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Clinical Trials in South Korea / NCT04691804
Active, not recruiting Phase 3

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

NCT04691804 · tracked via the Priya Life Science South Korea tracker
Sponsor
Jiangsu HengRui Medicine Co., Ltd
Phase
Phase 3
Started
2021-03-18
Last updated
2024-12-31

Condition(s) studied

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Investigational drug(s) / intervention(s)

Fuzuloparib , Abiraterone acetate and Prednisone →Fuzuloparib Placebo， Abiraterone acetate and Prednisone

Fuzuloparib , Abiraterone acetate and Prednisone: 1. Fuzuloparib capsules (strength: 50 mg),150mg, Bid,po 2. Abiraterone acetate tablets (strength: 250 mg) 1000mg Qd,po 3. Prednisone tablets (strength: 5 mg) 5mg, Bid po

Fuzuloparib Placebo， Abiraterone acetate and Prednisone: 1. Fuzuloparib capsules Placebo (strength: 50 mg),150mg, Bid,po 2. Abiraterone acetate tablets (strength: 250 mg)1000mg Qd,po 3. Prednisone tablets (strength: 5 mg)5mg, Bid po

Study 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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria 1. Able and willing to provide a written informed consent 2. A score of 0 to 1 for ECOG performance status 3. Age of ≥ 18 years old 4. Prostate adenocarcinoma confirmed 5. Disease progression of metastatic prostate cancer while the subject was on androgen deprivation therapy. 6. The functional level of the organs must meet the requirements 7. Blood and tumor tissue samples are provided during screening to determine the DRD status Exclusion Criteria 1. Prior treatment with any PARP inhibitor 2. Have received any systemic anti-tumor treatment during the mCRPC stage or non-metastatic CRPC stage 3. Have used any CYP3A4 inducers or inhibitors within 14 days prior to the first dose 4. Plan to receive any other anti-tumor treatment 5. Presence of radiologically confirmed tumor lesions in the brain 6. Contraindications to the use of Prednisone 7. History of uncontrolled pituitary or adrenal dysfunction 8. Uncontrolled hypertension 9. Presence of active heart diseases 10. Human immunodeficiency virus-positive 11. Presence of dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption 12. Active HBV or HCV infection 13. Presence of concomitant diseases

Primary outcome measure(s)

  • rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3 — up to 3 years
    progression-free survival

Trial sites (147)

FacilityCityRegionStatus
Alaska Oncology and Hematology LLC Anchorage Alaska
Urological Associates of Southern Arizona PC Tucson Arizona
Desert Hematology Oncology Medical Group Inc Rancho Mirage California
San Bernardino Urological Associates Medical Group San Bernardino California
UF College of Medicine - Jacksonville Jacksonville Florida
Hematology Oncology Clinic Baton Rouge Louisiana
VA Maryland Health Care System Baltimore Maryland
Johns Hopkins Baltimore Maryland
Henry Ford Health System Detroit Michigan
GU Research Network LLC Omaha Nebraska
John Theurer Cancer Center Hackensack New Jersey
Weill Cornell Medicine New York New York
Messino Cancer Centers Asheville North Carolina
Gabrail Cancer Center Research Canton Ohio
Carolina Urologic Research Center, LLC Myrtle Beach South Carolina
Tennessee Oncology Chattanooga Tennessee
Center for Onology and Blood Disorders Houston Texas
Bendigo Health Bendigo Australia
Concord Repatriation General Hospital Concord Australia
St Vincents Hospital Melbourne Fitzroy Australia
Gosford Hospital Gosford Australia
Ashford Cancer Centre Research Kurralta Park Australia
The Alfred Hospital Melbourne Australia
Western Health St Albans Australia
Macquarie University Sydney Australia
Riverina Cancer Care Centre Wagga Wagga Australia
Sydney Adventist Hospital Wahroonga Australia
UZ Gent Ghent Belgium
Centre Hospitalier de Jolimont Haine-Saint-Paul Belgium
AZ Groeninge Kortrijk Belgium
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
Beijing cancer hospital Beijing China
Beijing Friendship Hospital Beijing China
Beijing Hospital Beijing China
Cancer hospital Chinese academy of medical science Beijing China
Hunan Cancer Hospital Changsha China
XiangYa hospital central south university Changsha China
Sichuan Provincial People's Hospital Chengdu China
West China Hospital of Sichuan University Chengdu China
Chongqing Cancer Hospital Chongqing China

+ 107 more sites — see the full list on the official registry below.

More Jiangsu HengRui Medicine Co., Ltd. trials in South Korea

A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS Recruiting
A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia (ExCIT) Recruiting

Other trials for the same condition

Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer Recruiting
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) Recruiting
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04691804 on ClinicalTrials.gov ↗ ← All trials in South Korea