Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04691804

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Bendigo Health, Bendigo, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fuzuloparib , Abiraterone acetate and Prednisone

Drug
  • Fuzuloparib capsules (strength: 50 mg),150mg, Bid,po
  • Abiraterone acetate tablets (strength: 250 mg) 1000mg Qd,po
  • Prednisone tablets (strength: 5 mg) 5mg, Bid po

Other names: SHR3162

Fuzuloparib Placebo， Abiraterone acetate and Prednisone

Drug
  • Fuzuloparib capsules Placebo (strength: 50 mg),150mg, Bid,po
  • Abiraterone acetate tablets (strength: 250 mg)1000mg Qd,po
  • Prednisone tablets (strength: 5 mg)5mg, Bid po

Primary outcomes

  1. rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3

    Time frame: up to 3 years

    progression-free survival

Secondary outcomes

  1. OS

    Time frame: up to 4 years

    time from randomization to death due to any cause

  2. ORR

    Time frame: up to 3 years

    The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

  3. Time to PSA progression

    Time frame: up to 3 years

    Time from randomisation to the first time of PSA progression according to the criterion of PCGW3

  4. Time to skeletal-related events

    Time frame: up to 4 years

    Time from randomisation to the first occurrence of a fracture or treatment for the fracture. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2020
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.