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 UK 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 PrednisoneFuzuloparib 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

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)

Facility	City	Region
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.

Other trials for the same condition

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

Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors 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 the UK