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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509396-16-00

Acronym

SHR3162-III-305

Enrollment

136

Registered

2024-03-19

Start date

2021-11-08

Completion date

Unknown

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Castration-Resistant Prostate Cancer

Brief summary

-Cohort 1: rPFS (assessed by Blinded Independent Central Review [BICR] according to RECIST 1.1 and PCWG3 criteria) in unselected mCRPC subjects. - Cohort 2: rPFS (assessed by Blinded Independent Central Review [BICR] according to RECIST 1.1 and PCWG3 criteria) in mCRPC subjects harboring DRD.

Detailed description

OS in unselected mCRPC subjects (Cohort 1) and in mCRPC subjects harboring DRD (Cohort 2), respectively.

Interventions

DRUGPlacebo

DRUGcapsule

DRUGFuzuloparib

DRUGPrednison acis 5 mg

DRUGTabletten

DRUGZYTIGA 500 mg film-coated tablets

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
-Cohort 1: rPFS (assessed by Blinded Independent Central Review [BICR] according to RECIST 1.1 and PCWG3 criteria) in unselected mCRPC subjects. - Cohort 2: rPFS (assessed by Blinded Independent Central Review [BICR] according to RECIST 1.1 and PCWG3 criteria) in mCRPC subjects harboring DRD.	—

Secondary

Measure	Time frame
OS in unselected mCRPC subjects (Cohort 1) and in mCRPC subjects harboring DRD (Cohort 2), respectively.	—

Countries

Belgium, Czechia, France, Hungary, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026