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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04691804




Registration number
NCT04691804
Ethics application status
Date submitted
30/12/2020
Date registered
31/12/2020
Date last updated
1/08/2022

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
SHR3162-III-305
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-Resistant Prostate Cancer (mCRPC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fuzuloparib , Abiraterone acetate and Prednisone
Treatment: Drugs - Fuzuloparib Placebo, Abiraterone acetate and Prednisone

Experimental: Treatment group A - Fuzuloparib plus AA-P

Placebo Comparator: Treatment group B - Fuzuloparib Placebo plus AA-P


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3
Timepoint [1] 0 0
up to 3 years
Secondary outcome [1] 0 0
OS
Timepoint [1] 0 0
up to 4 years
Secondary outcome [2] 0 0
ORR
Timepoint [2] 0 0
up to 3 years
Secondary outcome [3] 0 0
Time to PSA progression
Timepoint [3] 0 0
up to 3 years
Secondary outcome [4] 0 0
Time to skeletal-related events
Timepoint [4] 0 0
up to 4 years

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
804
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Bendigo Health - Bendigo
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [4] 0 0
Gosford Hospital - Gosford
Recruitment hospital [5] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Western Health - St Albans
Recruitment hospital [8] 0 0
Macquarie University - Sydney
Recruitment hospital [9] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [10] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 0 0
- Bendigo
Recruitment postcode(s) [2] 0 0
- Concord
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- Fitzroy
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- Gosford
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- Kurralta Park
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- Melbourne
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- St Albans
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- Sydney
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- Wagga Wagga
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- Wahroonga
Recruitment outside Australia
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Oxford
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Jiangsu HengRui Medicine Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04691804
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chunlei Jin, M.D.
Address 0 0
Country 0 0
Phone 0 0
18036618586
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04691804