Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
This is a randomised, triple-blind trial with an experimental arm and a placebo comparator arm. In the Experimental Arm, participants will receive Fuzuloparib plus Abiraterone acetate and Prednisone (AA-P). Fuzuloparib will be administered at a dose of 150mg, orally, twice a day. Abiraterone acetate will be administered at a dose of 1000mg, orally, once daily. Prednisone will be administered at a dose of 5mg, orally, twice a day. In the Placebo Comparator Arm, participants will receive a Fuzuloparib placebo plus AA-P. The Fuzuloparib placebo will be administered at a dose of 150mg, orally, twice a day. Abiraterone acetate will be administered at a dose of 1000mg, orally, once daily. Finally, Prednisone will be administered at a dose of 5mg, orally, twice a day.
Conditions
This trial is treating people with metastatic castration-resistant prostate cancer
Eligibility
Inclusion
- Able and willing to provide a written informed consent
- A score of 0 to 1 for ECOG performance status
- Age of ≥ 18 years old
- Prostate adenocarcinoma confirmed
- Disease progression of metastatic prostate cancer while the subject was on androgen deprivation therapy.
- The functional level of the organs must meet the requirements
- Blood and tumor tissue samples are provided during screening to determine the DRD status
Exclusion
- Prior treatment with any PARP inhibitor
- Have received any systemic anti-tumor treatment during the mCRPC stage or non-metastatic CRPC stage
- Have used any CYP3A4 inducers or inhibitors within 14 days prior to the first dose
- Plan to receive any other anti-tumor treatment
- Presence of radiologically confirmed tumor lesions in the brain
- Contraindications to the use of Prednisone
- History of uncontrolled pituitary or adrenal dysfunction
- Uncontrolled hypertension
- Presence of active heart diseases
- Human immunodeficiency virus-positive
- Presence of dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption
- Active HBV or HCV infection
- Presence of concomitant diseases
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Jiangsu HengRui Medicine Co., Ltd.
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
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information