A Ph3 study of Fuzuloparib + AA-P vs Placebo + AA-P in Prostate Cancer
Research type
Research Study
Full 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
IRAS ID
301120
Contact name
Dr. Naveed Sarwar
Contact email
Sponsor organisation
Jiangsu Hengrui Pharmaceuticals Co., Ltd
Eudract number
2020-006063-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
This is a randomised, double-blind, placebo-controlled international multicentre phase 3 study in patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).
The main purpose of this clinical research study is to evaluate a potential new medication called Fuzuloparib Capsules (SHR3162) in patients have been diagnosed with Metastatic Castration-Resistant Prostate Cancer that has spread to other parts of the body, such as bones and /or other organs.
Fuzuloparib is being developed by the sponsor Jiangsu Hengrui Medicine Co, Ltd (JHM), a pharmaceutical company with headquarters in China. This investigational medication is not approved for mCRPC treatment by any health authority. Fuzuloparib belongs to a class of anti-cancer agents known as PARP inhibitors. PARP inhibitors are a type of targeted cancer therapy that block an enzyme in cells called PARP. PARP helps repair DNA when it becomes damaged. In cancer treatment, blocking PARP may help keep cancer cells from repairing their damaged DNA, causing the cancer cell to die.
In this study, participants will receive either Fuzuloparib or a placebo (that is, ‘dummy treatment’), and additionally abiraterone acetate tablets and prednisone tablets. Abiraterone acetate is often used combined with prednisone in clinical practice and is the standard treatment for advanced mCRPC.
Approximately 800 patients with mCRPC will participate in this study in various countries. In the UK, 7 participants will be included. Study participants will receive the study medication in 28-day cycles until disease progression, withdrawal by the participant, unacceptable side effects, or when the study doctor deems it necessary to withdraw the participants from the study (whichever occurs first). The study will take about 6 and a half years to complete.
REC name
London - Chelsea Research Ethics Committee
REC reference
21/LO/0632
Date of REC Opinion
8 Feb 2022
REC opinion
Further Information Favourable Opinion