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

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Treatments: Drug: Fuzuloparib Placebo， Abiraterone acetate and Prednisone; Drug: Fuzuloparib , Abiraterone acetate and Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT04691804

SHR3162-III-305

Details and patient eligibility

About

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).

Enrollment: 804 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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804 participants in 2 patient groups, including a placebo group

Treatment group A

Experimental group

Description:

Fuzuloparib plus AA-P

Treatment:

Drug: Fuzuloparib , Abiraterone acetate and Prednisone

Treatment group B

Placebo Comparator group

Description:

Fuzuloparib Placebo plus AA-P

Treatment:

Drug: Fuzuloparib Placebo， Abiraterone acetate and Prednisone