProstate
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexMale
Tumour Stream -
Cancer StageMetastatic or Widespread
Anticipated Start Date2021-03-21
Anticipated End Date2026-12-31

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Francis Parnis
Recruitment StatusNot Yet Recruiting