AzTrials
AzTrials

Metastatic Castration-Resistant Prostate Cancer (mCRPC)Phase 3NCT04691804

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

A Phase 3 study testing Fuzuloparib , Abiraterone acetate and Prednisone in people with Metastatic Castration-Resistant Prostate Cancer (mCRPC), run by Jiangsu HengRui Medicine Co., Ltd. at 147 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Fuzuloparib , Abiraterone acetate and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
496 participants
Where
147 sitesin 13 countries
Study dates
18 Mar 2021to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

147 sites in 13 countries.

147 sites in 13 countries

China56 sites

  • Beijing cancer hospital

    Beijing

  • Beijing Friendship Hospital

    Beijing

  • Beijing Hospital

    Beijing

  • Cancer hospital Chinese academy of medical science

    Beijing

  • Hunan Cancer Hospital

    Changsha

  • XiangYa hospital central south university

    Changsha

  • Sichuan Provincial People's Hospital

    Chengdu

  • West China Hospital of Sichuan University

    Chengdu

  • Chongqing Cancer Hospital

    Chongqing

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

  • Fujian Medical University Union Hospital

    Fuzhou

  • The First affiliatared hospital of Fujian medical university

    Fuzhou

  • Cancer Center, Sun Yat-sen University

    Guangzhou

  • Sun Yet-Sen Memorial Hospital,Sun Yet-Sen University

    Guangzhou

  • Affiliated Hospital of Guizhou Medical University

    Guiyang

  • Guizhou Cancer Hospital

    Guiyang

  • Urology Ward 2，Harbin Medical University Cancer Hospital

    Ha’erbin

  • The First Affiliated Hospital，ZheJiang University School of Medicine

    Hangzhou

  • ZheJiang Provincial People's Hospital

    Hangzhou

  • Anhui Provincial Hospital

    Hefei

  • The First Affiliated Hospital Of Anhui Medical University

    Hefei

  • The Second Hospital Of Anhui Medical University

    Hefei

  • The First Hospital of Jiaxing

    Jiaxing

  • Qilu Hospital of Shandong University

    Jinan

  • Shandong Provincial Hospital

    Jinan

  • Yunnan Cancer Hospital

    Kunming

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • The Second Affiliated Hospital of Nanchang University-DepartmentDepartment of Urology

    Nanchang

  • JiangSu Cancer Hospital

    Nanjing

  • Jiangsu Province Hospitall

    Nanjing

  • Nanjing Drum Tower Hospital

    Nanjing

  • The first affiliated hospital of guangxi medical university

    Nanjing

  • ZhongDa hospital southeast university

    Nanjing

  • Qingdao Municipal Hospital

    Qingdao

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Changhai Hospital of Shanghai-Department of Urology

    Shanghai

  • Shanghai Tenth People's Hospital-Department of Urology

    Shanghai

  • The Urology Surgery department of Zhongshan Hospital

    Shanghai

  • Liaoning Cancer Hospital

    Shenyang

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang

  • First Hospital of Shanxi Medical University

    Taiyuan

  • Shanxi Provincial Cancer Hospital

    Taiyuan

  • The Second Hospital Of TianJin medical University

    Tianjin

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin

  • The Affiliated Tumor Hospital of Xinjiang Medical University-Department of Urology

    Ürümqi

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

  • Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology

    Wuhan

  • Union Hospital of Tongji Medical College,Huazhong University of Science and Technology

    Wuhan

  • Wuxi People's Hospital-Department of Urinary Surgery

    Wuxi

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Northern Jiangsu People's Hospital

    Yangzhou

  • Henan Cancer Hospital

    Zhengzhou

  • Henan Provincial People's Hospital

    Zhengzhou

Other trials in China

United States17 sites

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Messino Cancer Centers

    Asheville, North Carolina, 28806

  • VA Maryland Health Care System

    Baltimore, Maryland, 21201

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, 70809

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Tennessee Oncology

    Chattanooga, Tennessee, 37404

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • John Theurer Cancer Center

    Hackensack, New Jersey, 76011

  • Center for Onology and Blood Disorders

    Houston, Texas, 77030

  • UF College of Medicine - Jacksonville

    Jacksonville, Florida, 32209

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572

  • Weill Cornell Medicine

    New York, New York, 10021

  • GU Research Network LLC

    Omaha, Nebraska, 68130

  • Desert Hematology Oncology Medical Group Inc

    Rancho Mirage, California, 92270

  • San Bernardino Urological Associates Medical Group

    San Bernardino, California, 92404

  • Urological Associates of Southern Arizona PC

    Tucson, Arizona, 85741

Other trials in United States

Spain12 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clinico de Barcelona

    Barcelona

  • Hospital Universitari Parc Tauli

    Barcelona

  • Hospital Provincial de Castellón

    Castellon, Castellón, 12002

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Instituto Catalán de Oncología - Hospital Universitario Dr. Josep Trueta

