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
Conditions
Metastatic Castration-Resistant Prostate Cancer (mCRPC)Drugs
Fuzuloparib , Abiraterone acetate and Prednisone, Fuzuloparib Placebo, Abiraterone acetate and PrednisoneSummary
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).
Locations
9 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Steven Liu
Status
- RECRUITING
Contact Person
- Curtis Dunshee
Status
- RECRUITING
Contact Person
- Luke Dreisbach
Status
- RECRUITING
Contact Person
- Michael Castine
Status
- RECRUITING
Contact Person
- Channing Paller
Status
- RECRUITING
Contact Person
- Clara Hwang
Status
- RECRUITING
Contact Person
- Luke Nordquist
Status
- RECRUITING
Contact Person
- Christopher Chay
Status
- RECRUITING
Contact Person
- Edward Arrowsmith
Eligibility 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
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
Treatment group A
EXPERIMENTAL
Fuzuloparib plus AA-P
DRUG:
Fuzuloparib , Abiraterone acetate and PrednisoneDescription:
1. Fuzuloparib capsules (strength: 50 mg),150mg, Bid,pon2. Abiraterone acetate tablets (strength: 250 mg) 1000mg Qd,pon3. Prednisone tablets (strength: 5 mg) 5mg, Bid po
Treatment group B
PLACEBO_COMPARATOR
Fuzuloparib Placebo plus AA-P
DRUG:
Fuzuloparib Placebouff0c Abiraterone acetate and PrednisoneDescription:
1. Fuzuloparib capsules Placebo (strength: 50 mg),150mg, Bid,pon2. Abiraterone acetate tablets (strength: 250 mg)1000mg Qd,pon3. Prednisone tablets (strength: 5 mg)5mg, Bid po
Outcome Measures
Primary Outcome Measures
rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3
Secondary Outcome Measures
OS
ORR
Time to PSA progression
Time to skeletal-related events
Timeline
Last Updated
August 1, 2022Start Date
December 31, 2020Today
February 5, 2025Completion Date ( Estimated )
December 31, 2026
Sponsors of this trial
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.