Active not recruitingPHASE3INTERVENTIONAL

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

This research study is for men with metastatic castration-sensitive prostate cancer (mCSPC). This means the prostate cancer has spread to other parts of the body but is still being controlled by hormone treatment. The study is comparing a new drug called Saruparib with a dummy pill (placebo). Both Saruparib and the placebo are given alongside standard hormone treatments that doctors currently use, such as Abiraterone, Darolutamide, or Enzalutamide. The main goal is to find out if adding Saruparib helps slow down the cancer's growth or spread more effectively than the standard treatment alone, as seen on scans. We hope this could lead to more effective treatments for prostate cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,889

Start

21 Nov 2023

Estimated completion

30 Apr 2031

Metastatic Castration-Sensitive Prostate Cancer

What is this study about?

This study is designed to look at a new medication called Saruparib for men who have prostate cancer that has spread to other parts of the body (metastatic) but is still responding to hormone therapy (castration-sensitive). This type of prostate cancer is currently treated with hormone drugs, which work by lowering the amount of male hormones that can fuel the cancer's growth. Researchers want to see if adding Saruparib to these standard hormone treatments can make them even more effective.

The main question this study is trying to answer is whether combining Saruparib with the usual hormone treatments can stop the cancer from growing or spreading for longer than the usual hormone treatments by themselves. Participants will be split into two groups – one group will receive Saruparib plus their hormone treatment, and the other will receive a placebo (an inactive pill) plus their hormone treatment. This comparison helps researchers understand the true effect of Saruparib.

This research is important because it could potentially offer a new and improved treatment option for men with this type of prostate cancer. If Saruparib proves to be effective, it could help patients live longer and maintain a better quality of life by slowing down the progression of their disease.

Key takeaways

This study is for men with advanced prostate cancer still responding to hormone treatment.
It compares a new drug, Saruparib, with a dummy pill (placebo), both given alongside standard hormone therapy.
The aim is to see if Saruparib can slow down cancer growth or spread more effectively.
You will have regular scans and check-ups to monitor your health and cancer.
Participation is voluntary, and you can leave the study at any time.
An independent committee will monitor the study's safety.

Who may be eligible?

This study is looking for men aged 18 or older who have been diagnosed with prostate cancer that has spread to other parts of the body, such as bones or soft tissues, and is still responding to hormone treatment. Your specific type of prostate cancer needs to be confirmed by a doctor, making sure it doesn't have certain rare cell types. You should also be generally in good health and able to move around without much difficulty.

To join, you must already be receiving hormone therapy, such as injections or tablets that lower male hormones, and have started this treatment between two weeks and four months before joining the study. You will also need to provide tissue and blood samples to help us understand your cancer better, including looking at certain genetic changes in your cancer cells (called HRRm status).

There are also some reasons why you might not be able to join. For example, if you have a history of certain serious blood disorders, bleeding problems, or severe ongoing low blood counts. Also, if you have difficulty swallowing pills or have had major bowel surgery that might affect how your body absorbs medication, or if you've had certain other cancers in the past, you might not be eligible.

Quick self-check

Are you a man aged 18 or older?
Do you have prostate cancer that has spread to other parts of your body?
Is your prostate cancer currently being treated with hormone therapy and responding to it?
Are you able to provide tissue and blood samples?
Are you in reasonably good general health?
Do you have any history of serious blood disorders or ongoing bleeding problems?

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 by chance (like flipping a coin) to one of two groups. One group will receive the new drug Saruparib along with your current hormone therapy, and the other group will receive a dummy pill (placebo) along with your current hormone therapy. You won't know which group you're in. You'll take your assigned treatment regularly, and you'll have regular scans (like CT or MRI) to check on your cancer. These scans will continue until your cancer shows signs of growing or spreading, or if you need to stop treatment for another reason.

After you stop taking the study medication, doctors will continue to follow your health and survival until the very end of the study. An independent group of experts will keep a close eye on the study to make sure the treatment is safe for everyone taking part. The total duration of your participation, including follow-up, will vary, as you will be followed until the study's conclusion, which could be several years.

Potential risks and benefits

Participating in this study might offer you access to a new treatment, Saruparib, which could potentially slow down your prostate cancer more effectively than current standard treatments. However, there's also a chance you could receive the placebo, meaning you wouldn't get the new drug. As with any medication, Saruparib might cause side effects, which the study team will monitor closely. You will receive regular check-ups and scans to monitor your health and cancer. It's important to remember that joining a clinical study is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (322)

Research Site
Chandler, United States
Research Site
Gilbert, United States
Research Site
Phoenix, United States
Research Site
Tucson, United States
Research Site
Little Rock, United States
Research Site
Springdale, United States
Research Site
Bakersfield, United States
Research Site
Fountain Valley, United States
Research Site
Fullerton, United States
Research Site
Los Angeles, United States
Research Site
Montebello, United States
Research Site
San Francisco, United States

+310 more sites — see the official record for the full list.

Common questions

What is 'metastatic castration-sensitive prostate cancer'?

This means your prostate cancer has spread to other parts of the body (metastatic), but it is still responding to treatments that lower male hormones (castration-sensitive).

What is Saruparib?

Saruparib is a new drug being tested to see if it can improve how well your current hormone treatments work for prostate cancer.

What is a 'placebo'?

A placebo is an inactive pill that looks just like the study drug. It helps researchers compare the effects of the new drug against not having it.

Will I know if I'm getting Saruparib or the placebo?

No, you won't know which treatment you are receiving. This is called a 'blinded' study and helps ensure the results are accurate.

What is the main goal of this study?

The main goal is to see if adding Saruparib to your current hormone therapy can stop your cancer from growing or spreading for a longer time compared to hormone therapy alone.