Active not recruitingPHASE3INTERVENTIONAL

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

This clinical trial is investigating a new treatment approach for men with prostate cancer that has spread to other parts of the body and is no longer responding well to hormone therapy. This type of cancer is called metastatic castration-resistant prostate cancer (mCRPC). The study aims to see if adding an experimental drug called Fuzuloparib to the usual treatment of abiraterone acetate and prednisone can better slow down the cancer's spread. Researchers want to find out if this new combination keeps the cancer from growing for longer compared to the standard treatment alone. They will be looking at this in all eligible patients, and also specifically in those whose cancer has certain genetic changes related to DNA repair.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrolment target

496

Start

18 Mar 2021

Estimated completion

31 Dec 2026

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

What is this study about?

This research study is focused on a type of prostate cancer that has spread to other parts of the body (metastatic) and has become resistant to standard hormone treatments (castration-resistant). This is often a challenging stage of prostate cancer, and doctors are always looking for new and more effective ways to treat it.

The main goal of this study is to test a new drug called Fuzuloparib. This drug is given alongside treatments that are already commonly used for this type of prostate cancer: abiraterone acetate and prednisone. The study will compare patients who receive the new drug combination with those who receive the standard treatments plus a placebo (a dummy pill that looks like Fuzuloparib but contains no active medicine). This comparison helps the researchers understand if Fuzuloparib genuinely adds benefit.

The researchers will be paying close attention to whether the cancer grows or spreads. They want to see if the new combination therapy can keep the cancer from getting worse for a longer period of time. They are looking at all patients, and also specifically at a group whose cancer has particular genetic changes that might mean they respond better to treatments like Fuzuloparib. This will help doctors understand which patients might benefit most from this new treatment in the future.

Key takeaways

Tests a new drug (Fuzuloparib) for advanced prostate cancer.
Compares it against standard treatment for better cancer control.
Specifically looking at slowing cancer growth and spread.
Recruiting men with metastatic castration-resistant prostate cancer.
Participation involves regular medical checks and scans.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you would generally need to be an adult man, 18 years or older, with prostate cancer that has spread and is no longer responding to hormone therapy. Your original prostate cancer diagnosis must be confirmed, and your cancer should have progressed even while you were on hormone treatment. You'd also need to be in good general health, able to carry out most daily activities without too much difficulty.

There are also some reasons why you might not be able to join. For example, if you've already had a specific type of treatment called a PARP inhibitor, or if you've recently had other cancer treatments for your advanced prostate cancer. You also wouldn't be able to join if you have certain other medical conditions, like active heart problems, uncontrolled high blood pressure, or a history of serious brain lesions. The study also cannot include individuals with certain infections like HIV, active Hepatitis B or C, or if you have digestive issues that might prevent you from properly absorbing the study medication.

Quick self-check

Are you an adult man, 18 years or older?
Do you have prostate cancer that has spread?
Is your prostate cancer no longer responding to hormone therapy?
Are you generally well and able to perform daily activities?
Have you NOT previously taken a PARP inhibitor drug?
Do you NOT have serious uncontrolled heart conditions or specific infections like HIV?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups by chance – like drawing lots. Neither you nor your study doctor will know which group you are in (this is called 'double-blind'). One group will receive Fuzuloparib plus the standard treatments (abiraterone acetate and prednisone), while the other group will receive a placebo (a dummy pill) along with the standard treatments.

You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your cancer and overall health. You will also need to provide blood and tissue samples at the beginning to help understand your cancer's genetic makeup. The medications will likely be taken by mouth, possibly requiring daily doses. The study will continue as long as the treatment is helping you and you are not experiencing significant side effects. There will be ongoing follow-up to monitor your health and the progress of your cancer.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the new combination treatment proves to be more effective than current standard care in slowing down your cancer's growth. However, there's no guarantee that you will personally benefit. As with any medication, there are potential risks and side effects associated with Fuzuloparib, abiraterone acetate, and prednisone, which the study doctors will explain fully. These could range from mild to serious. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (147)

Alaska Oncology and Hematology LLC
Anchorage, United States
Urological Associates of Southern Arizona PC
Tucson, United States
Desert Hematology Oncology Medical Group Inc
Rancho Mirage, United States
San Bernardino Urological Associates Medical Group
San Bernardino, United States
UF College of Medicine - Jacksonville
Jacksonville, United States
Hematology Oncology Clinic
Baton Rouge, United States
VA Maryland Health Care System
Baltimore, United States
Johns Hopkins
Baltimore, United States
Henry Ford Health System
Detroit, United States
GU Research Network LLC
Omaha, United States
John Theurer Cancer Center
Hackensack, United States
Weill Cornell Medicine
New York, United States

+135 more sites — see the official record for the full list.

Common questions

What does 'metastatic castration-resistant prostate cancer' mean?

It means the prostate cancer has spread to other parts of your body (metastatic) and is no longer being controlled by hormone therapy (castration-resistant).

What is Fuzuloparib?

Fuzuloparib is an experimental drug being tested in this study. It's designed to work differently from current treatments, aiming to further slow down cancer growth.

Why don't I know if I'm getting the new drug or the placebo?

This is a 'double-blind' study. It helps ensure the results are fair and unbiased, as knowing which treatment you're on could affect how you report symptoms or how doctors assess your progress.

What is a 'DNA damage repair deficiency'?

Some cancers have natural weaknesses in how they repair their DNA. This can make them more sensitive to certain treatments. The study is also looking at patients with these specific weaknesses.

Will I have to pay to be in the study?

Typically, all study-related treatments, medical exams, and procedures are provided to you at no cost when you participate in a clinical trial.