Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT04691804 : 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

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Systemic therapy | Urinary systemProstate

Trial Overview Read MoreRead more

This phase III trial is evaluating the effectiveness of targeted therapy (fuzuloparib), compared to a placebo, in combination with hormone therapy and steroids (abiraterone acetate and prednisone [AA-P]) in people with metastatic castration-resistant prostate cancer.
 

This trial is treating patients with metastatic castration-resistant prostate cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Commercial Sponsor

Jiangsu HengRui Medicine Co., Ltd.

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.

Recruiting Hospitals Read MoreRead more

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
oncology.research@svha.org.au
03 9231 3167

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
CancerClinicalTrials@wh.org.au
0434 915 739

Not Recruiting Hospitals Read MoreRead more

Closed

Alfred Hospital, Medical Oncology
Prahran
Mrs Cora Place
gl.place@alfred.org.au
03 9076 7464

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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