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

December 30, 2024 updated by: Jiangsu HengRui Medicine Co., Ltd.
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
496

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Hopital 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 Rocio
      • Valencia, Spain
        • Fundacion Instituto Valenciano de Oncologia Ivo
    • Castellón
      • Castelló de la Plana, Castellón, Spain, 12002
        • Hospital Provincial de Castellon
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group A
Fuzuloparib plus AA-P
Drug: 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
Other Names:
  • SHR3162
Placebo Comparator: Treatment group B
Fuzuloparib Placebo plus AA-P
Drug: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3
Time Frame: up to 3 years
progression-free survival
up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OS
Time Frame: up to 4 years
time from randomization to death due to any cause
up to 4 years
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
up to 3 years
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
up to 3 years
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.
up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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