    Girona, 17007

  • Hospital Clinico Universitario San Carlos

    Madrid

  • Hospital General Universitario Gregorio Marano

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29017

  • Hospital Universitario Virgen del Rocio

    Seville

  • Fundacion Instituto Valenciano de Oncologia IVO

    Valencia

Other trials in Spain

Australia10 sites

  • Bendigo Health

    Bendigo

  • Concord Repatriation General Hospital

    Concord

  • St Vincents Hospital Melbourne

    Fitzroy

  • Gosford Hospital

    Gosford

  • Ashford Cancer Centre Research

    Kurralta Park

  • The Alfred Hospital

    Melbourne

  • Western Health

    St Albans

  • Macquarie University

    Sydney

  • Riverina Cancer Care Centre

    Wagga Wagga

  • Sydney Adventist Hospital

    Wahroonga

Other trials in Australia

France10 sites

  • Centre Hospitalier Departemental Vendee CHD

    La Roche-sur-Yon

  • CHRU de Lille Hopital Claude Huriez

    Lille

  • Centre Leon Berard

    Lyon

  • Centre Hospitalier Universitaire de Nimes, Institut de Cancerologie du Gard

    Nîmes

  • Hopital Europeen George Pompidou

    Paris, 75908

  • Hopital Lyon Sud

    Pierre-Bénite

  • Centre Eugenie Marquis

    Rennes

  • Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau

    Saint-Herblain

  • Strasbourg Oncologie Liberale- Clinique Sainte Anne

    Strasbourg

  • Institut Univ du Cancer de Toulouse-Oncopole

    Toulouse

Other trials in France

Poland8 sites

  • Szpitale Pomorskie Sp.zo.o

    Gdynia

  • Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego

    Grudziądz

  • Clinical Research Center Sp. z o.o.

    Kobylniki

  • Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika

    Koszalin

  • University Hospital

    Krakow

  • Szpital Kliniczny Nr Pozna?

    Poznan

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie

    Warsaw

  • Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center

    Wroclaw

Other trials in Poland

South Korea7 sites

  • National Cancer Center

    Goyang

  • CHA Bundang Medical Center CHA University

    Seongnam

  • Seoul National University Bundang Hospital

    Seongnam

  • Asan Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital

    Seoul

  • Pusan National University Yangsan Hospital

    Yangsan

Other trials in South Korea

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City

  • Tungs Taichung Metro Harbor Hospital

    Taichung

  • Chi Mei Medical Center

    Tainan

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital NTUH

    Taipei

  • Chang Gung Memorial Hospital CGMH - Linkou Branch

    Taoyuan

Other trials in Taiwan

Hungary5 sites

  • National Institute of Oncology

    Budapest

  • Semmelweis Egyetem

    Budapest

  • Bekes Megyei Kozponti Korhaz

    Gyula

  • BKMK Hospital

    Kecskemét

  • Szent Borbala Korhaz

    Tatabánya

Other trials in Hungary

Russia5 sites

  • Ivanovo Regional Oncology Dispensary

    Ivanovo

  • Hertzen Moscow Oncology Research Center

    Moscow

  • Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N. Blokhin

    Moscow

  • Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary

    Omsk

  • Bashkortostan Republican Clinical Oncology Dispensary

    Ufa

Other trials in Russia

United Kingdom5 sites

  • Imperial College Healthcare NHS Trust

    London

  • Sarah Cannon Research Institute UK

    London

  • University College London Hospital

    London

  • Genesis Cancer Care-CHURCHILL Hospital Headington

    Oxford, OX4 6LB

  • Royal Marsden Hospital

    Sutton

Other trials in United Kingdom

Belgium3 sites

  • UZ Gent

    Ghent

  • Centre Hospitalier de Jolimont

    Haine-Saint-Paul

  • AZ Groeninge

    Kortrijk

Other trials in Belgium

Czechia2 sites

  • Nemocnice Novy Jicin a.s.

    Nový Jičín

  • Thomayerova Nemocnice

    Prague

Other trials in Czechia

About this study

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).

Being tested
Fuzuloparib , Abiraterone acetate and Prednisone, Fuzuloparib Placebo， Abiraterone acetate and Prednisone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fuzuloparib , Abiraterone acetate and PrednisoneDrug

    Also called SHR3162

    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 PrednisoneDrug

    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 groups in NCT04691804
Study groupRoleWhat they receive
Treatment group AExperimentalFuzuloparib plus AA-P
Receives: Drug: Fuzuloparib , Abiraterone acetate and Prednisone
Treatment group BPlacebo comparatorFuzuloparib Placebo plus AA-P
Receives: Drug: Fuzuloparib Placebo， Abiraterone acetate and Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    progression-free survival

    Measured: up to 3 years

Secondary outcomes (4)

  1. OS

    time from randomization to death due to any cause

    Measured: up to 4 years

  2. 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

    Measured: up to 3 years

  3. Time to PSA progression

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

    Measured: up to 3 years

  4. 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.

    Measured: up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2020
  2. Study start18 Mar 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Fuzuloparib Combined with Abiraterone Acetate and Prednisone (AA-P) versus Placebo Combined with AA-P
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
496 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04691804
Sponsor's protocol ID
SHR3162-III-305
Status last verified
Dec 2024
First submitted
30 Dec 2020
Last updated
31 Dec 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fuzuloparib , Abiraterone acetate and Prednisone in people with Metastatic Castration-Resistant Prostate Cancer (mCRPC), run by Jiangsu HengRui Medicine Co., Ltd. at 147 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in China, United States, Spain, Australia, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3 (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04691804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in