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

Metastatic Castration-Resistant Prostate Cancer (mCRPC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691804
• Other study ID #: SHR3162-III-305
• Status: Recruiting
• Phase: Phase 3
• Start date: March 18, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Chunlei Jin, M.D.
• Phone: 18036618586
• Email: chunlei.jin[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 804
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Australia	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
Belgium	UZ Gent	Gent
Belgium	Centre Hospitalier de Jolimont	Haine Saint Paul
Belgium	AZ Groeninge	Kortrijk
China	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	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou
China	The First affiliatared hospital of Fujian medical university	Fuzhou
China	Cancer Center, Sun Yat-sen University	Guangzhou
China	Sun Yet-Sen Memorial Hospital,Sun Yet-Sen University	Guangzhou
China	Affiliated Hospital of Guizhou Medical University	Guiyang
China	Guizhou Cancer Hospital	Guiyang
China	Urology Ward 2,Harbin Medical University Cancer Hospital	Ha'erbin
China	The First Affiliated Hospital,ZheJiang University School of Medicine	Hangzhou
China	ZheJiang Provincial People's Hospital	Hangzhou
China	Anhui Provincial Hospital	Hefei
China	The First Affiliated Hospital Of Anhui Medical University	Hefei
China	The Second Hospital Of Anhui Medical University	Hefei
China	The First Hospital of Jiaxing	Jiaxing
China	Qilu Hospital of Shandong University	Jinan
China	Shandong Provincial Hospital	Jinan
China	Yunnan Cancer Hospital	Kunming
China	The First Affiliated Hospital of Nanchang University	Nanchang
China	The Second Affiliated Hospital of Nanchang University-DepartmentDepartment of Urology	Nanchang
China	JiangSu Cancer Hospital	NanJing
China	Jiangsu Province Hospitall	NanJing
China	Nanjing Drum Tower Hospital	NanJing
China	The first affiliated hospital of guangxi medical university	Nanjing
China	ZhongDa hospital southeast university	Nanjing
China	Qingdao Municipal Hospital	Qingdao
China	Changhai Hospital of Shanghai-Department of Urology	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanghai Tenth People's Hospital-Department of Urology	Shanghai
China	The Urology Surgery department of Zhongshan Hospital	ShangHai
China	Liaoning Cancer Hospital	Shenyang
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang
China	First Hospital of Shanxi Medical University	Taiyuan
China	Shanxi Provincial Cancer Hospital	Taiyuan
China	The Second Hospital Of TianJin medical University	Tianjin
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin
China	The Affiliated Tumor Hospital of Xinjiang Medical University-Department of Urology	Urumqi
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou
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	Wuhan
China	Wuxi People's Hospital-Department of Urinary Surgery	WuXi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou
China	Northern Jiangsu People's Hospital	YangZhou
China	Henan Cancer Hospital	Zhengzhou
China	Henan Provincial People's Hospital	Zhengzhou
Czechia	Nemocnice Novy Jicin a.s.	Novy Jicin
Czechia	Thomayerova Nemocnice	Prague
France	Centre Hospitalier Departemental Vendee CHD	La Roche-sur-Yon
France	CHRU de Lille Hopital Claude Huriez	Lille
France	Centre Leon Berard	Lyon
France	Centre Hospitalier Universitaire de Nimes, Institut de Cancerologie du Gard	Nimes
France	Hopital Europeen George Pompidou	Paris
France	Hopital Lyon Sud	Pierre-Benite
France	Centre Eugenie Marquis	Rennes
France	Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau	Saint-Herblain
France	Strasbourg Oncologie Liberale- Clinique Sainte Anne	Strasbourg
France	Institut Univ du Cancer de Toulouse-Oncopole	Toulouse
Hungary	National Institute of Oncology	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Bekes Megyei Kozponti Korhaz	Gyula
Hungary	BKMK Hospital	Kecskemét
Hungary	Szent Borbala Korhaz	Tatabanya
Korea, Republic of	National Cancer Center	Goyang
Korea, Republic of	CHA Bundang Medical Center CHA University	Seongnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan
Poland	Szpitale Pomorskie Sp.zo.o	Gdynia
Poland	Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego	Grudziadz
Poland	Clinical Research Center Sp. z o.o.	Kobylniki
Poland	Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika	Koszalin
Poland	University Hospital	Krakow
Poland	Szpital Kliniczny Nr Pozna?	Poznan
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie	Warszawa
Poland	Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center	Wroclaw
Russian Federation	Ivanovo Regional Oncology Dispensary	Ivanovo
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	Moscow
Russian Federation	Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary	Omsk
Russian Federation	Bashkortostan Republican Clinical Oncology Dispensary	Ufa
Spain	Hospital Clinico de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Parc Tauli	Barcelona
Spain	Hospital Provincial de Castellón	Castelló de la Plana	Castellón
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Instituto Catalán de Oncología - Hospital Universitario Dr. Josep Trueta	Girona
Spain	Hospital Clinico Universitario San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marano	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Fundacion Instituto Valenciano de Oncologia IVO	Valencia
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Kaohsiung Medical University - Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Tungs Taichung Metro Harbor Hospital	Taichung
Taiwan	Chi Mei Medical Center	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital NTUH	Taipei
Taiwan	Chang Gung Memorial Hospital CGMH - Linkou Branch	Taoyuan
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Sarah Cannon Research Institute UK	London
United Kingdom	University College London Hospital	London
United Kingdom	Genesis Cancer Care-CHURCHILL Hospital Headington	Oxford
United Kingdom	Royal Marsden Hospital	Sutton
United States	Alaska Oncology and Hematology LLC	Anchorage	Alaska
United States	Messino Cancer Centers	Asheville	North Carolina
United States	Johns Hopkins	Baltimore	Maryland
United States	VA Maryland Health Care System	Baltimore	Maryland
United States	Hematology Oncology Clinic	Baton Rouge	Louisiana
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	Tennessee Oncology	Chattanooga	Tennessee
United States	Henry Ford Health System	Detroit	Michigan
United States	John Theurer Cancer Center	Hackensack	New Jersey
United States	Center for Onology and Blood Disorders	Houston	Texas
United States	UF College of Medicine - Jacksonville	Jacksonville	Florida
United States	Carolina Urologic Research Center, LLC	Myrtle Beach	South Carolina
United States	Weill Cornell Medicine	New York	New York
United States	GU Research Network LLC	Omaha	Nebraska
United States	Desert Hematology Oncology Medical Group Inc	Rancho Mirage	California
United States	San Bernardino Urological Associates Medical Group	San Bernardino	California
United States	Urological Associates of Southern Arizona PC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  China,  Czechia,  France,  Hungary,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3	progression-free survival	up to 3 years
Secondary	OS	time from randomization to death due to any cause	up to 4 years
Secondary	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
Secondary	Time to PSA progression	Time from randomisation to the first time of PSA progression according to the criterion of PCGW3	up to 3 years
Secondary	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