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).

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• Intervention / Treatment: Drug: Fuzuloparib , Abiraterone acetate and Prednisone; Drug: Fuzuloparib Placebo， Abiraterone acetate and Prednisone

• Study Type: Interventional
• Enrollment (Actual): 496
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Bendigo, Australia
    • Bendigo Health
  • Concord, Australia
    • Concord Repatriation General Hospital
  • Fitzroy, Australia
    • St Vincents Hospital Melbourne
  • Gosford, Australia
    • Gosford Hospital
  • Kurralta Park, Australia
    • Ashford Cancer Centre Research
  • Melbourne, Australia
    • The Alfred Hospital
  • St Albans, Australia
    • Western Health
  • Sydney, Australia
    • Macquarie University
  • Wagga Wagga, Australia
    • Riverina Cancer Care Centre
  • Wahroonga, Australia
    • Sydney Adventist Hospital
• Belgium
  • Gent, Belgium
    • UZ Gent
  • Haine Saint Paul, Belgium
    • Centre Hospitalier de Jolimont
  • Kortrijk, Belgium
    • AZ Groeninge
• China
  • Beijing, China
    • Beijing Cancer Hospital
  • Beijing, China
    • Beijing Hospital
  • Beijing, China
    • Cancer Hospital Chinese Academy of Medical Science
  • Beijing, China
    • Beijing Friendship Hospital
  • Changsha, China
    • Xiangya Hospital Central South University
  • Changsha, China
    • Hunan Cancer Hospital
  • Chengdu, China
    • Sichuan Provincial People's Hospital
  • Chengdu, China
    • West China Hospital of Sichuan University
  • Chongqing, China
    • The First Affiliated Hospital of Chongqing Medical University
  • Chongqing, China
    • Chongqing Cancer Hospital
  • Fuzhou, China
    • Fujian Medical University Union Hospital
  • Fuzhou, China
    • The First affiliatared hospital of Fujian medical university
  • Guangzhou, China
    • Cancer Center, Sun Yat-sen University
  • Guangzhou, China
    • Sun Yet-Sen Memorial Hospital,Sun Yet-Sen University
  • Guiyang, China
    • Guizhou Cancer Hospital
  • Guiyang, China
    • Affiliated Hospital of Guizhou Medical University
  • Ha'erbin, China
    • Urology Ward 2，Harbin Medical University Cancer Hospital
  • Hangzhou, China
    • Zhejiang Provincial People's Hospital
  • Hangzhou, China
    • The First Affiliated Hospital，Zhejiang University School of Medicine
  • Hefei, China
    • The First Affiliated Hospital of Anhui Medical University
  • Hefei, China
    • Anhui Provincial Hospital
  • Hefei, China
    • The Second Hospital of Anhui Medical University
  • Jiaxing, China
    • The First Hospital of Jiaxing
  • Jinan, China
    • Shandong Provincial Hospital
  • Jinan, China
    • Qilu Hospital of Shandong University
  • Kunming, China
    • Yunnan Cancer Hospital
  • NanJing, China
    • Jiangsu Cancer Hospital
  • NanJing, China
    • Jiangsu Province Hospitall
  • NanJing, China
    • Nanjing Drum Tower Hospital
  • Nanchang, China
    • The First Affiliated Hospital of Nanchang University
  • Nanchang, China
    • The Second Affiliated Hospital of Nanchang University-DepartmentDepartment of Urology
  • Nanjing, China
    • Zhongda Hospital Southeast University
  • Nanjing, China
    • The First Affiliated Hospital of Guangxi Medical University
  • Qingdao, China
    • Qingdao Municipal Hospital
  • ShangHai, China
    • The Urology Surgery department of Zhongshan Hospital
  • Shanghai, China
    • Changhai Hospital of Shanghai-Department of Urology
  • Shanghai, China
    • Shanghai Tenth People's Hospital-Department of Urology
  • Shenyang, China
    • Liaoning Cancer Hospital
  • Shijiazhuang, China
    • The Fourth Hospital of Hebei Medical University
  • Taiyuan, China
    • First Hospital of Shanxi Medical University
  • Taiyuan, China
    • Shanxi Provincial Cancer Hospital
  • Tianjin, China
    • Tianjin Medical University Cancer Institute and Hospital
  • Tianjin, China
    • The Second Hospital of Tianjin Medical University
  • Urumqi, China
    • The First Affiliated Hospital of Xinjiang Medical University
  • Urumqi, China
    • The Affiliated Tumor Hospital of Xinjiang Medical University-Department of Urology
  • Wenzhou, China
    • The First Affiliated Hospital of Wenzhou Medical University
  • WuXi, China
    • Wuxi People's Hospital-Department of Urinary Surgery
  • Wuhan, China
    • Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology
  • Wuhan, China
    • Union Hospital of Tongji Medical College,Huazhong University of Science and Technology
  • Xi'an, China
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Xi'an, China
    • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Xuzhou, China
    • The Affiliated Hospital of Xuzhou Medical University
  • YangZhou, China
    • Northern Jiangsu People's Hospital
  • Zhengzhou, China
    • Henan Provincial People's Hospital
  • Zhengzhou, China
    • Henan Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Fudan University Shanghai Cancer Center
• Czechia
  • Novy Jicin, Czechia
    • Nemocnice Novy Jicin a.s.
  • Prague, Czechia
    • Thomayerova nemocnice
• France
  • La Roche-sur-Yon, France
    • Centre Hospitalier Departemental Vendee CHD
  • Lille, France
    • CHRU de Lille Hopital Claude Huriez
  • Lyon, France
    • Centre Leon Berard
  • Nimes, France
    • Centre Hospitalier Universitaire de Nîmes, Institut de Cancérologie du GARD
  • Paris, France, 75908
    • Hôpital Européen George Pompidou
  • Pierre-Benite, France
    • Hôpital Lyon Sud
  • Rennes, France
    • Centre Eugenie Marquis
  • Saint-Herblain, France
    • Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau
  • Strasbourg, France
    • Strasbourg Oncologie Liberale- Clinique Sainte Anne
  • Toulouse, France
    • Institut Univ du Cancer de Toulouse-Oncopole
• Hungary
  • Budapest, Hungary
    • Semmelweis Egyetem
  • Budapest, Hungary
    • National Institute of Oncology
  • Gyula, Hungary
    • Békés Megyei Központi Kórház
  • Kecskemét, Hungary
    • Bkmk Hospital
  • Tatabanya, Hungary
    • Szent Borbala Korhaz
• Korea, Republic of
  • Goyang, Korea, Republic of
    • National Cancer Center
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seongnam, Korea, Republic of
    • CHA Bundang Medical Center CHA University
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Yangsan, Korea, Republic of
    • Pusan National University Yangsan Hospital
• Poland
  • Gdynia, Poland
    • Szpitale Pomorskie Sp.zo.o
  • Grudziadz, Poland
    • Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego
  • Kobylniki, Poland
    • Clinical Research Center Sp. z o.o.
  • Koszalin, Poland
    • Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
  • Krakow, Poland
    • University Hospital
  • Poznan, Poland
    • Szpital Kliniczny Nr Pozna?
  • Warszawa, Poland
    • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie
  • Wroclaw, Poland
    • Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center
• Russian Federation
  • Ivanovo, Russian Federation
    • Ivanovo regional oncology dispensary
  • Moscow, Russian Federation
    • Hertzen Moscow Oncology Research Center
  • Moscow, Russian Federation
    • Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N. Blokhin
  • Omsk, Russian Federation
    • Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
  • Ufa, Russian Federation
    • Bashkortostan Republican Clinical Oncology Dispensary
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain
    • Hospital Clínico de Barcelona
  • Barcelona, Spain
    • Hospital Universitari Parc Tauli
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Girona, Spain, 17007
    • Instituto Catalán de Oncología - Hospital Universitario Dr. Josep Trueta
  • Madrid, Spain
    • Hospital Clinico Universitario San Carlos
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marano
  • Málaga, Spain, 29017
    • Hospital Universitario Virgen de la Victoria
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocío
  • Valencia, Spain
    • Fundacion Instituto Valenciano de Oncologia Ivo
  • Castellón
    • Castelló de la Plana, Castellón, Spain, 12002
      • Hospital Provincial de Castellón
• Taiwan
  • Changhua, Taiwan
    • Changhua Christian Hospital
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University - Chung-Ho Memorial Hospital
  • Taichung, Taiwan
    • Tungs Taichung Metro Harbor Hospital
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
  • Tainan, Taiwan
    • Chi Mei Medical Center
  • Taipei, Taiwan
    • National Taiwan University Hospital NTUH
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital CGMH - LinKou Branch
• United Kingdom
  • London, United Kingdom
    • Imperial College Healthcare NHS Trust
  • London, United Kingdom
    • University College London Hospital
  • London, United Kingdom
    • Sarah Cannon Research Institute UK
  • Oxford, United Kingdom, OX4 6LB
    • Genesis Cancer Care-CHURCHILL Hospital Headington
  • Sutton, United Kingdom
    • Royal Marsden Hospital
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Oncology and Hematology LLC
  • Arizona
    • Tucson, Arizona, United States, 85741
      • Urological Associates of Southern Arizona PC
  • California
    • Rancho Mirage, California, United States, 92270
      • Desert Hematology Oncology Medical Group Inc
    • San Bernardino, California, United States, 92404
      • San Bernardino Urological Associates Medical Group
  • Florida
    • Jacksonville, Florida, United States, 32209
      • UF College of Medicine - Jacksonville
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Hematology Oncology Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins
    • Baltimore, Maryland, United States, 21201
      • VA Maryland Health Care System
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • GU Research Network LLC
  • New Jersey
    • Hackensack, New Jersey, United States, 76011
      • John Theurer Cancer Center
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Messino Cancer Centers
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology
  • Texas
    • Houston, Texas, United States, 77030
      • Center for Onology and Blood Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; Fuzuloparib plus AA-P	Drug: Fuzuloparib , Abiraterone acetate and Prednisone; 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
Placebo Comparator: Treatment group B; Fuzuloparib Placebo plus AA-P	Drug: Fuzuloparib Placebo， Abiraterone acetate and Prednisone; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3	progression-free survival	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	time from randomization to death due to any cause	up to 4 years
ORR	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	up to 3 years
Time to PSA progression	Time from randomisation to the first time of PSA progression according to the criterion of PCGW3	up to 3 years
Time to skeletal-related events	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.	up to 4 years

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Abiraterone Acetate; Prednisone
• Other Study ID Numbers: SHR3162-III-305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes