Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Conditions
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).
Interventions
DRUGFuzuloparib , 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
DRUGFuzuloparib 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
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Fuzuloparib Combined with Abiraterone Acetate and Prednisone (AA-P) versus Placebo Combined with AA-P
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3 | up to 3 years | progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | up to 4 years | time from randomization to death due to any cause |
| ORR | 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 |
| Time to PSA progression | up to 3 years | Time from randomisation to the first time of PSA progression according to the criterion of PCGW3 |
| Time to skeletal-related events | 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. |
Countries
Australia, Belgium, China, Czechia, France, Hungary, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed